Infections, Respiratory TractNCT01292213
A Study to Identify and Characterise Bacteria Causing Chronic Cough Among Children in United Kingdom
An observational study of Infections, Respiratory Tract, run by GlaxoSmithKline at 3 sites in United Kingdom.
Trial summary
The purpose of this study is to investigate the role of Haemophilus influenzae and other bacteria in causing chronic cough, through a direct comparison of chronic cough cases and healthy controls recruited from paediatric respiratory clinics in the United Kingdom. Read more about this study
- Who is it for?
- Ages 6 to 72 months
- Conditions the study is for
- Infections, Respiratory Tract
- What is being tested?
- Cough swab, Oropharyngeal swab and Nasopharyngeal swabs
- Type of treatment
- Surgery or procedure
- How many people
- 19 participants
- Where
- 3 sitesUnited Kingdom
- Study dates
- May 2012to Feb 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 72 months
- All sexes
- No healthy volunteers
- Child
Study population: Children aged six to 72 months, residing in the United Kingdom. These children will be classified as cases and controls. Cases will be children who have had persistent cough for greater than eight weeks and are undergoing general anaesthesia for clinically indicated bronchoscopy/ bronchoalveolar lavage as part of the diagnostic process for chronic cough. Controls will be children who are undergoing general anaesthesia with endotracheal intubation for elective surgery or endoscopy for non-respiratory-related conditions and had no acute or chronic respiratory symptoms during the four weeks prior to the visit.
Who may be able to join
- Subjects who the investigator believes that parent(s)/ legally acceptable representative can and will comply with the requirements of the protocol.
- A male or female child between, and including, six to 72 months of age at the time of enrolment.
- Written informed consent obtained from the parent(s)/ legally acceptable representative of the subject.
- No antibiotic therapy within four weeks prior to the visit.
- No cystic fibrosis or known major immunodeficiency such as agammaglobulinaemia, T cell deficiency or Human Immunodeficiency Virus / Acquired Immune Deficiency Syndrome.
- No documented evidence or suspicion of gastroesophageal reflux disease.
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- No evidence of an upper viral respiratory infection four weeks prior to the visit.
- In addition, all subjects regarded as 'cases' must satisfy all the following criteria at study entry:
- Persistent cough greater than eight weeks.
- No response to five-day prednisolone treatment.
- Chest X-ray showing no evidence of a lobar pneumonia or gross structural abnormality.
- In addition, all subjects regarded as 'controls' must satisfy the following criteria at study entry:
- No respiratory symptoms four weeks prior to the visit.
- No documented evidence or suspicion of lung disease upon physical examination.
Who cannot join
- Concurrently participating in another study, 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.
- Use of any investigational or non-registered product within 30 days prior to study procedures, or planned use during the study period.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
- Child in care.
Trial locations and contacts
3 sites in 1 country.
United Kingdom3 sites
GSK Investigational Site
Belfast, BT12 6BE
GSK Investigational Site
Bristol, BS2 8AE
GSK Investigational Site
Sheffield, S10 2TH
About this study
Official title: Identification and Characterisation of Bacteria Causing Chronic Cough Among Children in the United Kingdom
The purpose of this study is to investigate the role of Haemophilus influenzae and other bacteria in causing chronic cough, through a direct comparison of chronic cough cases and healthy controls recruited from paediatric respiratory clinics in the United Kingdom.
- Conditions
- Infections, Respiratory Tract
- Being tested
- Cough swab, Oropharyngeal swab, Nasopharyngeal swabs, Blood sample, Bronchoscopy/ bronchoalveolar lavage samples
- Keywords
- Chronic cough, Haemophilus influenzae
- Medical subject headings
- Respiratory Tract Infections, Chronic Cough, Haemophilus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cough swabProcedure or surgery
Samples will be tested to determine and characterise the bacteria that may be associated with chronic cough.
Oropharyngeal swabProcedure or surgery
Samples will be tested to determine and characterise the bacteria that may be associated with chronic cough.
Nasopharyngeal swabsProcedure or surgery
Samples will be tested to determine and characterise the bacteria and viruses that may be associated with chronic cough.
