NCT02128139

Brief 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)

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2012

Typical duration for all trials

Geographic Reach
5 countries

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2012

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

December 17, 2013

Completed
5 months until next milestone

First Posted

Study publicly available on registry

May 1, 2014

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

May 22, 2025

Status Verified

May 1, 2025

Enrollment Period

3 years

First QC Date

December 17, 2013

Last Update Submit

May 19, 2025

Conditions

Infective Endocarditis

Keywords

Infective endocarditisDeveloping countryGlobal healthCardiac surgeryHeart valve diseaseBacteremia

Outcome Measures

Primary Outcomes (1)

  • Mortality at 1 month follow-up

    1 month

Secondary Outcomes (1)

  • Mortality at 6 months follow-up

    6 months

Other Outcomes (1)

  • Access to cardiac surgery

    6 months

Eligibility Criteria

Age1 Year+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Hospital-based population.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Joseph Kado

Suva, Fiji

Location

Paul N. Newton

Vientiane, Laos

Location

Beatriz Ferreira

Maputo, Mozambique

Location

Abdul Kane

Dakar, Senegal

Location

Bara Diop

Dakar, Senegal

Location

Emmy Okello

Kampala, Uganda

Location

MeSH Terms

Conditions

EndocarditisHeart Valve DiseasesBacteremia

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesBacterial InfectionsBacterial Infections and MycosesInfectionsSepsisSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 17, 2013

First Posted

May 1, 2014

Study Start

April 1, 2012

Primary Completion

April 1, 2015

Study Completion

October 1, 2015

Last Updated

May 22, 2025

Record last verified: 2025-05

Locations

SE(2)UG(1)FI(1)LA(1)MO(1)