Pneumonia, BacterialNCT01747369
Surveillance of Hospitalised Pneumonia and Bacterial Meningitis in Tône District, Togo, 2010-2013
An observational study of Pneumonia, Bacterial and Pneumonia, Viral, run by Agence de Médecine Préventive, France at 5 sites in Togo.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pneumonia, Bacterial, Pneumonia, Viral, Meningitis, Bacterial
- How many people
- 2,000 participants
- Where
- 5 sitesTogo
- Study dates
- Apr 2010to Jun 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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
Who may be able to join
- 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
- resident of Tône sanitary district
- presenting clinical signs of acute bacterial meningitis
- hospitalised in a study site during the study period
Who cannot join
- absence of informed consent by patient or legal tutor
- Meningitis surveillance:
- absence of informed consent by patient or legal tutor
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Togo5 sites, 5 recruiting
- Recruiting
Centre Hospitalier Régional (CHR) Savanes
Dapaong, Savanes
- Recruiting
Clinique Win' Pang
Dapaong, Savanes
- Recruiting
Hôpital d'enfants Yendubé
Dapaong, Savanes
- Recruiting
Polyclinique
Dapaong, Savanes
- Recruiting
Centre médico-social (CMS)
Sinkassé, Savanes
About this study
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.
- Keywords
- surveillance study, prospective, observational, health center-based, pneumonia, bacterial, pneumonia, viral, meningitis, bacterial, Africa south of the Sahara
- Medical subject headings
- Pneumonia, Bacterial, Pneumonia, Viral, Meningitis, Bacterial
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of pneumococcal pneumonia requiring hospitalisation, confirmed by blood culture or PCR analysis of blood
Measured: 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
Measured: 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
Measured: 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)
Measured: 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%)
Measured: 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
Measured: 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
Measured: Subjects will be enrolled on admission to hospital and followed for the duration of hospitalization (median duration 6 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2012 (estimated)
- Study startApr 2010
- Primary completionJun 2017 (estimated)
- Study completionJun 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pneumonia, BacterialStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Agence de Médecine Préventive, France
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Sponsor
- Investigators
- Jennifer C Moïsi, PhD, Principal investigator, Agence de Médecine Préventive
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01747369
- Sponsor's protocol ID
- PneumoTone
- Status last verified
- Mar 2017
- First submitted
- 4 Jul 2011
- Last updated
- 6 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surveillance of Hospitalised Pneumonia and Bacterial Meningitis in Tône District, Togo, 2010-2013
- ClinicalTrials.gov ID
- NCT01747369
- Acronym / sponsor ID
- PneumoTone
- Keywords
- surveillance study, prospective, observational, health center-based, pneumonia, bacterial, pneumonia, viral, meningitis, bacterial, Africa south of the Sahara
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Agence de Médecine Préventive, FranceUniversity, hospital or other
- 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
- Study start
- Apr 2010 (actual)
- Primary completion
- Jun 2017 (estimated)
- Study completion
- Jun 2017 (estimated)
- First posted
- 11 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (5 listed)
- 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
- resident of Tône sanitary district
- presenting clinical signs of acute bacterial meningitis
- hospitalised in a study site during the study period
Key exclusion criteria (3 listed)
- absence of informed consent by patient or legal tutor
- absence of informed consent by patient or legal tutor
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)
5 secondary outcomes
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2017.
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Pneumococcal Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer C Moïsi, PhD principal investigator
Agence de Médecine Préventive
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pneumonia, Bacterial and Pneumonia, Viral, run by Agence de Médecine Préventive, France at 5 sites in Togo.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Togo. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Makawa-Sy Makawa, MD (+228-921 29 31, makmaksy@yahoo.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2017.