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

Sponsor

Agence de Médecine Préventive, France (Other)

Overall Status

Unknown status

CT.gov ID

NCT01747369

Collaborator

Region Sanitaire des Savanes, Togo (Other), Ministere de la Sante et de la Promotion Sociale, Togo (Other), Institut National d'Hygiene, Togo (Other), Centre Muraz (Other), Fondation Mérieux, France (Other), Pfizer (Industry)

2,000

Enrollment

Locations

Anticipated Duration (Months)

400

Patients Per Site

4.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pneumonia, Bacterial Pneumonia, Viral Meningitis, Bacterial

Study Design

Study Type:

Observational

Anticipated Enrollment :

2000 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Actual Study Start Date :

Apr 1, 2010

Anticipated Primary Completion Date :

Jun 1, 2017

Anticipated Study Completion Date :

Jun 1, 2017

Outcome Measures

Primary Outcome Measures

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)]
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)]

Secondary Outcome Measures

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 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 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 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)]
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)]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Pneumonia surveillance:

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

Contacts and Locations

Locations

	Site	City	State	Country
1	Centre médico-social (CMS)	Cinkassé	Savanes region	Togo
2	Centre Hospitalier Régional (CHR) Savanes	Dapaong	Savanes region	Togo
3	Clinique Win' Pang	Dapaong	Savanes region	Togo
4	Hôpital d'enfants Yendubé	Dapaong	Savanes region	Togo
5	Polyclinique	Dapaong	Savanes region	Togo