- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03331952
A Study of Streptococcus Pneumonia Colonisation and Invasive Disease in Cambodian Children (PCV)
Monitoring Pneumococcal Conjugate Vaccine Introduction in Cambodia: A Study of Streptococcus Pneumoniae Colonisation, Pneumonia and Invasive Disease in Cambodian Children
Streptococcus pneumoniae (the pneumococcus) remains a leading cause of childhood mortality and morbidity. Between 2007 and 2012, Angkor Hospital for Children (AHC), Siem Reap, Cambodia documented that S. pneumoniae was responsible for around 10% of bloodstream infections in hospitalised children, with a case fatality rate of 15.6%.
The use of pneumococcal conjugate vaccines (PCV), covering between 7 and 13 of the >90 pneumococcal serotypes, has resulted in significant declines in invasive pneumococcal disease (IPD) incidence in countries where they are included in routine childhood immunisation schedules. Paediatric radiologic pneumonia incidence is also reduced by PCV, but the impact on clinical pneumonia is minimal. The vaccines have had an effect on reducing the burden of drug resistant IPD, although this may not be sustained. Given the large number of serotypes not included in the current PCV formulations, it is not surprising that initial declines in overall IPD incidence have been eroded by, for the time being, small increases in IPD due to non-vaccine serotypes. To date most data on this serotype replacement disease has come from high-income countries. It less clear how much serotype replacement will occur in low and middle income countries, where pre-PCV disease incidence is generally higher and other factors, such as unregulated antimicrobial consumption, may play a role in encouraging non-vaccine serotype infections.
Nasopharyngeal colonisation by S. pneumoniae is common in childhood and is an essential prerequisite for invasive disease. Surveillance of pneumococcal colonisation can provide important data regarding serotype replacement and disease-associated serotypes, and may also allow prediction of likely IPD incidence changes post-vaccine introduction. A recent study of pneumococcal colonisation in children attending the AHC out-patients has documented an overall colonisation prevalence of approximately 65%.
In January 2015, Cambodia will introduce the 13-valent PCV (PCV13; serotypes covered 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19F, 19A, 23F). The vaccine will be rolled out nationally with a 3+0 dosing schedule (6, 10 and 14 weeks) and no catch up campaign. There is no robust national surveillance system in place to monitor the effects of PCV13 introduction.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Siem Reap, Cambodia
- Angkor Hospital for Children
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Group1: This is a prospective study to identify and characterise patients with culture proven invasive pneumococcal disease or probable bacterial meningitis over the first three years after PCV13 introduction in Cambodia in January 2015.
Group2: This is a prospective study to identify and characterise patients hospitalised with clinical and/or radiologic pneumonia over the first three years after PCV13 introduction in Cambodia in January 2015.
Group3: Three annual surveys, enrolling 450 children each year, will be done to identify and characterise pneumococcal nasopharyngeal colonisation in AHC out-patient department (OPD) attendees.
Description
Group1: PCV-D
Inclusion:
- Age: 0 - 59 months on the day of assessment / culture AND
- S.pneumoniae identified from a normally sterile site culture. OR
WHO Coordinated Invasive Bacterial Vaccine Preventable Diseases (IB-VPD) Surveillance Network Case Definition for probable bacterial meningitis. Clinically suspected meningitis and a CSF examination with at least one of:
- Turbid appearance.
- Leucocytosis (WBC count of >100 cells/mm3).
- Leucocytosis (10-100 cells/mm3) AND either an elevated protein (>100 mg/dL) or decreased glucose (<2.2 mmol/L).
Exclusion:
- Previous enrolment within the last 14 days.
- Parent / guardian or caretaker refused consent.
Group2: PCV-P
Inclusion:
- Age: 0 - 59 months on the day of admission AND
- Admission to the IPD, ER/ICU, or NICU/SCBU. AND
Meets the WHO Coordinated Invasive Bacterial Vaccine Preventable Diseases (IB-VBD) Surveillance Network pneumonia / severe pneumonia case definition:
- Cough and/or difficulty breathing. AND
- Tachypnoea OR
- Inability to breast feed or drink.
- Vomiting everything.
