Clinical Trials Logo

Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT01884779
Other study ID # ANRS 12260 EDIRAPHIS
Secondary ID
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Recruiting NCT06162897 - Case Management Dyad N/A
Completed NCT03999411 - Smartphone Intervention for Smoking Cessation and Improving Adherence to Treatment Among HIV Patients Phase 4
Completed NCT02528773 - Efficacy of ART to Interrupt HIV Transmission Networks
Recruiting NCT05454839 - Preferences for Services in a Patient's First Six Months on Antiretroviral Therapy for HIV in South Africa
Recruiting NCT05322629 - Stepped Care to Optimize PrEP Effectiveness in Pregnant and Postpartum Women N/A
Completed NCT02579135 - Reducing HIV Risk Among Adolescents: Evaluating Project HEART N/A
Active, not recruiting NCT01790373 - Evaluating a Youth-Focused Economic Empowerment Approach to HIV Treatment Adherence N/A
Not yet recruiting NCT06044792 - The Influence of Primary HIV-1 Drug Resistance Mutations on Immune Reconstruction in PLWH
Completed NCT04039217 - Antiretroviral Therapy (ART) Persistence in Different Body Compartments in HIV Negative MSM Phase 4
Active, not recruiting NCT04519970 - Clinical Opportunities and Management to Exploit Biktarvy as Asynchronous Connection Key (COMEBACK) N/A
Completed NCT04124536 - Combination Partner HIV Testing Strategies for HIV-positive and HIV-negative Pregnant Women N/A
Recruiting NCT05599581 - Tu'Washindi RCT: Adolescent Girls in Kenya Taking Control of Their Health N/A
Active, not recruiting NCT04588883 - Strengthening Families Living With HIV in Kenya N/A
Completed NCT02758093 - Speed of Processing Training in Adults With HIV N/A
Completed NCT02500446 - Dolutegravir Impact on Residual Replication Phase 4
Completed NCT03805451 - Life Steps for PrEP for Youth N/A
Active, not recruiting NCT03902431 - Translating the ABCS Into HIV Care N/A
Completed NCT00729391 - Women-Focused HIV Prevention in the Western Cape Phase 2/Phase 3
Recruiting NCT05736588 - Elimisha HPV (Human Papillomavirus) N/A
Recruiting NCT03589040 - Darunavir and Rilpivirine Interactions With Etonogestrel Contraceptive Implant Phase 2