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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 by French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
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: October 29, 2013
Last verified: October 2013

June 20, 2013
October 29, 2013
August 2013
July 2014   (final data collection date for primary outcome 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. [ Time Frame: At the time of inclusion (baseline) ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01884779 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Prevalence of Histoplasmosis in HIV + Patients With a Rapid Diagnostic Test in West Indies
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.

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.

Not Provided
Observational [Patient Registry]
Time Perspective: Cross-Sectional
90 Days
Retention:   Samples Without DNA
Description:

Urine, serum and Histoplasma capsulatum var. capsulatum strains

Non-Probability Sample

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.

HIV
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
727
July 2015
July 2014   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact: Mathieu NACHER, MD, PhD +594 594 39 50 24 mathieu.nacher@ch.cayenne.fr
Contact: Antoine ADENIS, MD, MPH +594 594 39 50 08 antoine.adenis@gmail.com
Suriname,   France
 
NCT01884779
ANRS 12260 EDIRAPHIS
Yes
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
Not Provided
Study Chair: Mathieu NACHER, MD, PhD CIE 802 Inserm / DGOS
Study Chair: Stephen G VREDEN, MD, PhD Foundation for Scientific Research Suriname (SWOS)
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP