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

Pneumonia, Viral Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01747369
• Other study ID #: PneumoTone
• Status: Recruiting
• Phase: N/A
• First received: July 4, 2011
• Last updated: March 3, 2017
• Start date: April 2010
• Est. completion date: June 2017

Study information

• Verified date: March 2017
• Source: Agence de Médecine Préventive, France
• Contact: Makawa-Sy Makawa, MD
• Phone: +228-921 29 31
• Email: makmaksy[@]yahoo.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: June 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Meningitis
• Meningitis, Bacterial
• Pneumonia
• Pneumonia, Bacterial
• Pneumonia, Viral

Locations

Country	Name	City	State
Togo	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

Sponsors (7)

Lead Sponsor	Collaborator
Agence de Médecine Préventive, France	Centre Muraz, Fondation Mérieux, France, Institut National d'Hygiene, Togo, Ministere de la Sante et de la Promotion Sociale, Togo, Pfizer, Region Sanitaire des Savanes, Togo

Country where clinical trial is conducted

Togo, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)