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

Infective Endocarditis Clinical Trial

— EndoDev  

Official title:

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

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

Related Conditions & MeSH terms

• Endocarditis
• Endocarditis, Bacterial
• Infective Endocarditis

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

External Links

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