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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2012 by Agence de Médecine Préventive, France
Sponsor:
Collaborators:
Savanes Sanitary Region Togo
Ministry of Health, Togo
National Reference Laboratory for Epidemic Disease Togo
Centre Muraz
Fondation Mérieux
Pfizer
Information provided by (Responsible Party):
Agence de Médecine Préventive, France
ClinicalTrials.gov Identifier:
NCT01747369
First received: July 4, 2011
Last updated: December 10, 2012
Last verified: December 2012
  Purpose

The aim of this study is to estimate the burden of disease due to pneumococci, other bacteria and viruses in the African meningitis belt. In a defined population of a sanitary district in northern Togo, during the period 2010 to 2013, the investigators enroll patients of all age with suspected pneumonia requiring hospitalisation 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.


Condition
Pneumonia, Bacterial
Pneumonia, Viral
Meningitis, Bacterial

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective

Resource links provided by NLM:


Further study details as provided by Agence de Médecine Préventive, France:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Whole blood, cerebro-spinal fluid, nasal aspirate


Estimated Enrollment: 2000
Study Start Date: April 2010
Estimated Study Completion Date: April 2013
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01747369

Contacts
Contact: Makawa-Sy Makawa, MD +228-921 29 31 makmaksy@yahoo.fr
Contact: Haoua Tall, PharmD MPH +226-50300406 htall@aamp.org

Locations
Togo
Centre médico-social (CMS) Recruiting
Cinkassé, Savanes region, Togo
Centre Hospitalier Régional (CHR) Savanes Recruiting
Dapaong, Savanes region, Togo
Hôpital d'enfants Yendubé Recruiting
Dapaong, Savanes region, Togo
Clinique Win' Pang Recruiting
Dapaong, Savanes region, Togo
Polyclinique Recruiting
Dapaong, Savanes region, Togo
Sponsors and Collaborators
Agence de Médecine Préventive, France
Savanes Sanitary Region Togo
Ministry of Health, Togo
National Reference Laboratory for Epidemic Disease Togo
Centre Muraz
Fondation Mérieux
Pfizer
Investigators
Principal Investigator: Jennifer C Moïsi, PhD Agence de Médecine Préventive
  More Information

No publications provided

Responsible Party: Agence de Médecine Préventive, France
ClinicalTrials.gov Identifier: NCT01747369     History of Changes
Other Study ID Numbers: PneumoTone
Study First Received: July 4, 2011
Last Updated: December 10, 2012
Health Authority: Togo: Ministry of Health

Keywords provided by Agence de Médecine Préventive, France:
surveillance study
prospective
observational
health center-based
pneumonia, bacterial
pneumonia, viral
meningitis, bacterial
Africa south of the Sahara

Additional relevant MeSH terms:
Pneumonia, Bacterial
Pneumonia
Pneumonia, Viral
Meningitis
Meningitis, Bacterial
Bacterial Infections
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Central Nervous System Infections
Central Nervous System Diseases
Nervous System Diseases
Virus Diseases
Central Nervous System Bacterial Infections

ClinicalTrials.gov processed this record on September 14, 2014