Clinical trial NCT02128139: Infective Endocarditis in Developing Countries, a Prospective, Observational, Multicentre Study
Official title: Infective Endocarditis in Developing Countries, a Prospective, Observational, Multicentre Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infective Endocarditis
Keywords: Infective endocarditis
Developing country
Global health
Cardiac surgery
Heart valve disease
Bacteremia
Lead sponsor: Institut National de la Santé Et de la Recherche Médicale, France
Sponsor class: OTHER_GOV
Collaborators: name: War Memorial Hospital
name: Centers for Disease Control and Prevention
name: Oxford University Hospitals NHS Trust
name: St. Elizabeth Catholic General Hospital Shisong, Cameroun
name: CHU de Brazzaville, Congo Brazzaville
name: Polyclinique International de Bamako, Mali
name: CHR de Saint-Louis Lt Colonel Mamadou Diouf, Sénégal
name: Hôpital Général de Grand Yoff de Dakar, Sénégal
name: Bafoussam Regional Hospital, Cameroon
name: Hospital Laquinitinie de Douala
name: Yaounde Central Hospital
name: National Hospital of Niamey
name: Centre National Hospitalier Universitaire de Pneumo-Phtisiologie de Cotonou, Benin
name: Hospital General De Douala
name: Eduardo Mondlane University
name: Laos Oxford Mahosot Wellcome Research Unit
name: Mulago Hospital, Uganda
name: Fann Hospital, Senegal
name: Institute of Cardiology Abidjan
First posted: 2014-05-01
Enrollment: 300
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hospital-based population.

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)


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)

Primary outcomes:
measure: Mortality at 1 month follow-up
timeFrame: 1 month
Secondary outcomes:
measure: Mortality at 6 months follow-up
timeFrame: 6 months
Other outcomes:
measure: Access to cardiac surgery
timeFrame: 6 months
Locations:
city: Suva
country: Fiji
facility: Joseph Kado
city: Vientiane
country: Lao People's Democratic Republic
facility: Paul N. Newton
city: Maputo
country: Mozambique
facility: Beatriz Ferreira
city: Dakar
country: Senegal
facility: Abdul Kane
city: Dakar
country: Senegal
facility: Bara Diop
city: Kampala
country: Uganda
facility: Emmy Okello
Study officials:
References: