Infections, StreptococcalNCT02838407
Identification and Characterization of Bacteria in the Lungs of Children From 6 Months up to 6 Years Old, With Suspected Infection of the Lungs, in Spain.
A study testing BAL fluid sampling and Nasopharyngeal swab sampling in people with Infections, Streptococcal, run by GlaxoSmithKline at 7 sites in Spain.
Trial summary
The purpose of this study is to identify and characterise bacteria present in the lower airways of children with suspected chronic LRTIs and for whom bronchoalveolar lavage (BAL) is indicated by the clinician. Read more about this study
- Who is it for?
- Ages 6 months to 6 years
- Conditions the study is for
- Infections, Streptococcal
- What is being tested?
- BAL fluid sampling and Nasopharyngeal swab sampling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 197 participants
- Where
- 7 sitesSpain
- Study dates
- 23 Sep 2013to 23 Sep 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Subjects who the investigator believes that parent(s)/ legally acceptable representatives (LAR[s]) can and will comply with the requirements of the protocol.
- A male or female subject aged ≥ 6 months to < 6 years at the time of enrolment.
- Subjects meet the case definition of suspected chronic LRTIs where BAL is indicated.
- Subject's parent(s)/ LAR(s) agree to the collection of a nasopharyngeal swab from the subject.
- Written informed consent obtained from the parent(s)/ LAR(s) of the subject.
Who cannot join
- Known cystic fibrosis, immunosuppression, or other severe immunodeficiencies such as agammaglobu-linaemia, T cell deficiency or Human Immunodeficiency Virus/ Acquired Immune Deficiency Syndrome, chemotherapy treatment, etc.
- Exacerbation of persistent respiratory symptoms (cough, wheezing, difficulty in breathing, etc.) in the previous 2 weeks.
- Antibiotic treatment in the 2 weeks prior to study entry.
- Concurrent participation in another study within 30 days prior to study entry or at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).
- Subjects having previously participated in this study.
- Child in care.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Spain7 sites
GSK Investigational Site
Barakaldo (Vizcaya), 48903
GSK Investigational Site
Barcelona, 08035
GSK Investigational Site
Madrid, 28009
GSK Investigational Site
Madrid, 28046
GSK Investigational Site
Murcia (El Palmar), 30120
GSK Investigational Site
Sabadell (Barcelona), 08208
GSK Investigational Site
Valencia, 46010
About this study
Official title: Identification and Characterization of Bacteria in the Lower Airways of Children Aged ≥ 6 Months to < 6 Years With Suspected Lower Respiratory Tract Infections (LRTI) in Spain.
The purpose of this study is to identify and characterise bacteria present in the lower airways of children with suspected chronic LRTIs and for whom bronchoalveolar lavage (BAL) is indicated by the clinician.
- Conditions
- Infections, Streptococcal
- Being tested
- BAL fluid sampling, Nasopharyngeal swab sampling
- Keywords
- Chronic lower respiratory tract infection, Bonchoalveolar lavage, Nasopharyngeal swabs
- Medical subject headings
- Streptococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BAL fluid samplingOther
Following routine BAL procedures at the hospital, collection of BAL fluid samples: at least 2 mL, at Day 0.
Nasopharyngeal swab samplingOther
1 swab, Day 0
| Study group | Role | What they receive |
|---|---|---|
| Total group | Other | All enrolled subjects, male or female aged between 6 months included and less than 6 years at the time of enrollment, who visited the hospital with suspected chronic lower respiratory tract infections (LRTIs) and who had an indication for bronchoalveolar lavage (BAL). Receives: Other: BAL fluid sampling; Other: Nasopharyngeal swab sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects With Bacterial Aetiology, Assessed by Culture Growth, From Bronchoalveolar Lavage (BAL) Fluid Samples
Bacterial aetiology was assessed by culture growth from BAL fluid sample for Steptococcus pneumoniae (S.p.), Haemophilus influenzae (H.i.) and Moraxella catarrhalis (M.c.) , through either qualitative or quantitative bacterial identification (B.I.). The categories assessed were: positive (Pos.), negative (Neg.) and Missing (Mis.). For quantitative bacterial identification, S.p., H.i. and M.c. were confirmed by bacterial identification load higher than (>) 10^4 colony forming units per milliliter (cfu/mL), if bacterial species were present alone, or >10^5 cfu/mL if present as co-infection.
Note: For one subject who underwent BAL procedure, no BAL fluid was available for study analyses.
Measured: From Day 0 up to Year 2
Number of Subjects With Bacterial Aetiology Characteristics in BAL Fluid Samples
- pneumoniae (S.p.), H. influenzae (H.i.) and M. catarrhalis (M.c.) were confirmed by bacterial identification (B.I.) load higher than (>) 10^4 colony forming units per milliliter (cfu/mL), if bacterial species were present alone, or >10^5 cfu/mL if presented as co-infection. Analysis was also performed for other bacterial pathogens alone or as co-infection.
Note: For one subject who underwent BAL procedure, no BAL fluid was available for study analyses
Measured: From Day 0 up to Year 2
Number of Subjects With Bacterial Identification >10^4 Cfu/mL in BAL Fluid Samples (S. Pneumoniae and H. Influenzae Results for the "Negative M. Catarrhalis" BAL Fluid Samples Results Category)
- pneumoniae, H. influenzae and M. catarrhalis were confirmed by bacterial identification load higher than (>) 10^4 colony forming units per milliliter (cfu/mL), if bacterial species were present alone. Bacterial load referred to Negative M. catarrhalis - Negative S. pneumoniae - Negative H. influenzae (N.M.c.-N.S.p.-N.H.i.), Negative M. catarrhalis - Negative S. pneumoniae - Positive H. influenzae (N.M.c.-N.S.p.-P.H.i.), Negative M. catarrhalis - Positive S. pneumoniae - Negative H. influenzae (N.M.c.-P.S.p.-N.H.i.), Negative M. catarrhalis - Positive S. pneumoniae - Positive H. influenzae (N.M.c.-P.S.p.-P..H.i.).
