Surveillance of Hospitalised Pneumonia and Bacterial Meningitis in Tône District, Togo, 2010-2013
This study is currently recruiting participants.
Verified December 2012 by Agence de Médecine Préventive, France
Sponsor:
Agence de Médecine Préventive, France
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
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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
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:
|
Meningitis Meningitis, Bacterial Pneumonia, Bacterial Pneumonia Pneumonia, Viral 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 June 18, 2013