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CompletedNCT02128139EndoDevUpdated May 22, 2025

Infective Endocarditis in Developing Countries, a Prospective, Observational, Multicentre Study

An observational study in Infective Endocarditis, sponsored by Institut National de la Santé Et de la Recherche Médicale, France. Completed at 6 sites in 5 countries. Open to participants aged 1 Year and older. Per ClinicalTrials.gov, last updated 2025-05-22.

Sponsored by Institut National de la Santé Et de la Recherche Médicale, France · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
300
Ages
1 Year and older
Sex
All
01

Study 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. 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)

02

Conditions studied

  • Infective Endocarditis

Keywords

  • Infective endocarditis
  • Developing country
  • Global health
  • Cardiac surgery
  • Heart valve disease
  • Bacteremia
03

In context

Endocarditis

173 studies on the registry are indexed under Endocarditis; 57 are open to participants now.

This study's enrollment of 300 is above the median of 225 across 82 observational studies indexed under Endocarditis.

Browse Endocarditis studies →

Lead sponsor

Institut National de la Santé Et de la Recherche Médicale, France is the lead sponsor of 378 studies on the registry; 81 are open to participants now.

Browse Institut National de la Santé Et de la Recherche Médicale, France studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Year and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Hospital-based population.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Already included for a previous episode of infective endocarditis (i.e., relapse or reinfection)
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
300 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Mortality at 1 month follow-up

    Time frame: 1 month

Secondary outcomes

  1. Mortality at 6 months follow-up

    Time frame: 6 months

Other outcomes

  1. Access to cardiac surgery

    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.

    Time frame: 6 months

07

Study locations

6 sites
  • Joseph Kado
    Suva, Fiji
  • Paul N. Newton
    Vientiane, Lao People's Democratic Republic
  • Beatriz Ferreira
    Maputo, Mozambique
  • Abdul Kane
    Dakar, Senegal
  • Bara Diop
    Dakar, Senegal
  • Emmy Okello
    Kampala, Uganda
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Apr 2012 to primary completion in Apr 2015, 36 months.

Of 36 observational studies under Endocarditis, half reached primary completion within 62 months of starting (the median), counting those still running; a quarter within 36. This study's 36 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 17, 2013
First posted
May 1, 2014
StartActual
Apr 2012
Primary completionActual
Apr 2015
CompletionActual
Oct 2015
Last update
May 22, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 22, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02128139
Lead sponsor
Institut National de la Santé Et de la Recherche Médicale, France
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
First posted
May 1, 2014
Start date
Apr 2012
Primary completion
Apr 2015
Completion
Oct 2015
Last update
May 22, 2025

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2025. You cannot join it, but the record below documents what was studied.

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Discussion

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