Status:
COMPLETED
A Study of Streptococcus Pneumonia Colonisation and Invasive Disease in Cambodian Children
Lead Sponsor:
University of Oxford
Conditions:
Streptococcal Pneumonia
Eligibility:
All Genders
Up to 59 years
Brief Summary
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...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
August 3 2015
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 19 2018
Estimated Enrollment :
4111 Patients enrolled
Trial Details
Trial ID
NCT03331952
Start Date
August 3 2015
End Date
October 19 2018
Last Update
October 9 2020
Active Locations (1)
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1
Angkor Hospital for Children
Siem Reap, Cambodia