Infective EndocarditisEndoDevNCT02128139
Infective Endocarditis in Developing Countries, a Prospective, Observational, Multicentre Study
An observational study of Infective Endocarditis, run by Institut National de la Santé Et de la Recherche Médicale, France at 6 sites in 5 countries.
Trial summary
Introduction. Comprehensive data on infective endocarditis in developing countries are scarce. Objectives: Description of the characteristics (clinical and microbiological) and assessment of the outcomes of infective endocarditis in low-income countries. Methods : Prospective, Observational, Multicentre study. Read more about this study
- Who is it for?
- Ages 1 year and older
- Conditions the study is for
- Infective Endocarditis
- How many people
- 300 participants
- Where
- 6 sitesin 5 countries
- Study dates
- Apr 2012to Oct 2015
- 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 1 year and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Hospital-based population.
Who may be able to join
- Patients aged over 1 year diagnosed with infective endocarditis according to the modified Duke criteria
Who cannot join
- Already included for a previous episode of infective endocarditis (i.e., relapse or reinfection)
Trial locations and contacts
6 sites in 5 countries.
6 sites in 5 countries
Fiji1 site
Joseph Kado
Suva
About this study
Introduction. Comprehensive data on infective endocarditis in developing countries are scarce.
Objectives: Description of the characteristics (clinical and microbiological) and assessment of the outcomes of infective endocarditis in low-income countries.
Read more
Methods : Prospective, Observational, Multicentre study. Inclusion criteria: patients aged over 1 year fulfilling the modified Duke criteria for infective endocarditis.
Exclusion criteria: patient included during a previous infective endocarditis episode.
Outcomes measures: Mortality at 6 months follow-up; mortality at 1 month follow-up; access to antibiotic treatment (modalities and duration), hospital length of stay and reason for discharge, and cardiac surgery when indicated.
Duration: One year (June 2014- June 2015)
- Conditions
- Infective Endocarditis
- Keywords
- Infective endocarditis, Developing country, Global health, Cardiac surgery, Heart valve disease, Bacteremia
- Medical subject headings
- Endocarditis, Heart Valve Diseases, Bacteremia
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality at 1 month follow-up
Measured: 1 month
Secondary outcomes (1)
Mortality at 6 months follow-up
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2014 (estimated)
- Study startApr 2012
- Primary completionApr 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infective EndocarditisStudies of the same condition, open and under way.
- More trials run by Institut National de la Santé Et de la Recherche Médicale, FranceThe sponsor's other registered studies.
- 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
- 300 participants (actual)
Sponsor and investigators
- Sponsor type
- Other government
- Collaborators
- War Memorial Hospital, Centers for Disease Control and Prevention, Oxford University Hospitals NHS Trust, St. Elizabeth Catholic General Hospital Shisong, Cameroun, CHU de Brazzaville, Congo Brazzaville, Polyclinique International de Bamako, Mali, CHR de Saint-Louis Lt Colonel Mamadou Diouf, Sénégal, Hôpital Général de Grand Yoff de Dakar, Sénégal, Bafoussam Regional Hospital, Cameroon, Hospital Laquinitinie de Douala, Yaounde Central Hospital, National Hospital of Niamey, Centre National Hospitalier Universitaire de Pneumo-Phtisiologie de Cotonou, Benin, Hospital General De Douala, Eduardo Mondlane University, Laos Oxford Mahosot Wellcome Research Unit, Mulago Hospital, Uganda, Fann Hospital, Senegal, Institute of Cardiology Abidjan
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02128139
- Sponsor's protocol ID
- C12-37 / EndoDev
- Other IDs
- Cardiology and Development
- Acronym
- EndoDev
- Status last verified
- May 2025
- First submitted
- 17 Dec 2013
- Last updated
- 22 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Infective Endocarditis in Developing Countries, a Prospective, Observational, Multicentre Study
- ClinicalTrials.gov ID
- NCT02128139
- Acronym / sponsor ID
- EndoDev / C12-37 / EndoDev
- Conditions
- Infective Endocarditis
- Keywords
- Infective endocarditis, Developing country, Global health, Cardiac surgery, Heart valve disease, Bacteremia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Institut National de la Santé Et de la Recherche Médicale, FranceOther government
- Collaborators
- War Memorial Hospital, Centers for Disease Control and Prevention, Oxford University Hospitals NHS Trust, St. Elizabeth Catholic General Hospital Shisong, Cameroun, CHU de Brazzaville, Congo Brazzaville, Polyclinique International de Bamako, Mali, CHR de Saint-Louis Lt Colonel Mamadou Diouf, Sénégal, Hôpital Général de Grand Yoff de Dakar, Sénégal, Bafoussam Regional Hospital, Cameroon, Hospital Laquinitinie de Douala, Yaounde Central Hospital, National Hospital of Niamey, Centre National Hospitalier Universitaire de Pneumo-Phtisiologie de Cotonou, Benin, Hospital General De Douala, Eduardo Mondlane University, Laos Oxford Mahosot Wellcome Research Unit, Mulago Hospital, Uganda, Fann Hospital, Senegal, Institute of Cardiology Abidjan
- Study start
- Apr 2012 (actual)
- Primary completion
- Apr 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 1 May 2014 (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.
Introduction. Comprehensive data on infective endocarditis in developing countries are scarce.
Objectives: Description of the characteristics (clinical and microbiological) and assessment of the outcomes of infective endocarditis in low-income countries.
Methods : Prospective, Observational, Multicentre study. Inclusion criteria: patients aged over 1 year fulfilling the modified Duke criteria for infective endocarditis.
Exclusion criteria: patient included during a previous infective endocarditis episode.
Outcomes measures: Mortality at 6 months follow-up; mortality at 1 month follow-up; access to antibiotic treatment (modalities and duration), hospital length of stay and reason for discharge, and cardiac surgery when indicated.
Duration: One year (June 2014- June 2015)
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 year and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Hospital-based population.
Key inclusion criteria (1 listed)
- Patients aged over 1 year diagnosed with infective endocarditis according to the modified Duke criteria
Key exclusion criteria (1 listed)
- Already included for a previous episode of infective endocarditis (i.e., relapse or reinfection)
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
Mortality at 1 month follow-up
Time frame: 1 month
1 secondary outcome
Mortality at 6 months follow-up
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infective Endocarditis, run by Institut National de la Santé Et de la Recherche Médicale, France at 6 sites in 5 countries.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 22 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Senegal, Fiji, Laos, Mozambique, Uganda. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality at 1 month follow-up (time frame: 1 month). 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 22 May 2025.