Notes: bacterial identification for the N.M.c.-P.S.p.-P.H.i. category was confirmed as a co-infection with a bacterial load >10^5 cfu/mL. For one subject who underwent BAL procedure, no BAL fluid was available for study analyses.
Measured: From Day 0 up to Year 2
Number of Subjects With Bacterial Identification >10^4 Cfu/mL in BAL Fluid Samples (S. Pneumoniae and H. Influenzae Results for the "Positive M. Catarrhalis" BAL Fluid Samples Results Category)
- pneumoniae, H. influenzae and M. catarrhalis were confirmed by bacterial identification load higher than (>) 10^4 colony forming units per milliliter (cfu/mL), if bacterial species were present alone and by bacterial load >10^5 cfu/mL if presented as co-infection.
Categories referred to Positive M. catarrhalis -Negative S. pneumoniae - Negative H. influenzae (P.M.c.-N.S.p.-N.H.i.), Positive M. catarrhalis -Negative S. pneumoniae - Positive H. influenzae (P.M.c.-N.S.p.-P.H.i.), Positive M. catarrhalis - Positive S. pneumoniae - Negative H. influenzae (P.M.c.-P.S.p.-N.H.i.), Positive M. catarrhalis - Positive S. pneumoniae - Positive H. influenzae (P.M.c.-P.S.p.-P.H.i.). Notes: bacterial identification for the P.M.c.-N.S.p.-P.H.i., P.M.c.-P.S.p.-N.H.i. and P.M.c.-P.S.p.-P.H.i. categories was confirmed by a bacterial identification >10^5 cfu/mL. For one subject who underwent BAL procedure, no BAL fluid was available for study analyses
Measured: From Day 0 up to Year 2
Secondary outcomes (40)
Number of Subjects With Bacterial Colonization, Assessed by Culture Growth, From Nasopharyngeal Swab Samples
Bacterial colonization was assessed by culture growth from nasopharyngeal swab samples for S. pneumoniae, H. influenzae and M. catarrhalis, through either qualitative or quantitative bacterial identification (B.I.). The categories assessed were: positive (Pos.) and negative (Neg.).
Measured: From Day 0 up to Year 2
Bacterial Load Detected (log10 Transformation) by Quantitative Culture Growth, From BAL Fluid Samples
Bacterial load was detected by quantitative culture growth from BAL fluid samples for S. pneumoniae, H. influenzae and M. catarrhalis and expressed in colony-forming unit/ milliliter (cfu/mL). Quantitative bacterial identification was used to indicate the presence of bacterial pathogen load >10^4 cfu/mL if present alone or > 10^5 cfu/mL if present as co-infection. Note: For one subject who underwent BAL procedure, no BAL fluid was available for study analyses.
Measured: From Day 0 up to Year 2
Bacterial Load Detected (log10 Transformation) by Quantitative Molecular Techniques (Polymerase Chain Reaction) From BAL Fluid Samples
Bacterial load was detected by quantitative molecular techniques (PCR) from BAL fluid samples for S. pneumoniae, H. influenzae and M. catarrhalis and expressed in colony-forming unit/milliliter (cfu/mL). Quantitative bacterial identification was used to indicate the presence of bacterial pathogen load >10^4 cfu/mL if present alone or > 10^5 cfu/mL if present as co-infection.
Note: For one subject who underwent BAL procedure, no BAL fluid was available for study analyses.
Measured: From Day 0 up to Year 2
Number of Subjects With Other Bacterial Pathogens Detected by Qualitative Culture, From BAL Fluid Samples
Bacterial pathogens were detected by qualitative culture from BAL fluid samples and included:
Staphylococcus aureus, Pseudomonas aeruginosa, Stenotrophomonas maltophilia and Pseudomonas putida.
Note: For one subject who underwent BAL procedure, no BAL fluid was available for study analyses.
Measured: From Day 0 up to Year 2
Bacterial Load Detected (log10 Transformation) by Quantitative Culture From Nasopharyngeal Swab Samples
Bacterial load was detected by quantitative culture from nasopharyngeal swab samples for S. pneumoniae, H. influenzae and M. catarrhalis and expressed in colony-forming unit/ milliliter (cfu/mL). Quantitative bacterial identification was used to indicate the presence of bacterial pathogen load >10^4 cfu/mL if present alone or > 10^5 cfu/mL if present as co-infection.
Measured: From Day 0 up to Year 2
Bacterial Load Detected (log10 Transformation) by Molecular Techniques (PCR) From Nasopharyngeal Swab Samples
Bacterial load was detected by quantitative molecular techniques from nasopharyngeal swab samples for S. pneumoniae, H. influenzae and M. catarrhalis and expressed in colony-forming unit/milliliter (cfu/mL). Quantitative bacterial identification was used to indicate the presence of bacterial pathogen load >10^4 cfu/mL if present alone or > 10^5 cfu/mL if present as co-infection.
