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

HIV Clinical Trial

— EDIRAPHIS  

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.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01884779
• Other study ID #: ANRS 12260 EDIRAPHIS
• Status: Active, not recruiting
• Phase: N/A
• First received: June 20, 2013
• Last updated: July 10, 2017
• Start date: August 2013
• Est. completion date: December 2018

Study information

• Verified date: July 2017
• Source: French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 727
• Est. completion date: December 2018
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Histoplasmosis
• HIV

Locations

Country	Name	City	State
France	Cayenne General Hospital	Cayenne	Guyane
France	Fort-de-France University Hospital	Fort-de-France	Martinique
France	Pointe-à-Pitre University Hospital	Pointe-à-Pitre	Guadeloupe
France	Western French Guiana Hospital	Saint-Laurent-du-Maroni	Guyane
Suriname	's Lands Hospital	Paramaribo
Suriname	Academisch Ziekenhuis Paramaribo Hospital	Paramaribo
Suriname	Diakonessenhuis hospital	Paramaribo

Sponsors (1)

Lead Sponsor	Collaborator
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)

Countries where clinical trial is conducted

France,  Suriname, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Sensitivity of the ELISA test on urine and blood specimens		At the time of inclusion (baseline)
Secondary	Sensibility of the ELISA test on urine and blood specimens		At the time of inclusion (baseline)
Secondary	Negative predictive value of the ELISA test on urine and blood specimens		At the time of inclusion (baseline)
Secondary	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)
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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