Prevalence of Histoplasmosis in HIV + Patients with a Rapid Diagnostic Test in West Indies

NCT ID: NCT01884779

Last Updated: 2024-09-03

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 727 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-08-31
• Study Completion Date: 2015-11-03

Brief Summary

Histoplasma capsulatum var. capsulatum histoplasmosis is the leading cause of acquired immunodeficiency syndrome (AIDS) and death in French Guiana and probably in the Amazon. The diagnosis of this disease requires invasives procedures, laboratory performance, and delays up to several weeks. The Mycotic Diseases Branch of the Centers for Disease Control and Prevention (CDC) has established a rapid, sensitive and specific ELISA test for blood and urine samples that looks interesting in endemic areas, particularly in developing countries. The study aims to measure the proportion of HIV-infected patients hospitalized or in outpatient awaiting hospitalization for a suspicion of infectious syndrome whose serum and/or urinary antigen detection tests are positive for Histoplasma capsulatum var. capsulatum.

Conditions

HIV

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: CROSS_SECTIONAL

Eligibility Criteria

Inclusion Criteria

• Adult (aged 18 or over).
• Patient seen while hospitalized or in outpatient awaiting hospitalization.
• HIV1 or HIV2 infection confirmed by techniques validated in France and in Suriname, either before the episode considered, or discovered concomitantly.
• Patient presenting at least one of the three followings items: an alteration of their general condition (with a grade 1 according to the WHO Performance Status scale) and/or a fever and/or symptoms suggestive of an infectious syndrome.
• Medical prescription for the collection of blood and urine specimens to test for an infectious agent within 7 days following admission to the hospital.
• Written consent to participate in the study obtained.

Exclusion Criteria

• Refusal to participate in the study.
• Patient in a critical condition that doesn't allow physicians to get an informed consent without a legal representative to represent him and sign a consent form for the patient participation in the study.
• Ongoing antifungal treatment or antifungal treatment stopped during the month preceding the inclusion date (topic antifungal therapy not considered at this point).
• Patient in detention at the time of admission to the hospital.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ANRS, Emerging Infectious Diseases

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mathieu NACHER, MD, PhD

Role: STUDY_CHAIR

CIE 802 Inserm / DGOS

Stephen G VREDEN, MD, PhD

Role: STUDY_CHAIR

Foundation for Scientific Research Suriname (SWOS)

Locations

Pointe-à-Pitre University Hospital

Pointe à Pitre, Guadeloupe, France

Cayenne General Hospital

Cayenne, Guyane, France

Western French Guiana Hospital

Saint-Laurent-du-Maroni, Guyane, France

Fort-de-France University Hospital

Fort-de-France, Martinique, France

's Lands Hospital

Paramaribo, Paramaribo District, Suriname

Academisch Ziekenhuis Paramaribo Hospital

Paramaribo, Paramaribo District, Suriname

Diakonessenhuis hospital

Paramaribo, Paramaribo District, Suriname

Countries

France; Suriname

Other Identifiers

ANRS 12260 EDIRAPHIS

Identifier Type: -

Identifier Source: org_study_id