Infective Endocarditis in Developing Countries, a Prospec... | NCT02128139

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

NCT02128139

Sponsor

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

Status

Completed

Last Update Posted

May 22, 2025Actual

Enrollment

300Actual

Phase

Not provided

Conditions

Infective Endocarditis

Interventions

Not provided

Countries

Fiji
Laos
Mozambique
Senegal
Uganda

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
Cardiology and Development	Other Identifier	INSERM

Status Module

Record Verification Date

May 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2012Actual

Primary Completion Date

Apr 2015Actual

Completion Date

Oct 2015Actual

First Submitted Date

Dec 17, 2013

First Submission Date that Met QC Criteria

Apr 30, 2014

First Posted Date

May 1, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 19, 2025

Last Update Posted Date

May 22, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Sponsor

Lead Sponsor

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

Collaborators

Name	Class
War Memorial Hospital	OTHER
Centers for Disease Control and Prevention	FED
Oxford University Hospitals NHS Trust	OTHER
St. Elizabeth Catholic General Hospital Shisong, Cameroun

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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)

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

300Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Mortality at 1 month follow-up		1 month

Secondary Outcomes

Measure	Description	Time Frame
Mortality at 6 months follow-up		6 months

Other Outcomes

Measure	Description	Time Frame
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.	6 months

Eligibility Module

Eligibility Criteria

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)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Year

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Hospital-based population.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Joseph Kado		Suva			Fiji
Paul N. Newton

Condition Browse Module

MeSH Terms

ID	Term
D004696	Endocarditis
D006349	Heart Valve Diseases
D016470	Bacteremia

Ancestor Terms

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D001424	Bacterial Infections
D001423	Bacterial Infections and Mycoses

Browse Leaves

Not provided

Browse Branches

Not provided