A Study of Streptococcus Pneumonia Colonisation and Invasive Disease in Cambodian Children

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03331952
• Date of registration: 01/11/2017
• Prospective Registration: No
• Primary sponsor: University of Oxford
• Public title: A Study of Streptococcus Pneumonia Colonisation and Invasive Disease in Cambodian Children PCV
• Scientific title: Monitoring Pneumococcal Conjugate Vaccine Introduction in Cambodia: A Study of Streptococcus Pneumoniae Colonisation, Pneumonia and Invasive Disease in Cambodian Children
• Date of first enrolment: August 3, 2015
• Target sample size: 4111
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03331952
• Study type: Observational

Countries of recruitment

Cambodia

Key inclusion & exclusion criteria

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.



Age minimum: N/A
Age maximum: 59 Months
Gender: All

Health Condition(s) or Problem(s) studied

Streptococcal Pneumonia

Intervention(s)

Other: Cross-sectional surveys

Other: Prospective study

Primary Outcome(s)

Invasive pneumococcal disease hospitalisation rates [Time Frame: 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]

Secondary Outcome(s)

Genotype in relation to national introduction of PCV13 [Time Frame: 3 years]

Pneumococcal colonisation prevalence [Time Frame: 3 years]

Antimicrobial susceptibility profiles in relation to national introduction of PCV13 [Time Frame: 3 years]

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]

Serotype in relation to national introduction of PCV13 [Time Frame: 3 years]

Compare pneumococcal serotype colonisation in pneumonia cases with children attending the hospital out-patients for minor illnesses [Time Frame: 3 years]

Secondary ID(s)

COMRU1501

Source(s) of Monetary Support

Please refer to primary and secondary sponsors