CoinfectionNCT02325102
Effects of Viral and Bacterial Co-infections in Otherwise Healthy Children Hospitalized in Pediatric Department
An observational study of Coinfection, run by Hillel Yaffe Medical Center.
Trial summary
Co-occurence of multiple pathogens in children is a known phenomenon, however the potential effect on the probability to develop a disease and on its severity, as well as the relationships between them, has not been studied adequately. Read more about this study
- Who is it for?
- Ages Up to 17 years
- Conditions the study is for
- Coinfection
- How many people
- 400 participants
- Where
- No sites listed yet
- Study dates
- Jun 2014to Dec 2014
- 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 Up to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: otherwise healthy children admitted in pediatric department
Who may be able to join
- Currently or recently febrile, otherwise healthy children aged 0 to 17 years admitted at several medical centers (Hillel Yaffe, Bnai Zion) in Israel, who were found to have viral, bacterial or both infections.
Who cannot join
- Afebrile for more than 72 hours
- Chronic illness
- Immune compromised (due to immunosuppressive drugs, neoplastic disease, etc.)
- History of prematurity or IUGR
- Not fully vaccinated for age according to national routine vaccination program
- Infection not being the primary diagnosis
Show all 10Show fewer
- Under antibiotic therapy:
- Currently receiving
- Recently received (less than 48 hours)
- No infection was documented during research period
About this study
Official title: Potential Clinical and Biological Effects of Viral and Bacterial Co-infections in Otherwise Healthy Children in Pediatric Department
Co-occurence of multiple pathogens in children is a known phenomenon, however the potential effect on the probability to develop a disease and on its severity, as well as the relationships between them, has not been studied adequately.
In this study, children admitted to the pediatric department with a clinical presentation of an infectious disease were tested for the presence of multiple pathogens. Data about their clinical status and about the accessory examinations performed during hospitalization were collected and analyzed.
Read the detailed description
Introduction The relationship between viral and bacterial infections in the respiratory tract in children has long been learnt and documented in the medical literature. A large scale American study which was held during the "swine flu" (influenza A H1N1) pandemic in 2009-2010 documented pneumonia (or other pulmonary infection) of bacterial source in one third of the patients admitted to intensive care units (PICU - Pediatric Intensive Care Unit) [1]. Similar data and even higher incidence rates also exist for bronchiolitis caused by RSV (respiratory syncytial virus) [2]. These and similar studies raise questions about the real need for antibiotic treatment and whether it is being judiciously prescribed (as it turned out, for example, that there are places in the world where 30-90% of the viral bronchiolitis cases are treated with antibiotics [3]), which puts the patient at risk for side effects and potentially increases bacterial resistance. Moreover, one cannot ignore the fact that otherwise healthy children and children with comorbidity (such as chronic carrier state or relevant background disease) are not always being addressed separately in these studies. Despite all this, there is consensus that children with respiratory viral disease, mainly one that requires hospitalization in PICU, will benefit from empirical antibiotic treatment [4, 5]. On the other hand, when it comes to the potential impact of antiviral treatment on the course of a pulmonary bacterial disease during infection with influenza virus, the results are not encouraging, but the seasonal vaccination plays a key role in reducing the above morbidity [6]. As to whether the presence of a viral infection at the same time affects the severity of pulmonary bacterial infection (i.e. The disease is more serious than that of a viral origin only), there is evidence demonstrating an increase in mortality, duration of mechanical ventilation and duration of hospitalization in mixed bacterial and viral disease [7]. Several studies found and isolated some viruses of different types in the same respiratory ailment, but unanimity as to whether there is correlation between the number of viruses and the severity of the disease is missing [8, 9].
In addition to the multiplicity of sources dealing with the link between viral and bacterial respiratory infections, especially influenza and RSV, there is recent evidence in the literature of a viral-bacterial etiology in acute otitis media [10, 11], but so far a limited number of works has been made about the same relationship of other viruses or in other systems.
The goals of this article:
- To determine whether the data available in the context of mixed infections in respiratory diseases (see above) are also valid for diseases in other body systems.
- To discover whether the relationship between viral and bacterial infection is as strong as in the respiratory system
- to study the impact of the co-infection on morbidity (severity, length of stay, complications)
- to link between specific infection and its common mixed pathogens
- to specify age sections, gender, demographic characteristics, clinical condition, at which co-infections (and relevant consequences) predominate
Methods The study group comprised currently or recently febrile, otherwise healthy children aged 0 to 17 years admitted at several medical centers (Hillel Yaffe, Bnai Zion) in Israel, who were found to have viral, bacterial or both infections. Exclusion criteria are listed below (Table 1).
