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:
2025-12-25 @ 3:07 AM
Ignite Modification Date:
2025-12-25 @ 3:07 AM
NCT ID:
NCT04031833
Eligibility Criteria:
Inclusion Criteria:
* Phase 1:
* Age \>18 years
* Calculated creatinine clearance \>70 mL/min/1.73 m2 (measured within 3 months)
* Written informed consent
Phase 2:
* Cryptococcal meningitis diagnosed by CSF cryptococcal antigen (CRAG)
* Ability and willingness to provide informed consent
* Willing to receive protocol-specified lumbar punctures
Exclusion Criteria:
* Phase 1:
* Symptomatic Current illness
* Known significant, untreated health problem
* Inability to take enteral medicine
* Pregnant or breast feeding
* Receiving amphotericin B therapy in past 90 days
* Phase 2:
* Presenting Glasgow Coma Scale (GCS) \< 15
* Received 3 or more doses of IV amphotericin therapy within last 30 days
* Inability to take enteral (oral or nasogastric) medicine
* Cannot or unlikely to attend regular clinic visits
* Pregnancy or breastfeeding
* Receiving chemotherapy or corticosteroids
* Suspected Paradoxical immune reconstitution inflammatory syndrome (IRIS)
* Recent initiation of HIV therapy or ART class switch (within 2 weeks)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04031833
Study Brief:
Protocol Section:
NCT04031833