Infective Endocarditis in Developing Countries, a Prospective, Observational, Multicentre Study (EndoDev)

May 19, 2025 updated by: Institut National de la Santé Et de la Recherche Médicale, France

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 Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

300

Contacts and Locations

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

Study Locations

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

Ages Eligible for Study

1 year and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Hospital-based population.

Description

Inclusion Criteria:

  • Patients aged over 1 year diagnosed with infective endocarditis according to the modified Duke criteria

Exclusion Criteria:

  • Already included for a previous episode of infective endocarditis (i.e., relapse or reinfection)

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

Outcome Measure
Time Frame
Mortality at 1 month follow-up
Time Frame: 1 month
1 month

Secondary Outcome Measures

Outcome Measure
Time Frame
Mortality at 6 months follow-up
Time Frame: 6 months
6 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Access to cardiac surgery
Time Frame: 6 months
Heart surgery is not available in many low-income countries. One of the objectives is to assess whether guidelines can be applied in low-secourced settings.
6 months

Collaborators and Investigators

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

Sponsor

Institut National de la Santé Et de la Recherche Médicale, France

Collaborators

Centers for Disease Control and Prevention
War Memorial Hospital
Oxford University Hospitals NHS Trust
Hospital Laquinitinie de Douala
Yaounde Central Hospital
Eduardo Mondlane University
Bafoussam Regional Hospital, Cameroon
Mulago Hospital, Uganda
National Hospital of Niamey
Fann Hospital, Senegal
Institute of Cardiology Abidjan
Hospital General De Douala
Centre National Hospitalier Universitaire de Pneumo-Phtisiologie de Cotonou, Benin
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
Laos Oxford Mahosot Wellcome Research Unit

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)

April 1, 2012

Primary Completion (Actual)

April 1, 2015

Study Completion (Actual)

October 1, 2015

Study Registration Dates

First Submitted

December 17, 2013

First Submitted That Met QC Criteria

April 30, 2014

First Posted (Estimated)

May 1, 2014

Study Record Updates

Last Update Posted (Actual)

May 22, 2025

Last Update Submitted That Met QC Criteria

May 19, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C12-37 / EndoDev
  • Cardiology and Development (Other Identifier: INSERM)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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