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Infective Endocarditis in Developing Countries, a Prospective, Observational, Multicentre Study (EndoDev)

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ClinicalTrials.gov Identifier: NCT02128139
Recruitment Status : Unknown
Verified April 2014 by Institut National de la Santé Et de la Recherche Médicale, France.
Recruitment status was:  Not yet recruiting
First Posted : May 1, 2014
Last Update Posted : May 1, 2014
Sponsor:
Collaborators:
Ministry of Health, Mozambique
War Memorial Hospital
Centers for Disease Control and Prevention
Oxford University Hospitals NHS Trust
Information provided by (Responsible Party):
Institut National de la Santé Et de la Recherche Médicale, France

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)


Condition or disease
Infective Endocarditis

Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Infective Endocarditis in Developing Countries, a Prospective, Observational, Multicentre Study
Study Start Date : June 2014
Estimated Primary Completion Date : June 2015
Estimated Study Completion Date : June 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endocarditis
U.S. FDA Resources




Primary Outcome Measures :
  1. Mortality at 1 month follow-up [ Time Frame: 1 month ]

Secondary Outcome Measures :
  1. Mortality at 6 months follow-up [ Time Frame: 6 months ]

Other Outcome Measures:
  1. Access to cardiac surgery [ Time Frame: 6 months ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Hospital-based population.
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02128139


Contacts
Contact: Mariana S Mirabel, MD +33153988000 mariana.mirabel@inserm.fr
Contact: Eloi Marijon, MD +33153988000 eloi.marijon@inserm.fr

Locations
Fiji
Joseph Kado Not yet recruiting
Suva, Fiji
Contact       jkado@health.gov.fj   
Lao People's Democratic Republic
Paul N. Newton Not yet recruiting
Vientiane, Lao People's Democratic Republic
Contact: Paul N Newton, MD       paul@tropmedres.ac   
Mozambique
Beatriz Ferreira Not yet recruiting
Maputo, Mozambique
Contact       beatriz@tvcabo.co.mz   
Senegal
Abdul Kane Not yet recruiting
Dakar, Senegal
Contact       abdoul_kane@hotmail.com   
Bara Diop Not yet recruiting
Dakar, Senegal
Contact       ibdsb@orange.sn‬   
Uganda
Emmy Okello Not yet recruiting
Kampala, Uganda
Contact       emmkol@hotmail.com   
Sponsors and Collaborators
Institut National de la Santé Et de la Recherche Médicale, France
Ministry of Health, Mozambique
War Memorial Hospital
Centers for Disease Control and Prevention
Oxford University Hospitals NHS Trust

Additional Information:
Responsible Party: Institut National de la Santé Et de la Recherche Médicale, France
ClinicalTrials.gov Identifier: NCT02128139     History of Changes
Other Study ID Numbers: EndoDev
Cardiology and Development ( Other Identifier: INSERM )
First Posted: May 1, 2014    Key Record Dates
Last Update Posted: May 1, 2014
Last Verified: April 2014

Keywords provided by Institut National de la Santé Et de la Recherche Médicale, France:
Infective endocarditis
Developing country
Global health
Cardiac surgery
Heart valve disease
Bacteremia

Additional relevant MeSH terms:
Endocarditis
Endocarditis, Bacterial
Heart Diseases
Cardiovascular Diseases
Bacterial Infections
Cardiovascular Infections
Infection