Surveillance of Hospitalised Pneumonia and Bacterial Meningitis in Tône District, Togo, 2010-2013

• Conditions: Meningitis, Bacterial; Pneumonia, Bacterial; Pneumonia, Viral

• Registration Number: NCT01747369
• Lead Sponsor: Agence de Médecine Préventive, France

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-04
• Study First Submitted: 2011-07-04
• Study First Submitted QC: 2012-12-10
• Study First Posted: 2012-12-11
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-03
• Last Update Posted: 2017-03-06
• Primary Completion: 2017-06
• Study Completion: 2017-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 2000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of pneumococcal meningitis, confirmed by culture or PCR on cerebro-spinal fluid	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	Subjects will be enrolled on admission to hospital and followed for the duration of hospitalization (median duration 6 days)

Secondary Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (5)

Centre médico-social (CMS); 🇹🇬 Cinkassé, Savanes region, Togo

Centre Hospitalier Régional (CHR) Savanes; 🇹🇬 Dapaong, Savanes region, Togo

Clinique Win' Pang; 🇹🇬 Dapaong, Savanes region, Togo

Hôpital d'enfants Yendubé; 🇹🇬 Dapaong, Savanes region, Togo

Polyclinique; 🇹🇬 Dapaong, Savanes region, Togo