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Clinical Trials/NCT01747369
NCT01747369
Unknown
Not Applicable

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

Agence de Médecine Préventive, France5 sites in 1 country2,000 target enrollmentApril 2010

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pneumonia, Bacterial
Sponsor
Agence de Médecine Préventive, France
Enrollment
2000
Locations
5
Primary Endpoint
Incidence of pneumococcal meningitis, confirmed by culture or PCR on cerebro-spinal fluid
Last Updated
9 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 2010
End Date
June 2017
Last Updated
9 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Agence de Médecine Préventive, France
Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

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)

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)

Secondary Outcomes

  • 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))

Study Sites (5)

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