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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT02128139
Other study ID # EndoDev
Secondary ID Cardiology and D
Status Not yet recruiting
Phase N/A
First received December 17, 2013
Last updated April 30, 2014
Start date June 2014
Est. completion date June 2015

Study information

Verified date April 2014
Source Institut National de la Santé Et de la Recherche Médicale, France
Contact Mariana S Mirabel, MD
Phone +33153988000
Email mariana.mirabel@inserm.fr
Is FDA regulated No
Health authority France: The Commission nationale de l’informatique et des libertés
Study type Observational

Clinical 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. 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)


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 500
Est. completion date June 2015
Est. primary completion date June 2015
Accepts healthy volunteers No
Gender Both
Age group 1 Year and older
Eligibility 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 Design

Observational Model: Case-Only, Time Perspective: Prospective


Locations

Country Name City State
Fiji Joseph Kado Suva
Lao People's Democratic Republic Paul N. Newton Vientiane
Mozambique Beatriz Ferreira Maputo
Senegal Abdul Kane Dakar
Senegal Bara Diop Dakar
Uganda Emmy Okello Kampala

Sponsors (5)

Lead Sponsor Collaborator
Institut National de la Santé Et de la Recherche Médicale, France Centers for Disease Control and Prevention, Ministry of Health, Mozambique, Oxford University Hospitals NHS Trust, War Memorial Hospital

Countries where clinical trial is conducted

Fiji,  Lao People's Democratic Republic,  Mozambique,  Senegal,  Uganda, 

Outcome

Type Measure Description Time frame Safety issue
Other 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 No
Primary Mortality at 1 month follow-up 1 month No
Secondary Mortality at 6 months follow-up 6 months No
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