Blood sampleProcedure or surgery
Samples will be tested to determine and characterise the immunological markers that may be associated with chronic cough.
Bronchoscopy/ bronchoalveolar lavage samplesProcedure or surgery
Samples will be tested to determine and characterise the bacteria, viruses and immunological markers that may be associated with chronic cough.
Data collectionOther
Questionnaire completion.
| Study group | Role | What they receive |
|---|---|---|
| Cases | Subjects diagnosed with chronic cough who are undergoing general anaesthesia and bronchoscopy/BAL as part of the diagnostic process for chronic cough. Receives: Procedure: Cough swab; Procedure: Oropharyngeal swab; Procedure: Nasopharyngeal swabs; Procedure: Blood sample; Procedure: Bronchoscopy/ bronchoalveolar lavage samples; Other: Data collection | |
| Controls | Subjects without respiratory symptoms who are undergoing general anaesthesia for elective surgery or endoscopy of non-respiratory-related conditions. Receives: Procedure: Cough swab; Procedure: Oropharyngeal swab; Procedure: Nasopharyngeal swabs; Procedure: Blood sample; Procedure: Bronchoscopy/ bronchoalveolar lavage samples; Other: Data collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of Haemophilus influenzae, in the absence of co-infection with other bacteria, in the lower airways of cases and controls
Measured: 12-15 months from study initiation
Secondary outcomes (20)
Occurrence of Haemophilus influenzae, regardless of co-infection with other bacteria, in the lower airways of cases and controls
Measured: 12-15 months from study initiation
Occurrence of Streptococcus pneumoniae in the lower airways of cases and controls
Measured: 12-15 months from study initiation
Occurrence of Haemophilus influenzae in cough swabs and nasopharynx/ oropharynx of cases and controls
Measured: 12-15 months from study initiation
Occurrence of Haemophilus influenzae in the lower airways and/or nasopharynx/ oropharynx of cases and controls
Measured: 12-15 months from study initiation
Bacterial load of Haemophilus influenzae in the lower airways and nasopharynx/ oropharynx of cases and controls
Measured: 12-15 months from study initiation
Occurrence of Haemophilus haemolyticus in the lower airways and nasopharynx/ oropharynx of cases and controls
Measured: 12-15 months from study initiation
Antimicrobial resistance of Haemophilus influenzae in lower airways
Measured: 12-15 months from study initiation
Occurrence of viral pathogens in the lower airways and nasopharynx of cases and controls
Measured: 12-15 months from study initiation
Occurrence of Moraxella catarrhalis in the lower airways of cases and controls
Measured: 12-15 months from study initiation
Occurrence of other bacterial pathogens in the lower airways of cases and controls
Measured: 12-15 months from study initiation
Occurrence of Streptococcus pneumoniae in cough swabs and nasopharynx/ oropharynx of cases and controls
Measured: 12-15 months from study initiation
Occurrence of Moraxella catarrhalis in cough swabs and nasopharynx/ oropharynx of cases and controls
Measured: 12-15 months from study initiation
Occurrence of Streptococcus pneumoniae in the lower airways and/or nasopharynx/ oropharynx of cases and controls
Measured: 12-15 months from study initiation
Occurrence of other bacterial pathogens in the lower airways and/or nasopharynx/ oropharynx of cases and controls
Measured: 12-15 months from study initiation
Bacterial load of Streptococcus pneumoniae in the lower airways and nasopharynx/ oropharynx of cases and controls
Measured: 12-15 months from study initiation
Bacterial load of Moraxella catarrhalis in the lower airways and nasopharynx/ oropharynx of cases and controls
Measured: 12-15 months from study initiation
Occurrence of serotypes of Haemophilus influenzae in the lower airways and nasopharynx/ oropharynx of cases and controls
Measured: 12-15 months from study initiation
Occurrence of serotypes of Streptococcus pneumoniae in the lower airways and nasopharynx/ oropharynx of cases and controls
Measured: 12-15 months from study initiation
Antimicrobial resistance of Streptococcus pneumoniae in lower airways
Measured: 12-15 months from study initiation
Antimicrobial resistance of Moraxella catarrhalis in lower airways
Measured: 12-15 months from study initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2011 (estimated)
- Study startMay 2012
- Primary completionFeb 2013
- Study completionFeb 2013
Why it stopped: • Long delay due to challenges with sample analysis at local labs; • Low recruitment of case and control subjects; • Constant staff turn-over in the sites.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infections, Respiratory TractStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 19 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
- NCT01292213
- Sponsor's protocol ID
- 112956
- Status last verified
- Sep 2014
- First submitted
- 3 Feb 2011
- Last updated
- 8 Sep 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification and Characterisation of Bacteria Causing Chronic Cough Among Children in the United Kingdom
- ClinicalTrials.gov ID
- NCT01292213
- Acronym / sponsor ID
- 112956
- Conditions
- Infections, Respiratory Tract
- Keywords
- Chronic cough, Haemophilus influenzae
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: • Long delay due to challenges with sample analysis at local labs; • Low recruitment of case and control subjects; • Constant staff turn-over in the sites.