When a child meeting the above criteria was admitted, parent (or child's legal custodian) were given verbal and written explanation by a clinical investigator, signed an informed consent and approved him to collect blood samples and nasal or rectal swab. In accordance to the clinical presentation, additional tests were performed and included blood, urine and stool cultures and some viral and bacterial serologies.
For each patient, individual history was taken; presenting symptoms, physical examinations and lab results were documented; and additional data such as antibiotic therapy, length of stay and complications were collected during hospitalization by authorized medical staff using standard techniques and methods.
Specimen sampling:
- Nasal swab
- Blood sampling with CBC and chemistry tubes
- Rectal swab (only in case of diarrhea)
Laboratory procedures:
Specimens were immediately placed in a refrigerator at 4°C, transferred to MeMed laboratory no longer than 5 hours following sampling.
In the laboratory, blood tests included CBC, bacterial and viral PCR incl. ELISA.
Although clinical signs were usually documented in a great detail, this method is problematic and prone bias for the purpose of defining infection, owing to the investigator's individual interpretation. Thus, in this study only microbiological definitions were used. Viral infection was defined as PCR positive for viral genome or as the presence of IgM antibody against viral specific antigen.
Bacterial infection required PCR positive for bacterial genome sequence, or colony counts 105 cfu/ml of diagnostic sample for each single species obtained, or the presence of IgM antibody against bacterial specific.
Data analysis:
All of the above information was transferred to and arranged in a designated database developed and maintained by the sub-investigators.
In the database, the investigators applied the exclusion criteria, found all patients with viral and bacterial co-infections and analyzed the investigated variants.
Table 1: Exclusion Criteria Afebrile for more than 72 hours
Chronic illness Immune compromised (due to immunosuppressive drugs, neoplastic disease, etc.) History of prematurity or IUGR Not fully vaccinated for age according to national routine vaccination program
Infection not being the primary diagnosis
Under antibiotic therapy:
Currently receiving Recently received (less than 48 hours) No infection was documented during research period
- Conditions
- Coinfection
- Being tested
- No intervention
- Medical subject headings
- Coinfection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
As this is an observational study, no intervention was conducted.
What is being measured
The primary outcome is the main question the study is designed to answer.
number of patients with co-infections
Patients in whom 2 or more pathogens were found in culture, serology or other tests.
Measured: 2 years
Secondary outcomes (1)
Types and species of pathogens
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2014 (estimated)
- Study startJun 2014
- Primary completionSep 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for CoinfectionStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hillel Yaffe Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Nitai A Levy, MD, Principal investigator, Physician
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02325102
- Sponsor's protocol ID
- HMC102-13
- Status last verified
- Dec 2014
- First submitted
- 2 Dec 2014
- Last updated
- 24 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Randolph AG, Vaughn F, Sullivan R, Rubinson L, Thompson BT, Yoon G, Smoot E, Rice TW, Loftis LL, Helfaer M, Doctor A, Paden M, Flori H, Babbitt C, Graciano AL, Gedeit R, Sanders RC, Giuliano JS, Zimmerman J, Uyeki TM; Pediatric Acute Lung Injury and Sepsis Investigator's Network and the National Heart, Lung, and Blood Institute ARDS Clinical Trials Network. Critically ill children during the 2009-2010 influenza pandemic in the United States. Pediatrics. 2011 Dec;128(6):e1450-8. doi: 10.1542/peds.2011-0774. Epub 2011 Nov 7.
PubMed 22065262Thorburn K, Harigopal S, Reddy V, Taylor N, van Saene HK. High incidence of pulmonary bacterial co-infection in children with severe respiratory syncytial virus (RSV) bronchiolitis. Thorax. 2006 Jul;61(7):611-5. doi: 10.1136/thx.2005.048397. Epub 2006 Mar 14.
PubMed 16537670Spurling GK, Fonseka K, Doust J, Del Mar C. Antibiotics for bronchiolitis in children. Cochrane Database Syst Rev. 2007 Jan 24;(1):CD005189. doi: 10.1002/14651858.CD005189.pub2.
PubMed 17253545Levin D, Tribuzio M, Green-Wrzesinki T, Ames B, Radwan S, Jarvis JD, Vaccaro T, Modlin JF. Empiric antibiotics are justified for infants with respiratory syncytial virus lower respiratory tract infection presenting with respiratory failure: a prospective study and evidence review. Pediatr Crit Care Med. 2010 May;11(3):390-5. doi: 10.1097/PCC.0b013e3181b809c5.
PubMed 19838143American Academy of Pediatrics Subcommittee on Diagnosis and Management of Bronchiolitis. Diagnosis and management of bronchiolitis. Pediatrics. 2006 Oct;118(4):1774-93. doi: 10.1542/peds.2006-2223.
PubMed 17015575
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Potential Clinical and Biological Effects of Viral and Bacterial Co-infections in Otherwise Healthy Children in Pediatric Department
- ClinicalTrials.gov ID
- NCT02325102
- Acronym / sponsor ID
- HMC102-13
- Conditions
- Coinfection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Hillel Yaffe Medical CenterOther government
- Study start
- Jun 2014
- Primary completion
- Sep 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 24 Dec 2014 (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.
Co-occurence of multiple pathogens in children is a known phenomenon, however the potential effect on the probability to develop a disease and on its severity, as well as the relationships between them, has not been studied adequately.
In this study, children admitted to the pediatric department with a clinical presentation of an infectious disease were tested for the presence of multiple pathogens. Data about their clinical status and about the accessory examinations performed during hospitalization were collected and analyzed.
Detailed description
Introduction The relationship between viral and bacterial infections in the respiratory tract in children has long been learnt and documented in the medical literature. A large scale American study which was held during the "swine flu" (influenza A H1N1) pandemic in 2009-2010 documented pneumonia (or other pulmonary infection) of bacterial source in one third of the patients admitted to intensive care units (PICU - Pediatric Intensive Care Unit) [1]. Similar data and even higher incidence rates also exist for bronchiolitis caused by RSV (respiratory syncytial virus) [2]. These and similar studies raise questions about the real need for antibiotic treatment and whether it is being judiciously prescribed (as it turned out, for example, that there are places in the world where 30-90% of the viral bronchiolitis cases are treated with antibiotics [3]), which puts the patient at risk for side effects and potentially increases bacterial resistance. Moreover, one cannot ignore the fact that otherwise healthy children and children with comorbidity (such as chronic carrier state or relevant background disease) are not always being addressed separately in these studies. Despite all this, there is consensus that children with respiratory viral disease, mainly one that requires hospitalization in PICU, will benefit from empirical antibiotic treatment [4, 5]. On the other hand, when it comes to the potential impact of antiviral treatment on the course of a pulmonary bacterial disease during infection with influenza virus, the results are not encouraging, but the seasonal vaccination plays a key role in reducing the above morbidity [6]. As to whether the presence of a viral infection at the same time affects the severity of pulmonary bacterial infection (i.e. The disease is more serious than that of a viral origin only), there is evidence demonstrating an increase in mortality, duration of mechanical ventilation and duration of hospitalization in mixed bacterial and viral disease [7]. Several studies found and isolated some viruses of different types in the same respiratory ailment, but unanimity as to whether there is correlation between the number of viruses and the severity of the disease is missing [8, 9].
In addition to the multiplicity of sources dealing with the link between viral and bacterial respiratory infections, especially influenza and RSV, there is recent evidence in the literature of a viral-bacterial etiology in acute otitis media [10, 11], but so far a limited number of works has been made about the same relationship of other viruses or in other systems.
The goals of this article:
- To determine whether the data available in the context of mixed infections in respiratory diseases (see above) are also valid for diseases in other body systems.
- To discover whether the relationship between viral and bacterial infection is as strong as in the respiratory system
- to study the impact of the co-infection on morbidity (severity, length of stay, complications)
- to link between specific infection and its common mixed pathogens
- to specify age sections, gender, demographic characteristics, clinical condition, at which co-infections (and relevant consequences) predominate
Methods The study group comprised currently or recently febrile, otherwise healthy children aged 0 to 17 years admitted at several medical centers (Hillel Yaffe, Bnai Zion) in Israel, who were found to have viral, bacterial or both infections. Exclusion criteria are listed below (Table 1).
When a child meeting the above criteria was admitted, parent (or child's legal custodian) were given verbal and written explanation by a clinical investigator, signed an informed consent and approved him to collect blood samples and nasal or rectal swab. In accordance to the clinical presentation, additional tests were performed and included blood, urine and stool cultures and some viral and bacterial serologies.
For each patient, individual history was taken; presenting symptoms, physical examinations and lab results were documented; and additional data such as antibiotic therapy, length of stay and complications were collected during hospitalization by authorized medical staff using standard techniques and methods.
Specimen sampling:
- Nasal swab
- Blood sampling with CBC and chemistry tubes
- Rectal swab (only in case of diarrhea)
Laboratory procedures:
Specimens were immediately placed in a refrigerator at 4°C, transferred to MeMed laboratory no longer than 5 hours following sampling.
