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

March 3, 2017 updated by: Agence de Médecine Préventive, France
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
2000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: Haoua Tall, PharmD MPH
  • Phone Number: +226-50300406
  • Email: htall@aamp.org

Study Locations

  • Togo
    • Savanes region
      • Cinkassé, Savanes region, Togo
        • Recruiting
        • Centre médico-social (CMS)
      • Dapaong, Savanes region, Togo
        • Recruiting
        • Centre Hospitalier Régional (CHR) Savanes
      • Dapaong, Savanes region, Togo
        • Recruiting
        • Clinique Win' Pang
      • Dapaong, Savanes region, Togo
        • Recruiting
        • Hôpital d'enfants Yendubé
      • Dapaong, Savanes region, Togo
        • Recruiting
        • Polyclinique

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
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)
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)
Subjects will be enrolled on admission to hospital and followed for the duration of hospitalization (median duration 6 days)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
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)
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)
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)
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)
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)
Subjects will be enrolled on admission to hospital and followed for the duration of hospitalization (median duration 6 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Agence de Médecine Préventive, France

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Pfizer
Centre Muraz
Region Sanitaire des Savanes, Togo
Ministere de la Sante et de la Promotion Sociale, Togo
Institut National d'Hygiene, Togo
Fondation Mérieux, France

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jennifer C Moïsi, PhD, Agence de Médecine Préventive

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2010

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2017

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 4, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 10, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 11, 2012

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 6, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 3, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PneumoTone

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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