Clinical trial NCT01884779: Prevalence of Histoplasmosis in HIV + Patients with a Rapid Diagnostic Test in West Indies
Official 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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV
Keywords: HIV
Histoplasmosis
Histoplasma capsulatum var.capsulatum
ELISA test
Lead sponsor: ANRS, Emerging Infectious Diseases
Sponsor class: OTHER_GOV
First posted: 2013-06-24
Enrollment: 727
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
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.

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.


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.

Primary outcomes:
measure: 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.
timeFrame: At the time of inclusion (baseline)
Secondary outcomes:
measure: Sensitivity of the ELISA test on urine and blood specimens
timeFrame: At the time of inclusion (baseline)
measure: Sensibility of the ELISA test on urine and blood specimens
timeFrame: At the time of inclusion (baseline)
measure: Negative predictive value of the ELISA test on urine and blood specimens
timeFrame: At the time of inclusion (baseline)
measure: 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
timeFrame: At the time of inclusion (baseline)
measure: Comparison of the socio-demographic, clinical, paraclinical and therapeutic characteristics according to severity of cases of histoplasmosis due to Histoplasma capsulatum var. capsulatum
timeFrame: 30 days or 90 days after inclusion
measure: 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
timeFrame: At the time of inclusion
measure: 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
timeFrame: 90 days after inclusion
measure: Comparison of the socio-demographic, clinical, paraclinical, therapeutic and survival outcome characteristics of cases of histoplasmosis compared to those who tested negative for histoplasmosis
timeFrame: 90 days after inclusion
measure: 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
timeFrame: 30 days and 90 days after inclusion
Other outcomes:
Locations:
city: Pointe-à-Pitre
country: France
facility: Pointe-à-Pitre University Hospital
state: Guadeloupe
city: Cayenne
country: France
facility: Cayenne General Hospital
state: Guyane
city: Saint-Laurent-du-Maroni
country: France
facility: Western French Guiana Hospital
state: Guyane
city: Fort-de-France
country: France
facility: Fort-de-France University Hospital
state: Martinique
city: Paramaribo
country: Suriname
facility: 's Lands Hospital
city: Paramaribo
country: Suriname
facility: Academisch Ziekenhuis Paramaribo Hospital
city: Paramaribo
country: Suriname
facility: Diakonessenhuis hospital
Study officials:
affiliation: CIE 802 Inserm / DGOS
name: Mathieu NACHER, MD, PhD
role: STUDY_CHAIR
affiliation: Foundation for Scientific Research Suriname (SWOS)
name: Stephen G VREDEN, MD, PhD
role: STUDY_CHAIR
References: