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 @ 5:00 PM
Ignite Modification Date:
2025-12-24 @ 5:00 PM
NCT ID:
NCT07261150
Eligibility Criteria:
Inclusion Criteria:
* Age ≥18 years
* Hospitalized with suspected histoplasmosis b
* Diagnosis of confirmed or probable histoplasmosis (via positive Histoplasma antigen test, culture, histopathology or microscopy)
* Provision of Informed Consent by participant or surrogate c
Exclusion Criteria:
* Previous diagnosis of histoplasmosis
* Pregnant persons (all persons who could potentially be pregnant will have a pregnancy test prior to enrollment, and if negative, must agree to contraception for the duration of the study)
* Breastfeeding and unable to stop for the duration of the study
* Renal impairment (serum creatinine or blood urea nitrogen (BUN) \>2.0x upper limit of normal)
* Allergy or contraindication to a study medicine
* More than one dose of an amphotericin product in the prior 7 days
* Suspected central nervous system involvement of histoplasmosis
* Likely to die in the next 48 hours in the judgment of the investigator
* Unlikely to follow up for the duration of the study in the judgement of the investigator
* Significant drug-drug interaction with itraconazole or posaconazole (such as rifampin in persons with TB)
* Current diagnosis of cryptococcosis or leishmaniasis
* QTc interval consistently \>450 milliseconds
* Prisoners
* Unable to take oral medications
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07261150
Study Brief:
Protocol Section:
NCT07261150