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Trial record 1 of 1 for:    NCT01747369
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Surveillance of Hospitalised Pneumonia and Bacterial Meningitis in Tône District, Togo, 2010-2013

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ClinicalTrials.gov Identifier: NCT01747369
Recruitment Status : Unknown
Verified March 2017 by Agence de Médecine Préventive, France.
Recruitment status was:  Recruiting
First Posted : December 11, 2012
Last Update Posted : March 6, 2017
Sponsor:
Collaborators:
Region Sanitaire des Savanes, Togo
Ministere de la Sante et de la Promotion Sociale, Togo
Institut National d'Hygiene, Togo
Centre Muraz
Fondation Mérieux, France
Pfizer
Information provided by (Responsible Party):
Agence de Médecine Préventive, France

Tracking Information
First Submitted Date July 4, 2011
First Posted Date December 11, 2012
Last Update Posted Date March 6, 2017
Actual Study Start Date April 2010
Estimated Primary Completion Date June 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 10, 2012)
  • 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) ]
  • 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) ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: December 10, 2012)
  • 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) ]
  • 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) ]
  • 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) ]
  • 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) ]
  • 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) ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Surveillance of Hospitalised Pneumonia and Bacterial Meningitis in Tône District, Togo, 2010-2013
Official Title Not Provided
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Whole blood, cerebro-spinal fluid, nasal aspirate
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

Condition
  • Pneumonia, Bacterial
  • Pneumonia, Viral
  • Meningitis, Bacterial
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: December 10, 2012)
2000
Original Estimated Enrollment Same as current
Estimated Study Completion Date June 2017
Estimated Primary Completion Date June 2017   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Togo
Removed Location Countries  
 
Administrative Information
NCT Number NCT01747369
Other Study ID Numbers PneumoTone
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Agence de Médecine Préventive, France
Study Sponsor Agence de Médecine Préventive, France
Collaborators
  • Region Sanitaire des Savanes, Togo
  • Ministere de la Sante et de la Promotion Sociale, Togo
  • Institut National d'Hygiene, Togo
  • Centre Muraz
  • Fondation Mérieux, France
  • Pfizer
Investigators
Principal Investigator: Jennifer C Moïsi, PhD Agence de Médecine Préventive
PRS Account Agence de Médecine Préventive, France
Verification Date March 2017