- Convulsions.
- Prostration/lethargy.
- Chest indrawing.
- Stridor when calm.
Exclusion:
- Previous enrolment within the last 14 days.
- Parent / guardian or caretaker refused consent.
Group3: PCV-C
Inclusion:
• Age: 0 - 59 months on the day of recruitment
Exclusion:
- Parent / guardian or caretaker reports symptoms of potential acute lower respiratory tract illness.
- Triage nurse selects child for doctor review / hospital admission.
- Previous enrolment in the current annual survey.
- Parent / guardian or caretaker refused consent.
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Invasive pneumococcal disease study (PCV-D)
Prospective study of children with invasive pneumococcal disease / probable bacterial meningitis (PCV-D) Clinical procedures At study enrolment:
Radiology procedures As part of routine clinical management at AHC, a digital chest radiograph (CXR) may be performed as part of a child's diagnostic work up. CXRs will be read and interpreted primarily by the AHC radiologists. All CXR will subsequently be re-read by two study clinicians and interpreted according to the WHO paediatric radiologic pneumonia criteria. Laboratory procedures • Residual routine clinical specimens further analysed as part of the study protocol:
|
To identify and characterise patients with culture proven invasive pneumococcal disease or probable bacterial meningitis over the first three years after PCV13 introduction in Cambodia in January 2015.
To identify and characterise patients hospitalised with clinical and/or radiologic pneumonia over the first three years after PCV13 introduction in Cambodia in January 2015
|
Pneumonia study (PCV-P)
Prospective study of children hospitalised with clinical and/or radiologic pneumonia (PCV-P) Clinical procedures As described for PCV-D. Radiology procedures As part of routine clinical management at AHC, a digital chest radiograph (CXR) is performed on all children with an admission diagnosis of pneumonia. CXRs will be handled as described for PCV-D. Laboratory procedures
|
To identify and characterise patients with culture proven invasive pneumococcal disease or probable bacterial meningitis over the first three years after PCV13 introduction in Cambodia in January 2015.
To identify and characterise patients hospitalised with clinical and/or radiologic pneumonia over the first three years after PCV13 introduction in Cambodia in January 2015
|
Pneumococcal colonisation study (PCV-C)
Cross-sectional pneumococcal colonisation surveys in children attending the AHC out-patient department (PCV-C) Three annual surveys, enrolling 450 children each year, will be done to identify and characterise pneumococcal nasopharyngeal colonisation in AHC out-patient department (OPD) attendees. Clinical procedures • Subjects will be recruited from the OPD waiting area after nurse triage. A questionnaire will be administered to the parent / guardian or caretaker to assess the child's immunisation status (by review of the handheld immunisation card where possible), household structure, environmental exposures, and recent antimicrobial use. Laboratory procedures • Study specific specimens: o Nasopharyngeal swab at enrolment. A nasopharyngeal swab will be collected from each participant and these will be processed as described for PCV-P. |
Three annual surveys, enrolling 450 children each year, will be done to identify and characterise pneumococcal nasopharyngeal colonisation in AHC out-patient department (OPD) attendees
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Invasive pneumococcal disease hospitalisation rates
Time Frame: 3 years
|
3 years
|
Characteristics of invasive S. pneumoniae isolates in children <5 years of age admitted to Angkor Hospital for Children, in relation to national introduction of PCV13 in Cambodia
Time Frame: 3 years
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3 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Changes in pneumonia (both clinical and radiologic) hospitalisation rates in children <5 years of age, in relation to national introduction of PCV13 in Cambodia
Time Frame: 3 years
|
3 years
|
Pneumococcal colonisation prevalence
Time Frame: 3 years
|
3 years
|
Antimicrobial susceptibility profiles in relation to national introduction of PCV13
Time Frame: 3 years
|
3 years
|
Serotype in relation to national introduction of PCV13
Time Frame: 3 years
|
3 years
|
Genotype in relation to national introduction of PCV13
Time Frame: 3 years
|
3 years
|
Compare pneumococcal serotype colonisation in pneumonia cases with children attending the hospital out-patients for minor illnesses
Time Frame: 3 years
|
3 years
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- COMRU1501
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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