Measured: From Day 0 and up to Year 2
Number of Subjects With Other Bacterial Pathogens Detected by Qualitative Culture From Nasopharyngeal Swab Samples
Bacterial pathogens were detected by qualitative culture from nasopharyngeal swab samples and included: Staphylococcus aureus and Stenotrophomonas maltophilia
Measured: From Day 0 and up to Year 2
Number of Qualitative Positive Unique Isolates of Subjects With S. Pneumoniae Serogroups and Serotypes in BAL Fluid Samples
Two isolates of S.p., H.i. and M.c. were selected per specimen type per subjects. For analyses, the 2 isolates were compared to determine if they were clones vs. different ("unique") pathogen. Isolates were considered "unique" based on the comparison of serotype and antibiotic susceptibility (AS) profile for S.p. and H.i. and on the AS profile alone for M.c.. If the 2 isolates had different serotypes, or the same serotype but a different AS profile, then the 2 isolates were considered "unique", and both isolates were retained in the analyses. S.p. serogoups and serotypes isolates included: 3, 6B, 7C, 10A, 11A, 11D, 12F, 14, 15B, 16F, 18C, 18F, 19A, 19F, 21, 22F, 23A, 23B, 31, 35F, 42, 48, NT (not typeable), Synflorix serotypes (1, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) and Pneumococcal conjugate vaccine (PCV) 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F). Note: For one subject who underwent BAL procedure, no BALF was available for study analyses.
Measured: From Day 0 to Year 2
Number of Qualitative Positive Unique Isolates of Subjects With H. Influenzae Typing Results From BAL Fluid Samples
The H. influenzae typing results included "f" and "NT" (not typeable). Unique isolate definition: 2 isolates of S.p., H.i. and M.c. were selected per specimen type per subjects. For analyses, the 2 isolates were compared to determine if they were clones vs. different ("unique") pathogen. Isolates were considered "unique" based on the comparison of serotype and antibiotic susceptibility (AS) profile for S.p. and H.i. and on the AS profile alone for M.c.. If the 2 isolates had different serotypes, or the same serotype but a different AS profile, then the 2 isolates were considered "unique", and both isolates were retained in the analyses.
Note: For one subject who underwent BAL procedure, no BALF was available for study analyses.
Measured: From Day 0 to Year 2
Number of Qualitative Positive Unique Isolates of Subjects With S. Pneumoniae Serogroups and Serotypes From Nasopharyngeal Swab Samples
- pneumoniae serogoups and serotypes included: 3, 6A, 6B, 7C, 9N, 10A, 11A, 11D, 12B, 12F, 14, 16F, 18C, 18F, 19A, 19C, 19F, 21, 23A, 23B, 31, 35A, 35F, 42, 48, NT (not typeable), Synflorix serotypes (1, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) and Pneumococcal conjugate vaccine (PCV) 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F).
Unique isolate definition: 2 isolates of S.p., H.i. and M.c. were selected per specimen type per subjects. For analyses, the 2 isolates were compared to determine if they were clones vs. different ("unique") pathogen. Isolates were considered "unique" based on the comparison of serotype and antibiotic susceptibility (AS) profile for S.p. and H.i. and on the AS profile alone for M.c.. If the 2 isolates had different serotypes, or the same serotype but a different AS profile, then the 2 isolates were considered "unique", and both isolates were retained in the analyses.
Measured: From Day 0 to Year 2
Number of Qualitative Positive Unique Isolates of Subjects With H. Influenzae Typing Results From Nasopharyngeal Swab Samples
The H. influenzae typing results include "f " and "NT" (not typeable). Unique isolate definition: 2 isolates of S.p., H.i. and M.c. were selected per specimen type per subjects. For analyses, the 2 isolates were compared to determine if they were clones vs. different ("unique") pathogen. Isolates were considered "unique" based on the comparison of serotype and antibiotic susceptibility (AS) profile for S.p. and H.i. and on the AS profile alone for M.c.. If the 2 isolates had different serotypes, or the same serotype but a different AS profile, then the 2 isolates were considered "unique", and both isolates were retained in the analyses.
Measured: From Day 0 to Year 2
Number of S. Pneumoniae Unique Isolates With Antimicrobial Susceptibility Response, Among Qualitative Positive Subjects
Antibiotic response of S.pneumoniae was susceptible (Sus), or intermediate (Int), or resistant (Res)(following Clinical and Laboratory Standards Institute [CLSI] guidelines [CLSI, 2015]) towards the tested antibiotics which included: Penicilin, Amoxicillin/Clavulanate, Erythromycin, Azithromycin, Tetracycline, Levofloxacin, Trimethoprim/Sulfamethoxazole.
Samples assessed were BAL fluid (BALF) samples and Nasopharyngeal swab (NPS) samples.
For the "Unique isolate definition", please refer to the previous outcome description.
Note: For one subject who underwent BAL procedure, no BAL fluid was available for study analyses.
Measured: From Day 0 to Year 2
Number of H. Influenzae Unique Isolates With Antimicrobial Susceptibility Response, Among Qualitative Positive Subjects
Antibiotic response of H.ifluenzae was susceptible (Sus), or intermediate (Int), or resistant (Res)(following Clinical and Laboratory Standards Institute [CLSI] guidelines [CLSI, 2015]) towards the tested antibiotics which included: Amoxicillin/Clavulanate, Azithromycin, Tetracycline, Levofloxacin, Trimethoprim/Sulfamethoxazole.
Samples assessed were BAL fluid (BALF) samples and Nasopharyngeal swab (NPS) samples.
For the "Unique isolate definition", please refer to the previous outcomes description.
Note: For one subject who underwent BAL procedure, no BAL fluid was available for study analyses.
