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.

ANRS, Emerging Infectious Diseases0 个研究点目标入组 727 人开始时间: 2013年8月最近更新: 2017年7月11日

适应症

试验速览

阶段: 不适用
发起方: ANRS, Emerging Infectious Diseases
入组人数: 727
主要终点: 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.

研究概览研究设计入排标准结局指标研究者记录与标识符相似试验

研究概览

简要总结

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.

研究设计

研究类型: Observational
观察模型: Other
时间视角: Cross Sectional

入排标准

年龄范围: 18 Years 至 —（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•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.

排除标准

•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.

结局指标

主要结局

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.

时间窗: At the time of inclusion (baseline)

次要结局

Sensitivity of the ELISA test on urine and blood specimens(At the time of inclusion (baseline))
Negative predictive value of the ELISA test on urine and blood specimens(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(At the time of inclusion (baseline))
Sensibility of the ELISA test on urine and blood specimens(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(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(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(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(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(30 days and 90 days after inclusion)

研究者

发起方

ANRS, Emerging Infectious Diseases

申办方类型

Other Gov

责任方

Sponsor

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