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

March 3, 2017 updated by: Agence de Médecine Préventive, France
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.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

2000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Togo
    • Savanes region
      • Cinkassé, Savanes region, Togo
        • Recruiting
        • Centre médico-social (CMS)
      • Dapaong, Savanes region, Togo
        • Recruiting
        • Centre Hospitalier Régional (CHR) Savanes
      • Dapaong, Savanes region, Togo
        • Recruiting
        • Clinique Win' Pang
      • Dapaong, Savanes region, Togo
        • Recruiting
        • Hôpital d'enfants Yendubé
      • Dapaong, Savanes region, Togo
        • Recruiting
        • Polyclinique

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Pneumonia surveillance:

-residents of Tône sanitary district requiring hospitaliation for suspected pneumonia and presenting at one of the hospitals of Dapaong town (district capital)

Meningitis surveillance:

- residents fo Tône sanitary district presenting with suspected meningitis at one of the hospitals of Dapaong town (district capital) or Sinkasse health center

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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)
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)
Subjects will be enrolled on admission to hospital and followed for the duration of hospitalization (median duration 6 days)

Secondary Outcome Measures

Outcome Measure
Time Frame
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)
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)
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)
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)
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)
Subjects will be enrolled on admission to hospital and followed for the duration of hospitalization (median duration 6 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Agence de Médecine Préventive, France

Collaborators

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

Investigators

  • Principal Investigator: Jennifer C Moïsi, PhD, Agence de Médecine Préventive

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2010

Primary Completion (Anticipated)

June 1, 2017

Study Completion (Anticipated)

June 1, 2017

Study Registration Dates

First Submitted

July 4, 2011

First Submitted That Met QC Criteria

December 10, 2012

First Posted (Estimate)

December 11, 2012

Study Record Updates

Last Update Posted (Actual)

March 6, 2017

Last Update Submitted That Met QC Criteria

March 3, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PneumoTone

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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