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NCT Number: NCT01884779

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

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.

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Key information

Conditions

HIV Bacterial Infections and Mycoses Histoplasmosis Infections Mycoses

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Pointe-à-Pitre University Hospital, Pointe à Pitre, Guadeloupe, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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.

    Time frame: At the time of inclusion (baseline)

Secondary outcomes

  1. Sensitivity of the ELISA test on urine and blood specimens

    Time frame: At the time of inclusion (baseline)

  2. Sensibility of the ELISA test on urine and blood specimens

    Time frame: At the time of inclusion (baseline)

  3. Negative predictive value of the ELISA test on urine and blood specimens

    Time frame: At the time of inclusion (baseline)

  4. 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

    Time frame: At the time of inclusion (baseline)

  5. Comparison of the socio-demographic, clinical, paraclinical and therapeutic characteristics according to severity of cases of histoplasmosis due to Histoplasma capsulatum var. capsulatum

    Time frame: 30 days or 90 days after inclusion

  6. 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

    Time frame: At the time of inclusion

  7. 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

    Time frame: 90 days after inclusion

  8. Comparison of the socio-demographic, clinical, paraclinical, therapeutic and survival outcome characteristics of cases of histoplasmosis compared to those who tested negative for histoplasmosis

    Time frame: 90 days after inclusion

  9. 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

    Time frame: 30 days and 90 days after inclusion

Sponsors and collaborators

Lead sponsor

ANRS, Emerging Infectious Diseases

Other Gov

Registry information

Official study title

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.

Acronym: EDIRAPHIS

Important dates

Study start
2013
Primary completion
2014
Study completion
2015
First posted
Jun 24, 2013
Registry last updated
Sep 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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