Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:58 PM
Ignite Modification Date:
2025-12-24 @ 9:58 PM
NCT ID:
NCT05814432
Eligibility Criteria:
Inclusion Criteria:
* Adult patients admitted to the centers that will be part of the study
* Infected by the HIV, regardless of the use of antiretroviral therapy
* Patients diagnosed with disseminated histoplasmosis, confirmed by classical mycological methods (microscopy, culture or histopathology) or urinary Histoplasma antigen detection
* Patients with central nervous system (CNS) infection may be included if they have an alternative diagnosis suggestive of another CNS infection
* Patients using fluconazole for oroesophageal candidiasis may be included
Exclusion criteria:
* Refusal to participate in the trial
* Previous diagnosis of histoplasmosis
* Pregnant or lactating women
* Patients with renal failure at any given time (serum creatinine \> 2x or upper limit of normality (KDIGO, 2012)
* Previous severe reaction to a polyene antifungal
* Receipt of more than one dose of a polyene antifungal in the last 48 h
* Suspected histoplasmosis involving the central nervous system
* Patients who, in the judgment of the attending physician, have the prospect of death within the next 48 hours after selection, will also be excluded
* Patients with suspected histoplasmosis involving the central nervous system (CNS), as this condition requires high doses of amphotericin B
* Patients with the prospect of death in the next 48 hours after selection
* Patients with a concomitant diagnosis of cryptococcus will be excluded, as will patients with leishmaniasis in treatment or in secondary prophylaxis with amphotericin
* Patients without the capacity to administer enteral medication-at the discretion of the principal investigator of each center-considering that these patients will not be able to use itraconazole orally or through a feeding tube
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05814432
Study Brief:
Protocol Section:
NCT05814432