Measured: From Day 0 to Year 2
Descriptive Statistics of the Antimicrobial Susceptibility Response of H. Influenzae for Unique Isolates Among Qualitative Positive Subjects, for Penicilin and Erythromycin
Antibiotic response of H. influenzae was tested against antibiotics which included: Penicilin and Erythromycin (following Clinical and Laboratory Standards Institute [CLSI] guidelines [CLSI, 2015]).
Samples assessed were BAL fluid (BALF) samples and Nasopharyngeal swab (NPS) samples.
Unique isolate definition: 2 isolates of S.p., H.i. and M.c. were selected per specimen type per subjects. For analyses, the 2 isolates were compared to determine if they were clones vs. different ("unique") pathogen. Isolates were considered "unique" based on the comparison of serotype and antibiotic susceptibility (AS) profile for S.p. and H.i. and on the AS profile alone for M.c.. If the 2 isolates had different serotypes, or the same serotype but a different AS profile, then the 2 isolates were considered "unique", and both isolates were retained in the analyses.
Note: For one subject who underwent BAL procedure, no BAL fluid was available for study analyses.
Measured: From Day 0 to Year 2
Number of M. Catarrhalis Unique Isolates With Antimicrobial Susceptibility Response, Among Qualitative Positive Subjects
Antibiotic response of M. catarrhalis was susceptible (Sus), or intermediate (Int), or resistant (Res)(following Clinical and Laboratory Standards Institute [CLSI] guidelines [CLSI, 2015]) towards the tested antibiotics which included: Amoxicillin/Clavulanate, Erythromycin, Azithromycin, Tetracycline, Levofloxacin, Trimethoprim/Sulfamethoxazole.
Samples assessed were BAL fluid (BALF) samples and Nasopharyngeal swab (NPS) samples.
For the "Unique isolate definition", please refer to the previous outcome description.
Note: For one subject who underwent BAL procedure, no BAL fluid was available for study analyses.
Measured: From Day 0 to Year 2
Descriptive Statistics of the Antimicrobial Susceptibility Response of M. Catarrhalis for Unique Isolates Among Qualitative Positive Subjects, for Penicilin
Antibiotic response of M. catarrhalis was tested against antibiotics which included: Penicilin.
Samples assessed were BAL fluid (BALF) samples and Nasopharyngeal swab (NPS) samples.
Unique isolate definition: 2 isolates of S.p., H.i. and M.c. were selected per specimen type per subjects. For analyses, the 2 isolates were compared to determine if they were clones vs. different ("unique") pathogen. Isolates were considered "unique" based on the comparison of serotype and antibiotic susceptibility (AS) profile for S.p. and H.i. and on the AS profile alone for M.c.. If the 2 isolates had different serotypes, or the same serotype but a different AS profile, then the 2 isolates were considered "unique", and both isolates were retained in the analyses.
Note: For one subject who underwent BAL procedure, no BAL fluid was available for study analyses.
Measured: From Day 0 to Year 2
Number of H. Influenzae or M. Catarrhalis Unique Isolates With Antimicrobial Susceptibility Positive Response Among Qualitative Positive Siubjects for Beta-lactamase
Antimicrobial response of H. influenzae and M. catarrhalis was tested for Beta-lactamase (following Clinical and Laboratory Standards Institute [CLSI] guidelines [CLSI, 2015]).
Samples assessed were BAL fluid (BALF) samples and Nasopharyngeal swab (NPS) samples.
Unique isolate definition: 2 isolates of S.p., H.i. and M.c. were selected per specimen type per subjects. For analyses, the 2 isolates were compared to determine if they were clones vs. different ("unique") pathogen. Isolates were considered "unique" based on the comparison of serotype and antibiotic susceptibility (AS) profile for S.p. and H.i. and on the AS profile alone for M.c.. If the 2 isolates had different serotypes, or the same serotype but a different AS profile, then the 2 isolates were considered "unique", and both isolates were retained in the analyses.
Note: For one subject who underwent BAL procedure, no BAL fluid was available for study analyses.
Measured: From Day 0 to Year 2
Number of S. Pneumoniae Unique Isolates With Antimicrobial Susceptibility Response From Quantitative Positive Subjects
Antibiotic response of S.pneumoniae was susceptible (Sus), or intermediate (Int), or resistant (Res)(following Clinical and Laboratory Standards Institute [CLSI] guidelines [CLSI, 2015]) towards the tested antibiotics which included: Penicilin, Amoxicillin/Clavulanate, Erythromycin, Azithromycin, Tetracycline, Levofloxacin, Trimethoprim/Sulfamethoxazole.
Samples assessed were BAL fluid (BALF) samples and Nasopharyngeal swab (NPS) samples.
For the "Unique isolate definition", please refer to the previous outcome description.
Note: For one subject who underwent BAL procedure, no BAL fluid was available for study analyses.
Measured: From Day 0 to Year 2
Number of H. Influenzae Unique Isolates With Antimicrobial Susceptibility Response From Quantitative Positive Subjects
Antibiotic response of H.ifluenzae was susceptible (Sus), or intermediate (Int), or resistant (Res)(following Clinical and Laboratory Standards Institute [CLSI] guidelines [CLSI, 2015])towards the tested antibiotics which included: Amoxicillin/Clavulanate, Azithromycin, Tetracycline, Levofloxacin, Trimethoprim/Sulfamethoxazole.
Samples assessed were BAL fluid (BALF) samples and Nasopharyngeal swab (NPS) samples.
For the "Unique isolate definition", please refer to the previous outcomes description.
Note: For one subject who underwent BAL procedure, no BAL fluid was available for study analyses.