- Enrolment
- 19 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- May 2012
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 9 Feb 2011 (estimated)
- Results
- Not posted in the source record
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 investigate the role of Haemophilus influenzae and other bacteria in causing chronic cough, through a direct comparison of chronic cough cases and healthy controls recruited from paediatric respiratory clinics in the United Kingdom.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cases | – | Procedure: Cough swab, Procedure: Oropharyngeal swab, Procedure: Nasopharyngeal swabs, Procedure: Blood sample, Procedure: Bronchoscopy/ bronchoalveolar lavage samples, Other: Data collectionSubjects diagnosed with chronic cough who are undergoing general anaesthesia and bronchoscopy/BAL as part of the diagnostic process for chronic cough. |
| Controls | – | Procedure: Cough swab, Procedure: Oropharyngeal swab, Procedure: Nasopharyngeal swabs, Procedure: Blood sample, Procedure: Bronchoscopy/ bronchoalveolar lavage samples, Other: Data collectionSubjects without respiratory symptoms who are undergoing general anaesthesia for elective surgery or endoscopy of non-respiratory-related conditions. |
Who may qualify
- Ages
- 6 to 72 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children aged six to 72 months, residing in the United Kingdom. These children will be classified as cases and controls. Cases will be children who have had persistent cough for greater than eight weeks and are undergoing general anaesthesia for clinically indicated bronchoscopy/ bronchoalveolar lavage as part of the diagnostic process for chronic cough. Controls will be children who are undergoing general anaesthesia with endotracheal intubation for elective surgery or endoscopy for non-respiratory-related conditions and had no acute or chronic respiratory symptoms during the four weeks prior to the visit.
Key inclusion criteria (14 listed)
- Subjects who the investigator believes that parent(s)/ legally acceptable representative can and will comply with the requirements of the protocol.
- A male or female child between, and including, six to 72 months of age at the time of enrolment.
- Written informed consent obtained from the parent(s)/ legally acceptable representative of the subject.
- No antibiotic therapy within four weeks prior to the visit.
- No cystic fibrosis or known major immunodeficiency such as agammaglobulinaemia, T cell deficiency or Human Immunodeficiency Virus / Acquired Immune Deficiency Syndrome.
Key exclusion criteria (4 listed)
- Concurrently participating in another study, 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.
- Use of any investigational or non-registered product within 30 days prior to study procedures, or planned use during the study period.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
- Child in care.
