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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 16 December 2017
Main ID:  NCT01747369
Date of registration: 04/07/2011
Prospective Registration: No
Primary sponsor: Agence de Médecine Préventive, France
Public title: Surveillance of Hospitalised Pneumonia and Bacterial Meningitis in Tône District, Togo, 2010-2013
Scientific title:
Date of first enrolment: April 2010
Target sample size: 2000
Recruitment status: Recruiting
URL:  https://clinicaltrials.gov/show/NCT01747369
Study type:  Observational
Study design:   
Phase:  N/A
Countries of recruitment
Togo
Contacts
Name:     Makawa-Sy Makawa, MD
Address: 
Telephone: +228-921 29 31
Email: makmaksy@yahoo.fr
Affiliation: 
Name:     Jennifer C Moïsi, PhD
Address: 
Telephone:
Email:
Affiliation:  Agence de Médecine Préventive
Key inclusion & exclusion criteria

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



Age minimum: N/A
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
Pneumonia, Bacterial
Pneumonia, Viral
Meningitis, Bacterial
Intervention(s)
Primary Outcome(s)
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)]
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)]
Secondary Outcome(s)
Incidence of acute meningitis of other bacterial etiology [Time Frame: 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 [Time Frame: 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) [Time Frame: 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%) [Time Frame: 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 [Time Frame: Subjects will be enrolled on admission to hospital and followed for the duration of hospitalization (median duration 6 days)]
Secondary ID(s)
PneumoTone
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Centre Muraz
Pfizer
Fondation Mérieux, France
Institut National d'Hygiene, Togo
Ministere de la Sante et de la Promotion Sociale, Togo
Region Sanitaire des Savanes, Togo
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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