Measured: From Day 0 to Year 2
Descriptive Statistics of the Antimicrobial Susceptibility Response of H.Influenzae for Unique Isolates Among Quantitative Positive Subjects, for Penicilin and Erythromycin
Antibiotic response of H.ifluenzae was tested against antibiotics which included: Penicilin and Erythromycin (following Clinical and Laboratory Standards Institute [CLSI] guidelines [CLSI, 2015]).
Samples assessed were BAL fluid (BALF) samples and Nasopharyngeal swab (NPS) samples.
Unique isolate definition: 2 isolates of S.p., H.i. and M.c. were selected per specimen type per subjects. For analyses, the 2 isolates were compared to determine if they were clones vs. different ("unique") pathogen. Isolates were considered "unique" based on the comparison of serotype and antibiotic susceptibility (AS) profile for S.p. and H.i. and on the AS profile alone for M.c.. If the 2 isolates had different serotypes, or the same serotype but a different AS profile, then the 2 isolates were considered "unique", and both isolates were retained in the analyses.
Note: For one subject who underwent BAL procedure, no BAL fluid was available for study analyses.
Measured: From Day 0 to Year 2
Number of M. Catarrhalis Unique Isolates With Antimicrobial Susceptibility Response From Quantitative Positive Subjects
Antibiotic response of M. catarrhalis was susceptible (Sus.), or intermediate (Int.), or resistant (Res.)(following Clinical and Laboratory Standards Institute [CLSI] guidelines [CLSI, 2015]) towards the tested antibiotics which included: Amoxicillin/Clavulanate, Erythromycin, Azithromycin, Tetracycline, Levofloxacin, Trimethoprim/Sulfamethoxazole.
Samples assessed were BAL fluid (BALF) samples and Nasopharyngeal swab (NPS) samples.
For the "Unique isolate definition", please refer to the previous outcome description.
Note: For one subject who underwent BAL procedure, no BAL fluid was available for study analyses.
Measured: From Day 0 to Year 2
Descriptive Statistics of the Antimicrobial Susceptibility Response of M. Catarrhalis for Unique Isolates Among Quantitative Positive Subjects, for Penicilin
Antibiotic response of M. catarrhalis was tested against antibiotics which included: Penicilin (following Clinical and Laboratory Standards Institute [CLSI] guidelines [CLSI, 2015]).
Samples assessed were BAL fluid (BALF) samples and Nasopharyngeal swab (NPS) samples.
Unique isolate definition: 2 isolates of S.p., H.i. and M.c. were selected per specimen type per subjects. For analyses, the 2 isolates were compared to determine if they were clones vs. different ("unique") pathogen. Isolates were considered "unique" based on the comparison of serotype and antibiotic susceptibility (AS) profile for S.p. and H.i. and on the AS profile alone for M.c.. If the 2 isolates had different serotypes, or the same serotype but a different AS profile, then the 2 isolates were considered "unique", and both isolates were retained in the analyses.
Note: For one subject who underwent BAL procedure, no BAL fluid was available for study analyses.
Measured: From Day 0 to Year 2
Number of H. Influenzae and M. Catarrhalis Unique Isolates With Antimicrobial Susceptibility Positive Response From Quantitative Positive Subjects, for Beta-lactamase
Antimicrobial response of H. influenzae and M. catarrhalis was tested for Beta-lactamase (following Clinical and Laboratory Standards Institute [CLSI] guidelines [CLSI, 2015]).
Samples assessed were BAL fluid (BALF) samples and Nasopharyngeal swab (NPS) samples.
Unique isolate definition: 2 isolates of S.p., H.i. and M.c. were selected per specimen type per subjects. For analyses, the 2 isolates were compared to determine if they were clones vs. different ("unique") pathogen. Isolates were considered "unique" based on the comparison of serotype and antibiotic susceptibility (AS) profile for S.p. and H.i. and on the AS profile alone for M.c.. If the 2 isolates had different serotypes, or the same serotype but a different AS profile, then the 2 isolates were considered "unique", and both isolates were retained in the analyses.
Note: For one subject who underwent BAL procedure, no BAL fluid was available for study analyses.
Measured: From Day 0 to Year 2
Mean Age of Subjects
Demographic characteristics included age, which was expressed in months.
Measured: From Day 0 to Year 2
Subject Gender
Demographic characteristics included gender: female and male.
Measured: From Day 0 to Year 2
Mean Weight of Subjects
Demographic characteristics included weight which was expressed in kilograms (kg).
Measured: From Day 0 to Year 2
Mean Height of Subjects
Demographic characteristics included height which was expressed in centimeters (cm).
Measured: From Day 0 to Year 2
Number of Subjects With Body Mass Index (BMI) Characteristics
Demographic characteristics included body mass index (BMI) whose z-scores were measures of relative weight adjusted for child age and sex.
Measured: From Day 0 to Year 2
Number of Subjects Presenting General Medical History Characteristics
General medical history characteristics included: any pre-existing conditions, congenital chromosomal abnormality, prematurity (less than 37 weeks) neonatal problems, chronic renal failure, immune system disorder (including auto-immune), atopic dermatitis, clinician-confirmed eczema, asthma and other.
Measured: From Day 0 to Year 2
Mean Gestational Age of Subjects
General medical history included mean gestational age.
Measured: From Day 0 to Year 2
Number of Subjects With Pneumococcal Vaccination History Characteristics
Pneumococcal vaccination history characteristics included vaccination, pneumococcal vaccines received (Prevnar only, Prevnar 13 only, Synflorix only, Mix of vaccines), Prevnar only doses (1-4), Prevnar 13 only doses (1-4), Synflorix only doses (4), medical history source validated or not.
