Prevalence of Histoplasmosis in HIV + Patients With a Rapid Diagnostic Test in West Indies (EDIRAPHIS)

Histoplasmosis in the Guiana Shield and the French West Indies: Evaluating Prevalence in HIV + Patients With a Rapid Diagnostic Test Using an ELISA Capture Method for the Detection of Histoplasma Antigens in Blood and Urine.

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.

Study Overview

• Status: Unknown
• Conditions: HIV

• Study Type: Observational
• Enrollment (Anticipated): 727

Contacts and Locations

Study Locations

• France
  • Guadeloupe
    • Pointe-à-Pitre, Guadeloupe, France, 97159
      • Pointe-à-Pitre University Hospital
  • Guyane
    • Cayenne, Guyane, France, 97306
      • Cayenne General Hospital
    • Saint-Laurent-du-Maroni, Guyane, France, 97320
      • Western French Guiana Hospital
  • Martinique
    • Fort-de-France, Martinique, France, 97261
      • Fort-de-France University Hospital
• Suriname
  • Paramaribo, Suriname
    • 's Lands Hospital
  • Paramaribo, Suriname
    • Academisch Ziekenhuis Paramaribo Hospital
  • Paramaribo, Suriname
    • Diakonessenhuis hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adult (aged 18 or over), 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, and 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.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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.	At the time of inclusion (baseline)

Secondary Outcome Measures

Outcome Measure	Time Frame
Sensitivity of the ELISA test on urine and blood specimens	At the time of inclusion (baseline)
Sensibility of the ELISA test on urine and blood specimens	At the time of inclusion (baseline)
Negative predictive value of the ELISA test on urine and blood specimens	At the time of inclusion (baseline)
Comparison of the distribution of Histoplasma antigen concentrations in urine and serum specimens according to severity of cases of histoplasmosis due to Histoplasma capsulatum var. capsulatum	At the time of inclusion (baseline)
Comparison of the socio-demographic, clinical, paraclinical and therapeutic characteristics according to severity of cases of histoplasmosis due to Histoplasma capsulatum var. capsulatum	30 days or 90 days after inclusion
Comparison of the factors for environmental exposure to Histoplasma capsulatum var capsulatum between patients with a positive ELISA test and/or fungal culture for histoplasmosis and those who tested negative for histoplasmosis	At the time of inclusion
Frequency of histoplasmosis compared to the other main diagnoses according to three sets of comparisons: positive ELISA test and positive fungal culture; positive ELISA test and negative fungal culture; negative ELISA test and positive fungal culture	90 days after inclusion
Comparison of the socio-demographic, clinical, paraclinical, therapeutic and survival outcome characteristics of cases of histoplasmosis compared to those who tested negative for histoplasmosis	90 days after inclusion
Identify the prognostic factors for short-term unfavourable progression of cases of histoplasmosis due to Histoplasma capsulatum var. capsulatum confirmed by ELISA test and/or by fungal culture	30 days and 90 days after inclusion

Collaborators and Investigators

• Sponsor: ANRS, Emerging Infectious Diseases
• Investigators: Study Chair: Mathieu NACHER, MD, PhD, CIE 802 Inserm / DGOS; Study Chair: Stephen G VREDEN, MD, PhD, Foundation for Scientific Research Suriname (SWOS)

Study record dates

Study Major Dates

• Study Start: August 1, 2013
• Primary Completion (Actual): July 1, 2014
• Study Completion (Anticipated): December 1, 2018

Study Registration Dates

• First Submitted: June 20, 2013
• First Submitted That Met QC Criteria: June 21, 2013
• First Posted (Estimate): June 24, 2013

Study Record Updates

• Last Update Posted (Actual): July 11, 2017
• Last Update Submitted That Met QC Criteria: July 10, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Keywords: HIV; Histoplasmosis; Histoplasma capsulatum var.capsulatum; ELISA test
• Additional Relevant MeSH Terms: Infections; Bacterial Infections and Mycoses; Mycoses; Histoplasmosis
• Other Study ID Numbers: ANRS 12260 EDIRAPHIS

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No