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Register:	ClinicalTrials.gov
Last refreshed on:	16 December 2017
Main ID:	NCT01884779
Date of registration:	20/06/2013
Prospective Registration:	Yes
Primary sponsor:	French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
Public title:	Prevalence of Histoplasmosis in HIV + Patients With a Rapid Diagnostic Test in West Indies EDIRAPHIS
Scientific 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.
Date of first enrolment:	August 2013
Target sample size:	727
Recruitment status:	Active, not recruiting
URL:	https://clinicaltrials.gov/show/NCT01884779
Study type:	Observational [Patient Registry]
Study design:
Phase:	N/A

Countries of recruitment
France	Suriname

Contacts

Name:	Stephen G VREDEN, MD, PhD
Address:
Telephone:
Email:
Affiliation:	Foundation for Scientific Research Suriname (SWOS)

Name:	Mathieu NACHER, MD, PhD
Address:
Telephone:
Email:
Affiliation:	CIE 802 Inserm / DGOS

Key inclusion & exclusion 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.

Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

HIV

Intervention(s)

Primary Outcome(s)

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)]

Secondary Outcome(s)

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]

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)]

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]

Sensitivity of the ELISA test on urine and blood specimens [Time Frame: 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 [Time Frame: 30 days or 90 days after inclusion]

Sensibility of the ELISA test on urine and blood specimens [Time Frame: At the time of inclusion (baseline)]

Negative predictive value of the ELISA test on urine and blood specimens [Time Frame: At the time of inclusion (baseline)]

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]

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]

Secondary ID(s)

ANRS 12260 EDIRAPHIS

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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