Measured: From Day 0 to Year 2
Number of Subjects With Flu Vaccination History Characteristics
Flu vaccination history included vaccination, Flu vaccine doses (1-5), medical history source validated or not.
Measured: From Day 0 to Year 2
Number of Subjects With Haemophilus Influenzae Type b Vaccination History Characteristics
Haemophilus influenzae type b vaccination history included vaccination, Haemophilus influenzae type b vaccine doses (1-4), medical history source validated or not.
Measured: From Day 0 to Year 2
Number of Subjects With Antibiotics and Other Medications Administered
Medication history referred to antibiotics administered in the past 6 months, drug names, antibiotic information source, other medications administered during the past 6 months, information source.
Measured: From Day 0 to Year 2
Number of Subjects With Clinical Characteristics
Clinical characteristics included affections/pre-conditions, affection episodes, number of children living in a household, children in day-care centres, exposure to cigarette smoke.
Measured: From Day 0 to Year 2
Number of Subjects With Laboratory Results
Laboratory results included blood sample results available, white blood Cell (WBC) count analysed, WBC reference range, Clinically relevant to the suspected chronic lower respiratory tract infection (LRTI) in the child if out of the range of WBC [LRTI-WBC], CRP (C-reactive protein) reference range, CRP groups, Clinically relevant to the suspected chronic LRTI in the child if out of the range of CRP [LRTI-CRP], ESR (Erythrocyte sedimentation rate) analysed, ESR reference range and Clinically relevant to the suspected chronic LRTI in the child if out of the range of ESR [LRTI-ESR].
Measured: From Day 0 to Year 2
White Blood Cells (WBC) Laboratory Results
Laboratory results for WBC were expressed in 10^9 cells per liter (10^9 cells/L).
Measured: From Day 0 to Year 2
C-reactive Protein (CRP) Laboratory Results
Laboratory results for CRP were expressed in milligrams per litre (mg/L).
Measured: From Day 0 to Year 2
Erythrocyte Sedimentation Rate (ESR) Laboratory Results
Laboratory results for ESR were expressed in millimeters per hour (mm/hr).
Measured: From Day 0 to Year 2
Number of Subjects With Radiological Results
Radiological results included x-ray, result normality, relationship of abnormality to BAL sampling.
Measured: From Day 0 to Year 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2016 (estimated)
- Study start23 Sep 2013
- Primary completion23 Sep 2015
- Study completion23 Sep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Infections, StreptococcalStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 197 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02838407
- Sponsor's protocol ID
- 115813
- Status last verified
- Sep 2019
- First submitted
- 8 Jul 2016
- Last updated
- 4 Oct 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Individual data sharing
- No
Publications
Escribano Montaner A, Garcia de Lomas J, Villa Asensi JR, Asensio de la Cruz O, de la Serna Blazquez O, Santiago Burruchaga M, Mondejar Lopez P, Torrent Vernetta A, Feng Y, Van Dyke MK, Reyes J, Garcia-Corbeira P, Talarico CA; EPI-Strep-064 study group. Bacteria from bronchoalveolar lavage fluid from children with suspected chronic lower respiratory tract infection: results from a multi-center, cross-sectional study in Spain. Eur J Pediatr. 2018 Feb;177(2):181-192. doi: 10.1007/s00431-017-3044-3. Epub 2017 Dec 29.
PubMed 29285648
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification and Characterization of Bacteria in the Lower Airways of Children Aged ≥ 6 Months to < 6 Years With Suspected Lower Respiratory Tract Infections (LRTI) in Spain.
- ClinicalTrials.gov ID
- NCT02838407
- Acronym / sponsor ID
- 115813
- Conditions
- Infections, Streptococcal
- Keywords
- Chronic lower respiratory tract infection, Bonchoalveolar lavage, Nasopharyngeal swabs
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 197 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 23 Sep 2013 (actual)
- Primary completion
- 23 Sep 2015 (actual)
- Study completion
- 23 Sep 2015 (actual)
- First posted
- 20 Jul 2016 (estimated)
- Results
- Posted 4 Oct 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to identify and characterise bacteria present in the lower airways of children with suspected chronic LRTIs and for whom bronchoalveolar lavage (BAL) is indicated by the clinician.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Total group | Other | Other: BAL fluid sampling, Other: Nasopharyngeal swab samplingAll enrolled subjects, male or female aged between 6 months included and less than 6 years at the time of enrollment, who visited the hospital with suspected chronic lower respiratory tract infections (LRTIs) and who had an indication for bronchoalveolar lavage (BAL). |
Who may qualify
- Ages
- 6 months to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Subjects who the investigator believes that parent(s)/ legally acceptable representatives (LAR[s]) can and will comply with the requirements of the protocol.
- A male or female subject aged ≥ 6 months to < 6 years at the time of enrolment.
- Subjects meet the case definition of suspected chronic LRTIs where BAL is indicated.
- Subject's parent(s)/ LAR(s) agree to the collection of a nasopharyngeal swab from the subject.
- Written informed consent obtained from the parent(s)/ LAR(s) of the subject.
Key exclusion criteria (6 listed)
- Known cystic fibrosis, immunosuppression, or other severe immunodeficiencies such as agammaglobu-linaemia, T cell deficiency or Human Immunodeficiency Virus/ Acquired Immune Deficiency Syndrome, chemotherapy treatment, etc.
- Exacerbation of persistent respiratory symptoms (cough, wheezing, difficulty in breathing, etc.) in the previous 2 weeks.
- Antibiotic treatment in the 2 weeks prior to study entry.
- Concurrent participation in another study within 30 days prior to study entry or at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).
