Clinical trial NCT01747369: Surveillance of Hospitalised Pneumonia and Bacterial Meningitis in Tône District, Togo, 2010-2013
Study type: OBSERVATIONAL
Overall status: UNKNOWN
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
Lead sponsor: Agence de Médecine Préventive, France
Sponsor class: OTHER
Collaborators: name: Region Sanitaire des Savanes, Togo
name: Ministere de la Sante et de la Promotion Sociale, Togo
name: Institut National d'Hygiene, Togo
name: Centre Muraz
name: Fondation Mérieux, France
name: Pfizer
First posted: 2012-12-11
Enrollment: 2000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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

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.


Eligibility 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

Primary outcomes:
measure: Incidence of pneumococcal pneumonia requiring hospitalisation, confirmed by blood culture or PCR analysis of blood
timeFrame: Subjects will be enrolled on admission to hospital and followed for the duration of hospitalization (median duration 6 days)
measure: Incidence of pneumococcal meningitis, confirmed by culture or PCR on cerebro-spinal fluid
timeFrame: Subjects will be enrolled on admission to hospital and followed for the duration of hospitalization (median duration 6 days)
Secondary outcomes:
measure: Incidence of radiologically confirmed pneumonia requiring hospitalisation
timeFrame: Subjects will be enrolled on admission to hospital and followed for the duration of hospitalization (median duration 6 days)
measure: Incidence of suspected pneumonia requiring hospitalisation with elevated C-reactive protein serum concentration (<40mg/l)
timeFrame: Subjects will be enrolled on admission to hospital and followed for the duration of hospitalization (median duration 6 days)
measure: Incidence of suspected pneumonia requiring hospitalisation with reduced oxygen saturation (<90%)
timeFrame: Subjects will be enrolled on admission to hospital and followed for the duration of hospitalization (median duration 6 days)
measure: Incidence of pneumonia of other bacterial or viral etiology requiring hospitalisation
timeFrame: Subjects will be enrolled on admission to hospital and followed for the duration of hospitalization (median duration 6 days)
measure: Incidence of acute meningitis of other bacterial etiology
timeFrame: Subjects will be enrolled on admission to hospital and followed for the duration of hospitalization (median duration 6 days)
Other outcomes:
Locations:
city: Cinkassé
country: Togo
facility: Centre médico-social (CMS)
state: Savanes region
city: Dapaong
country: Togo
facility: Centre Hospitalier Régional (CHR) Savanes
state: Savanes region
city: Dapaong
country: Togo
facility: Clinique Win' Pang
state: Savanes region
city: Dapaong
country: Togo
facility: Hôpital d'enfants Yendubé
state: Savanes region
city: Dapaong
country: Togo
facility: Polyclinique
state: Savanes region
Study officials:
affiliation: Agence de Médecine Préventive
name: Jennifer C Moïsi, PhD
role: PRINCIPAL_INVESTIGATOR
References: