Sertraline in Addition to Standard of Care Treatment for Coccidioidomycosis

• Status: Withdrawn
• Trial end date: 2019-01-22
• Target enrollment: 0
• Participant gender: All

Summary

In this study patients will be randomized 1:2 to receive either standard of care treatment or standard of care + Sertraline 200mg/day for 2 weeks, then 400 mg/day for 50 weeks for treatment of disseminated and meningeal coccidioidomycosis.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of California, San Francisco
• Treatments: Sertraline

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