- Subjects having previously participated in this study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BAL fluid samplingFollowing routine BAL procedures at the hospital, collection of BAL fluid samples: at least 2 mL, at Day 0. | Other | Total group |
| Nasopharyngeal swab sampling1 swab, Day 0 | Other | Total group |
Primary outcome
Number of Subjects With Bacterial Aetiology, Assessed by Culture Growth, From Bronchoalveolar Lavage (BAL) Fluid Samples
Time frame: From Day 0 up to Year 2
Bacterial aetiology was assessed by culture growth from BAL fluid sample for Steptococcus pneumoniae (S.p.), Haemophilus influenzae (H.i.) and Moraxella catarrhalis (M.c.) , through either qualitative or quantitative bacterial identification (B.I.). The categories assessed were: positive (Pos.), negative (Neg.) and Missing (Mis.). For quantitative bacterial identification, S.p., H.i. and M.c. were confirmed by bacterial identification load higher than (>) 10^4 colony forming units per milliliter (cfu/mL), if bacterial species were present alone, or >10^5 cfu/mL if present as co-infection. Note: For one subject who underwent BAL procedure, no BAL fluid was available for study analyses.
Number of Subjects With Bacterial Aetiology Characteristics in BAL Fluid Samples
Time frame: From Day 0 up to Year 2
S. pneumoniae (S.p.), H. influenzae (H.i.) and M. catarrhalis (M.c.) were confirmed by bacterial identification (B.I.) load higher than (>) 10^4 colony forming units per milliliter (cfu/mL), if bacterial species were present alone, or >10^5 cfu/mL if presented as co-infection. Analysis was also performed for other bacterial pathogens alone or as co-infection. Note: For one subject who underwent BAL procedure, no BAL fluid was available for study analyses
Number of Subjects With Bacterial Identification >10^4 Cfu/mL in BAL Fluid Samples (S. Pneumoniae and H. Influenzae Results for the "Negative M. Catarrhalis" BAL Fluid Samples Results Category)
Time frame: From Day 0 up to Year 2
S. pneumoniae, H. influenzae and M. catarrhalis were confirmed by bacterial identification load higher than (>) 10^4 colony forming units per milliliter (cfu/mL), if bacterial species were present alone. Bacterial load referred to Negative M. catarrhalis - Negative S. pneumoniae - Negative H. influenzae (N.M.c.-N.S.p.-N.H.i.), Negative M. catarrhalis - Negative S. pneumoniae - Positive H. influenzae (N.M.c.-N.S.p.-P.H.i.), Negative M. catarrhalis - Positive S. pneumoniae - Negative H. influenzae (N.M.c.-P.S.p.-N.H.i.), Negative M. catarrhalis - Positive S. pneumoniae - Positive H. influenzae (N.M.c.-P.S.p.-P..H.i.). Notes: bacterial identification for the N.M.c.-P.S.p.-P.H.i. category was confirmed as a co-infection with a bacterial load >10^5 cfu/mL. For one subject who underwent BAL procedure, no BAL fluid was available for study analyses.
Number of Subjects With Bacterial Identification >10^4 Cfu/mL in BAL Fluid Samples (S. Pneumoniae and H. Influenzae Results for the "Positive M. Catarrhalis" BAL Fluid Samples Results Category)
Time frame: From Day 0 up to Year 2
S. pneumoniae, H. influenzae and M. catarrhalis were confirmed by bacterial identification load higher than (>) 10^4 colony forming units per milliliter (cfu/mL), if bacterial species were present alone and by bacterial load >10^5 cfu/mL if presented as co-infection. Categories referred to Positive M. catarrhalis -Negative S. pneumoniae - Negative H. influenzae (P.M.c.-N.S.p.-N.H.i.), Positive M. catarrhalis -Negative S. pneumoniae - Positive H. influenzae (P.M.c.-N.S.p.-P.H.i.), Positive M. catarrhalis - Positive S. pneumoniae - Negative H. influenzae (P.M.c.-P.S.p.-N.H.i.), Positive M. catarrhalis - Positive S. pneumoniae - Positive H. influenzae (P.M.c.-P.S.p.-P.H.i.). Notes: bacterial identification for the P.M.c.-N.S.p.-P.H.i., P.M.c.-P.S.p.-N.H.i. and P.M.c.-P.S.p.-P.H.i. categories was confirmed by a bacterial identification >10^5 cfu/mL. For one subject who underwent BAL procedure, no BAL fluid was available for study analyses
40 secondary outcomes
Number of Subjects With Bacterial Colonization, Assessed by Culture Growth, From Nasopharyngeal Swab Samples
Time frame: From Day 0 up to Year 2
Bacterial Load Detected (log10 Transformation) by Quantitative Culture Growth, From BAL Fluid Samples
Time frame: From Day 0 up to Year 2
Bacterial Load Detected (log10 Transformation) by Quantitative Molecular Techniques (Polymerase Chain Reaction) From BAL Fluid Samples
Time frame: From Day 0 up to Year 2
Number of Subjects With Other Bacterial Pathogens Detected by Qualitative Culture, From BAL Fluid Samples
Time frame: From Day 0 up to Year 2
Bacterial Load Detected (log10 Transformation) by Quantitative Culture From Nasopharyngeal Swab Samples
Time frame: From Day 0 up to Year 2
Bacterial Load Detected (log10 Transformation) by Molecular Techniques (PCR) From Nasopharyngeal Swab Samples
Time frame: From Day 0 and up to Year 2
Number of Subjects With Other Bacterial Pathogens Detected by Qualitative Culture From Nasopharyngeal Swab Samples
Time frame: From Day 0 and up to Year 2
Number of Qualitative Positive Unique Isolates of Subjects With S. Pneumoniae Serogroups and Serotypes in BAL Fluid Samples
