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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

Official Title:

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 Summary:
Sponsor: Agence de Médecine Préventive, France

Current Primary Outcome:

  • 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) ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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) ]
  • 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) ]


Original Secondary Outcome: Same as current

Information By: Agence de Médecine Préventive, France

Dates:
Date Received: July 4, 2011
Date Started: April 2010
Date Completion: June 2017
Last Updated: March 3, 2017
Last Verified: March 2017