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

NCT01747369 | Unknown

• 1 other identifier: PneumoTone
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 5

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.

Conditions

Pneumonia, Bacterial; Pneumonia, Viral; Meningitis, Bacterial

Keywords

surveillance study; prospective; observational; health center-based; pneumonia, bacterial; pneumonia, viral; meningitis, bacterial; Africa south of the Sahara

Outcome Measures

Primary Outcomes (2)

• Incidence of pneumococcal pneumonia requiring hospitalisation, confirmed by blood culture or PCR analysis of blood

  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

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

Secondary Outcomes (5)

• 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 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 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 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)

• 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)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• absence of informed consent by patient or legal tutor
• Meningitis surveillance:
• resident of Tône sanitary district
• presenting clinical signs of acute bacterial meningitis
• hospitalised in a study site during the study period
• absence of informed consent by patient or legal tutor

Sponsors & Collaborators

• Agence de Médecine Préventive, France: lead
• Region Sanitaire des Savanes, Togo: collaborator
• Ministere de la Sante et de la Promotion Sociale, Togo: collaborator
• Institut National d'Hygiene, Togo: collaborator
• Centre Muraz: collaborator
• Fondation Mérieux, France: collaborator
• Pfizer: collaborator

Study Sites (5)

Centre Hospitalier Régional (CHR) Savanes

Dapaong, Savanes, Togo

RECRUITING

Clinique Win' Pang

Dapaong, Savanes, Togo

RECRUITING

Hôpital d'enfants Yendubé

Dapaong, Savanes, Togo

RECRUITING

Polyclinique

Dapaong, Savanes, Togo

RECRUITING

Centre médico-social (CMS)

Sinkassé, Savanes, Togo

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood, cerebro-spinal fluid, nasal aspirate

MeSH Terms

Conditions

Pneumonia, Bacterial; Pneumonia, Viral; Meningitis, Bacterial

Condition Hierarchy (Ancestors)

Bacterial Infections; Bacterial Infections and Mycoses; Infections; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Virus Diseases; Central Nervous System Bacterial Infections; Central Nervous System Infections; Central Nervous System Diseases; Nervous System Diseases; Meningitis; Neuroinflammatory Diseases

Study Officials

• Jennifer C Moïsi, PhD

  Agence de Médecine Préventive

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Makawa-Sy Makawa, MD

CONTACT

+228-921 29 31; makmaksy@yahoo.fr

Haoua Tall, PharmD MPH

CONTACT

+226-50300406; htall@aamp.org

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 4, 2011
• First Posted: December 11, 2012
• Study Start: April 1, 2010
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2017
• Last Updated: March 6, 2017

Record last verified: 2017-03

Locations

TO (5)