Time frame: From Day 0 to Year 2
Number of Qualitative Positive Unique Isolates of Subjects With H. Influenzae Typing Results From BAL Fluid Samples
Time frame: From Day 0 to Year 2
Number of Qualitative Positive Unique Isolates of Subjects With S. Pneumoniae Serogroups and Serotypes From Nasopharyngeal Swab Samples
Time frame: From Day 0 to Year 2
Number of Qualitative Positive Unique Isolates of Subjects With H. Influenzae Typing Results From Nasopharyngeal Swab Samples
Time frame: From Day 0 to Year 2
Number of S. Pneumoniae Unique Isolates With Antimicrobial Susceptibility Response, Among Qualitative Positive Subjects
Time frame: From Day 0 to Year 2
Number of H. Influenzae Unique Isolates With Antimicrobial Susceptibility Response, Among Qualitative Positive Subjects
Time frame: From Day 0 to Year 2
Descriptive Statistics of the Antimicrobial Susceptibility Response of H. Influenzae for Unique Isolates Among Qualitative Positive Subjects, for Penicilin and Erythromycin
Time frame: From Day 0 to Year 2
Number of M. Catarrhalis Unique Isolates With Antimicrobial Susceptibility Response, Among Qualitative Positive Subjects
Time frame: From Day 0 to Year 2
Descriptive Statistics of the Antimicrobial Susceptibility Response of M. Catarrhalis for Unique Isolates Among Qualitative Positive Subjects, for Penicilin
Time frame: From Day 0 to Year 2
Number of H. Influenzae or M. Catarrhalis Unique Isolates With Antimicrobial Susceptibility Positive Response Among Qualitative Positive Siubjects for Beta-lactamase
Time frame: From Day 0 to Year 2
Number of S. Pneumoniae Unique Isolates With Antimicrobial Susceptibility Response From Quantitative Positive Subjects
Time frame: From Day 0 to Year 2
Number of H. Influenzae Unique Isolates With Antimicrobial Susceptibility Response From Quantitative Positive Subjects
Time frame: From Day 0 to Year 2
Descriptive Statistics of the Antimicrobial Susceptibility Response of H.Influenzae for Unique Isolates Among Quantitative Positive Subjects, for Penicilin and Erythromycin
Time frame: From Day 0 to Year 2
Number of M. Catarrhalis Unique Isolates With Antimicrobial Susceptibility Response From Quantitative Positive Subjects
Time frame: From Day 0 to Year 2
Descriptive Statistics of the Antimicrobial Susceptibility Response of M. Catarrhalis for Unique Isolates Among Quantitative Positive Subjects, for Penicilin
Time frame: From Day 0 to Year 2
Number of H. Influenzae and M. Catarrhalis Unique Isolates With Antimicrobial Susceptibility Positive Response From Quantitative Positive Subjects, for Beta-lactamase
Time frame: From Day 0 to Year 2
Mean Age of Subjects
Time frame: From Day 0 to Year 2
Subject Gender
Time frame: From Day 0 to Year 2
Mean Weight of Subjects
Time frame: From Day 0 to Year 2
Mean Height of Subjects
Time frame: From Day 0 to Year 2
Number of Subjects With Body Mass Index (BMI) Characteristics
Time frame: From Day 0 to Year 2
Number of Subjects Presenting General Medical History Characteristics
Time frame: From Day 0 to Year 2
Mean Gestational Age of Subjects
Time frame: From Day 0 to Year 2
Number of Subjects With Pneumococcal Vaccination History Characteristics
Time frame: From Day 0 to Year 2
Number of Subjects With Flu Vaccination History Characteristics
Time frame: From Day 0 to Year 2
Number of Subjects With Haemophilus Influenzae Type b Vaccination History Characteristics
Time frame: From Day 0 to Year 2
Number of Subjects With Antibiotics and Other Medications Administered
Time frame: From Day 0 to Year 2
Number of Subjects With Clinical Characteristics
Time frame: From Day 0 to Year 2
Number of Subjects With Laboratory Results
Time frame: From Day 0 to Year 2
White Blood Cells (WBC) Laboratory Results
Time frame: From Day 0 to Year 2
C-reactive Protein (CRP) Laboratory Results
Time frame: From Day 0 to Year 2
Erythrocyte Sedimentation Rate (ESR) Laboratory Results
Time frame: From Day 0 to Year 2
Number of Subjects With Radiological Results
Time frame: From Day 0 to Year 2
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 29285648Escribano Montaner A, Garcia de Lomas J, Villa Asensi JR, Asensio de la Cruz O, de la Serna Blazquez O, Santiago Burruchaga M, Mondejar Lopez P, Torrent Vernetta A, Feng Y, Van Dyke MK, Reyes J, Garcia-Corbeira P, Talarico CA; EPI-Strep-064 study group. Bacteria from bronchoalveolar lavage fluid from children with suspected chronic lower respiratory tract infection: results from a multi-center, cross-sectional study in Spain. Eur J Pediatr. 2018 Feb;177(2):181-192. doi: 10.1007/s00431-017-3044-3. Epub 2017 Dec 29.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BAL fluid sampling and Nasopharyngeal swab sampling in people with Infections, Streptococcal, run by GlaxoSmithKline at 7 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Oct 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Subjects With Bacterial Aetiology, Assessed by Culture Growth, From Bronchoalveolar Lavage (BAL) Fluid Samples (time frame: From Day 0 up to Year 2). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02838407, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2019.