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

NCT01884779 | Completed DMC

• 1 other identifier: ANRS 12260 EDIRAPHIS
• Study Type: observational
• Target: 727
• Locations: 2 countries
• Sites: 7

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

Keywords

HIV; Histoplasmosis; Histoplasma capsulatum var.capsulatum; ELISA test

Outcome Measures

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.

  At the time of inclusion (baseline)

Secondary Outcomes (9)

• 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Patient in detention at the time of admission to the hospital.

Sponsors & Collaborators

• ANRS, Emerging Infectious Diseases: lead

Study Sites (7)

Pointe-à-Pitre University Hospital

Pointe à Pitre, Guadeloupe, 97159, France

Location

Cayenne General Hospital

Cayenne, Guyane, 97306, France

Location

Western French Guiana Hospital

Saint-Laurent-du-Maroni, Guyane, 97320, France

Location

Fort-de-France University Hospital

Fort-de-France, Martinique, 97261, France

Location

's Lands Hospital

Paramaribo, Paramaribo District, Suriname

Location

Academisch Ziekenhuis Paramaribo Hospital

Paramaribo, Paramaribo District, Suriname

Location

Diakonessenhuis hospital

Paramaribo, Paramaribo District, Suriname

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Urine, serum and Histoplasma capsulatum var. capsulatum strains

MeSH Terms

Conditions

Histoplasmosis

Condition Hierarchy (Ancestors)

Mycoses; Bacterial Infections and Mycoses; Infections

Study Officials

• Mathieu NACHER, MD, PhD

  CIE 802 Inserm / DGOS

  STUDY CHAIR

• Stephen G VREDEN, MD, PhD

  Foundation for Scientific Research Suriname (SWOS)

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Target Duration: 90 Days
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2013
• First Posted: June 24, 2013
• Study Start: August 1, 2013
• Primary Completion: July 1, 2014
• Study Completion: November 3, 2015
• Last Updated: September 3, 2024

Record last verified: 2017-07

Locations

FR (4); SU (3)