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 @ 2:32 AM
Ignite Modification Date:
2025-12-25 @ 2:32 AM
NCT ID:
NCT02908334
Eligibility Criteria:
Inclusion Criteria:
* Severe coccidioidomycosis infection, manifest as by one of:
* Coccidioidal meningitis;
* Severe pulmonary infection requiring intensive care unit level of care;
* Disseminated infection (in clinical opinion of the investigator); or
* Clinical progression after \>2 months of high dose fluconazole.
* Laboratory confirmation of Coccidioides infection by culture, histopathology, coccidioides polymerase chain reaction, positive complement fixation titer, or Coccidioides antigen
Exclusion Criteria:
* Age \< 18 years
* Cannot or unlikely to attend regular clinic visits
* Presence of jaundice or known liver cirrhosis
* Pregnancy
* If there is a concern of pregnancy, a negative urine (or serum) pregnancy test before study entry is required.
* Women of childbearing potential will have pregnancy test at enrollment and will be recommended to use contraception and referred to family planning services as necessary. (Refer to informed consent document.)
* Currently breastfeeding
* Active drug use (amphetamine or cocaine) or requirement for concomitant medications that raise the risk of serotonin syndrome
* Prolonged corrected QT interval or Left Bundle Branch Block on baseline electrocardiogram
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02908334
Study Brief:
Protocol Section:
NCT02908334