HIVEDIRAPHISNCT01884779
Prevalence of Histoplasmosis in HIV + Patients with a Rapid Diagnostic Test in West Indies
An observational study of HIV, run by ANRS, Emerging Infectious Diseases at 7 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV
- How many people
- 727 participants
- Where
- 7 sitesin 2 countries
- Study dates
- Aug 2013to 3 Nov 2015
- How long will I take part?
- 90 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
7 sites in 2 countries.
7 sites in 2 countries
France4 sites
Cayenne General Hospital
Cayenne, Guyane, 97306
Fort-de-France University Hospital
Fort-de-France, Martinique, 97261
Pointe-à-Pitre University Hospital
Pointe à Pitre, Guadeloupe, 97159
Western French Guiana Hospital
Saint-Laurent-du-Maroni, Guyane, 97320
Suriname3 sites
's Lands Hospital
Paramaribo, Paramaribo District
Academisch Ziekenhuis Paramaribo Hospital
Paramaribo, Paramaribo District
Diakonessenhuis hospital
Paramaribo, Paramaribo District
About this study
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.
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
- Medical subject headings
- Histoplasmosis
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At the time of inclusion (baseline)
Secondary outcomes (9)
Sensitivity of the ELISA test on urine and blood specimens
Measured: At the time of inclusion (baseline)
Sensibility of the ELISA test on urine and blood specimens
Measured: At the time of inclusion (baseline)
Negative predictive value of the ELISA test on urine and blood specimens
Measured: 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
Measured: 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
Measured: 30 days or 90 days after inclusion
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
Measured: At the time of inclusion
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
Measured: 90 days after inclusion
Comparison of the socio-demographic, clinical, paraclinical, therapeutic and survival outcome characteristics of cases of histoplasmosis compared to those who tested negative for histoplasmosis
Measured: 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
Measured: 30 days and 90 days after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2013 (estimated)
- Study startAug 2013
- Primary completionJul 2014
- Study completion3 Nov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by ANRS, Emerging Infectious DiseasesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 727 participants (estimated)
- Target duration
- 90 Days
Sponsor and investigators
- Lead sponsor
- ANRS, Emerging Infectious Diseases
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Mathieu NACHER, MD, PhD, Study chair, CIE 802 Inserm / DGOSStephen G VREDEN, MD, PhD, Study chair, Foundation for Scientific Research Suriname (SWOS)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01884779
- Sponsor's protocol ID
- ANRS 12260 EDIRAPHIS
- Acronym
- EDIRAPHIS
- Status last verified
- Jul 2017
- First submitted
- 20 Jun 2013
- Last updated
- 3 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01884779
- Acronym / sponsor ID
- EDIRAPHIS / ANRS 12260 EDIRAPHIS
- Conditions
- HIV
- Keywords
- HIV, Histoplasmosis, Histoplasma capsulatum var.capsulatum, ELISA test
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 727 participants (estimated)
- Lead sponsor
- ANRS, Emerging Infectious DiseasesOther government
- Study start
- Aug 2013 (actual)
- Primary completion
- Jul 2014 (actual)
- Study completion
- 3 Nov 2015 (actual)
- First posted
- 24 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 90 Days
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)
9 secondary outcomes
Sensitivity of the ELISA test on urine and blood specimens
Time frame: At the time of inclusion (baseline)
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 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 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
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
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 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mathieu NACHER, MD, PhD study chair
CIE 802 Inserm / DGOS
Stephen G VREDEN, MD, PhD study chair
Foundation for Scientific Research Suriname (SWOS)
7 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV, run by ANRS, Emerging Infectious Diseases at 7 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in France, Suriname. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2024.