Surveillance of Hospitalised Pneumonia and Bacterial Meningitis in Tône District, Togo, 2010-2013
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 2,000
- Locations
- 5
- Primary Endpoint
- Incidence of pneumococcal meningitis, confirmed by culture or PCR on cerebro-spinal fluid
Study Overview
Brief Summary
The aim of this study is to estimate the burden of disease due to pneumococci, other bacteria and viruses in the African meningitis belt prior to pneumococcal conjugate vaccine introduction and to estimate the population impact of the vaccine after its implementation in 2014. In a defined population of a sanitary district in northern Togo, during the period 2010 to 2017, investigators enroll patients of all ages with suspected pneumonia requiring hospitalization or suspected bacterial meningitis. Patients are evaluated by bacteriology and molecular biology techniques on blood, cerebro-spinal fluid, nasal aspirates and by chest X-ray.
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Prospective
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •resident of Tône sanitary district - requiring hospitalisation for at least one night for clinical pneumonia syndrome
- •hospitalised in a study site during the study period
Exclusion Criteria
- •absence of informed consent by patient or legal tutor
- •Meningitis surveillance:
- •Inclusion Criteria:
- •resident of Tône sanitary district
- •presenting clinical signs of acute bacterial meningitis
- •hospitalised in a study site during the study period
- •Exclusion Criteria:
- •absence of informed consent by patient or legal tutor
Outcomes
Primary Outcomes
Incidence of pneumococcal meningitis, confirmed by culture or PCR on cerebro-spinal fluid
Time Frame: Subjects will be enrolled on admission to hospital and followed for the duration of hospitalization (median duration 6 days)
Incidence of pneumococcal pneumonia requiring hospitalisation, confirmed by blood culture or PCR analysis of blood
Time Frame: Subjects will be enrolled on admission to hospital and followed for the duration of hospitalization (median duration 6 days)
Secondary Outcomes
- Incidence of suspected pneumonia requiring hospitalisation with elevated C-reactive protein serum concentration (<40mg/l)(Subjects will be enrolled on admission to hospital and followed for the duration of hospitalization (median duration 6 days))
- Incidence of radiologically confirmed pneumonia requiring hospitalisation(Subjects will be enrolled on admission to hospital and followed for the duration of hospitalization (median duration 6 days))
- Incidence of suspected pneumonia requiring hospitalisation with reduced oxygen saturation (<90%)(Subjects will be enrolled on admission to hospital and followed for the duration of hospitalization (median duration 6 days))
- Incidence of acute meningitis of other bacterial etiology(Subjects will be enrolled on admission to hospital and followed for the duration of hospitalization (median duration 6 days))
- Incidence of pneumonia of other bacterial or viral etiology requiring hospitalisation(Subjects will be enrolled on admission to hospital and followed for the duration of hospitalization (median duration 6 days))