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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
ClinicalTrials.gov Identifier:
NCT01884779
First received: June 20, 2013
Last updated: April 5, 2016
Last verified: April 2016
  Purpose
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.

Condition
HIV

Study Type: Observational [Patient Registry]
Study Design: Time Perspective: Cross-Sectional
Target Follow-Up Duration: 90 Days
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.

Resource links provided by NLM:


Further study details as provided by French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS):

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Sensitivity of the ELISA test on urine and blood specimens [ Time Frame: At the time of inclusion (baseline) ] [ Designated as safety issue: No ]
  • Sensibility of the ELISA test on urine and blood specimens [ Time Frame: At the time of inclusion (baseline) ] [ Designated as safety issue: No ]
  • Negative predictive value of the ELISA test on urine and blood specimens [ Time Frame: At the time of inclusion (baseline) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA
Urine, serum and Histoplasma capsulatum var. capsulatum strains

Estimated Enrollment: 727
Study Start Date: August 2013
Estimated Study Completion Date: October 2016
Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01884779

Locations
France
Pointe-à-Pitre University Hospital
Pointe-à-Pitre, Guadeloupe, France, 97159
Cayenne General Hospital
Cayenne, Guyane, France, 97306
Western French Guiana Hospital
Saint-Laurent-du-Maroni, Guyane, France, 97320
Fort-de-France University Hospital
Fort-de-France, Martinique, France, 97261
Suriname
's Lands Hospital
Paramaribo, Suriname
Academisch Ziekenhuis Paramaribo Hospital
Paramaribo, Suriname
Diakonessenhuis hospital
Paramaribo, Suriname
Sponsors and Collaborators
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
Investigators
Study Chair: Mathieu NACHER, MD, PhD CIE 802 Inserm / DGOS
Study Chair: Stephen G VREDEN, MD, PhD Foundation for Scientific Research Suriname (SWOS)
  More Information

Responsible Party: French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
ClinicalTrials.gov Identifier: NCT01884779     History of Changes
Other Study ID Numbers: ANRS 12260 EDIRAPHIS 
Study First Received: June 20, 2013
Last Updated: April 5, 2016
Health Authority: Suriname:Ministerie van Volksgezondheid
France: Committee for the Protection of Personnes

Keywords provided by French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS):
HIV
Histoplasmosis
Histoplasma capsulatum var.capsulatum
ELISA test

Additional relevant MeSH terms:
Histoplasmosis
Mycoses

ClinicalTrials.gov processed this record on May 26, 2016