In the laboratory, blood tests included CBC, bacterial and viral PCR incl. ELISA.
Although clinical signs were usually documented in a great detail, this method is problematic and prone bias for the purpose of defining infection, owing to the investigator's individual interpretation. Thus, in this study only microbiological definitions were used. Viral infection was defined as PCR positive for viral genome or as the presence of IgM antibody against viral specific antigen.
Bacterial infection required PCR positive for bacterial genome sequence, or colony counts 105 cfu/ml of diagnostic sample for each single species obtained, or the presence of IgM antibody against bacterial specific.
Data analysis:
All of the above information was transferred to and arranged in a designated database developed and maintained by the sub-investigators.
In the database, the investigators applied the exclusion criteria, found all patients with viral and bacterial co-infections and analyzed the investigated variants.
Table 1: Exclusion Criteria Afebrile for more than 72 hours
Chronic illness Immune compromised (due to immunosuppressive drugs, neoplastic disease, etc.) History of prematurity or IUGR Not fully vaccinated for age according to national routine vaccination program
Infection not being the primary diagnosis
Under antibiotic therapy:
Currently receiving Recently received (less than 48 hours) No infection was documented during research period
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- Up to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- otherwise healthy children admitted in pediatric department
Key inclusion criteria (1 listed)
- Currently or recently febrile, otherwise healthy children aged 0 to 17 years admitted at several medical centers (Hillel Yaffe, Bnai Zion) in Israel, who were found to have viral, bacterial or both infections.
Key exclusion criteria (10 listed)
- Afebrile for more than 72 hours
- Chronic illness
- Immune compromised (due to immunosuppressive drugs, neoplastic disease, etc.)
- History of prematurity or IUGR
- Not fully vaccinated for age according to national routine vaccination program
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 |
|---|---|---|
| No interventionAs this is an observational study, no intervention was conducted. | Other | – |
Primary outcome
number of patients with co-infections
Time frame: 2 years
Patients in whom 2 or more pathogens were found in culture, serology or other tests.
1 secondary outcome
Types and species of pathogens
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2014.
- Background: PubMed 22065262Randolph AG, Vaughn F, Sullivan R, Rubinson L, Thompson BT, Yoon G, Smoot E, Rice TW, Loftis LL, Helfaer M, Doctor A, Paden M, Flori H, Babbitt C, Graciano AL, Gedeit R, Sanders RC, Giuliano JS, Zimmerman J, Uyeki TM; Pediatric Acute Lung Injury and Sepsis Investigator's Network and the National Heart, Lung, and Blood Institute ARDS Clinical Trials Network. Critically ill children during the 2009-2010 influenza pandemic in the United States. Pediatrics. 2011 Dec;128(6):e1450-8. doi: 10.1542/peds.2011-0774. Epub 2011 Nov 7.
- Background: PubMed 16537670Thorburn K, Harigopal S, Reddy V, Taylor N, van Saene HK. High incidence of pulmonary bacterial co-infection in children with severe respiratory syncytial virus (RSV) bronchiolitis. Thorax. 2006 Jul;61(7):611-5. doi: 10.1136/thx.2005.048397. Epub 2006 Mar 14.
- Background: PubMed 17253545Spurling GK, Fonseka K, Doust J, Del Mar C. Antibiotics for bronchiolitis in children. Cochrane Database Syst Rev. 2007 Jan 24;(1):CD005189. doi: 10.1002/14651858.CD005189.pub2.
- Background: PubMed 19838143Levin D, Tribuzio M, Green-Wrzesinki T, Ames B, Radwan S, Jarvis JD, Vaccaro T, Modlin JF. Empiric antibiotics are justified for infants with respiratory syncytial virus lower respiratory tract infection presenting with respiratory failure: a prospective study and evidence review. Pediatr Crit Care Med. 2010 May;11(3):390-5. doi: 10.1097/PCC.0b013e3181b809c5.
- Background: PubMed 17015575American Academy of Pediatrics Subcommittee on Diagnosis and Management of Bronchiolitis. Diagnosis and management of bronchiolitis. Pediatrics. 2006 Oct;118(4):1774-93. doi: 10.1542/peds.2006-2223.
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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.
Nitai A Levy, MD principal investigator
Physician
Questions about this trial
What is this clinical trial studying?
An observational study of Coinfection, run by Hillel Yaffe Medical Center.
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 1 inclusion and 10 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 24 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 patients with co-infections (time frame: 2 years). 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 NCT02325102, which also lists 5 linked publications.
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 24 Dec 2014.