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 |
|---|---|---|
| Cough swabSamples will be tested to determine and characterise the bacteria that may be associated with chronic cough. | Procedure or surgery | Cases, Controls |
| Oropharyngeal swabSamples will be tested to determine and characterise the bacteria that may be associated with chronic cough. | Procedure or surgery | Cases, Controls |
| Nasopharyngeal swabsSamples will be tested to determine and characterise the bacteria and viruses that may be associated with chronic cough. | Procedure or surgery | Cases, Controls |
| Blood sampleSamples will be tested to determine and characterise the immunological markers that may be associated with chronic cough. | Procedure or surgery | Cases, Controls |
| Bronchoscopy/ bronchoalveolar lavage samplesSamples will be tested to determine and characterise the bacteria, viruses and immunological markers that may be associated with chronic cough. | Procedure or surgery | Cases, Controls |
| Data collectionQuestionnaire completion. | Other | Cases, Controls |
Primary outcome
Occurrence of Haemophilus influenzae, in the absence of co-infection with other bacteria, in the lower airways of cases and controls
Time frame: 12-15 months from study initiation
20 secondary outcomes
Occurrence of Haemophilus influenzae, regardless of co-infection with other bacteria, in the lower airways of cases and controls
Time frame: 12-15 months from study initiation
Occurrence of Streptococcus pneumoniae in the lower airways of cases and controls
Time frame: 12-15 months from study initiation
Occurrence of Haemophilus influenzae in cough swabs and nasopharynx/ oropharynx of cases and controls
Time frame: 12-15 months from study initiation
Occurrence of Haemophilus influenzae in the lower airways and/or nasopharynx/ oropharynx of cases and controls
Time frame: 12-15 months from study initiation
Bacterial load of Haemophilus influenzae in the lower airways and nasopharynx/ oropharynx of cases and controls
Time frame: 12-15 months from study initiation
Occurrence of Haemophilus haemolyticus in the lower airways and nasopharynx/ oropharynx of cases and controls
Time frame: 12-15 months from study initiation
Antimicrobial resistance of Haemophilus influenzae in lower airways
Time frame: 12-15 months from study initiation
Occurrence of viral pathogens in the lower airways and nasopharynx of cases and controls
Time frame: 12-15 months from study initiation
Occurrence of Moraxella catarrhalis in the lower airways of cases and controls
Time frame: 12-15 months from study initiation
Occurrence of other bacterial pathogens in the lower airways of cases and controls
Time frame: 12-15 months from study initiation
Occurrence of Streptococcus pneumoniae in cough swabs and nasopharynx/ oropharynx of cases and controls
Time frame: 12-15 months from study initiation
Occurrence of Moraxella catarrhalis in cough swabs and nasopharynx/ oropharynx of cases and controls
Time frame: 12-15 months from study initiation
Occurrence of Streptococcus pneumoniae in the lower airways and/or nasopharynx/ oropharynx of cases and controls
Time frame: 12-15 months from study initiation
Occurrence of other bacterial pathogens in the lower airways and/or nasopharynx/ oropharynx of cases and controls
Time frame: 12-15 months from study initiation
Bacterial load of Streptococcus pneumoniae in the lower airways and nasopharynx/ oropharynx of cases and controls
Time frame: 12-15 months from study initiation
Bacterial load of Moraxella catarrhalis in the lower airways and nasopharynx/ oropharynx of cases and controls
Time frame: 12-15 months from study initiation
Occurrence of serotypes of Haemophilus influenzae in the lower airways and nasopharynx/ oropharynx of cases and controls
Time frame: 12-15 months from study initiation
Occurrence of serotypes of Streptococcus pneumoniae in the lower airways and nasopharynx/ oropharynx of cases and controls
Time frame: 12-15 months from study initiation
Antimicrobial resistance of Streptococcus pneumoniae in lower airways
Time frame: 12-15 months from study initiation
Antimicrobial resistance of Moraxella catarrhalis in lower airways
Time frame: 12-15 months from study initiation
Results and safety
The study was stopped early (reason given: • Long delay due to challenges with sample analysis at local labs; • Low recruitment of case and control subjects; • Constant staff turn-over in the sites.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2014.
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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
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infections, Respiratory Tract, run by GlaxoSmithKline at 3 sites in United Kingdom.
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 14 inclusion and 4 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: stopped early, as of the sponsor's last update on 8 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United Kingdom. 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?
The study was stopped early (reason given: • Long delay due to challenges with sample analysis at local labs; • Low recruitment of case and control subjects; • Constant staff turn-over in the sites.). Results are not available in the source record.
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?
Occurrence of Haemophilus influenzae, in the absence of co-infection with other bacteria, in the lower airways of cases and controls (time frame: 12-15 months from study initiation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Sep 2014.