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Eligibility
for people ages 18 years and up
Dates
study started
estimated completion:
Principal Investigator

Description

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.

Details

Sertraline has been demonstrated to have in-vitro activity against coccidioides, and in-vivo activity against cryptococcal meningitis in clinical trials. Disseminated and meningeal coccidiodes infections require lifelong treatment, have poor outcomes, and new treatment options are needed. In this study the investigators will determine safety and tolerability of adjunctive sertraline (grade 4-5 adverse reactions) compared to standard coccidioidomycosis therapy alone.

Keywords

Coccidioidomycosis Sertraline

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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

You CAN'T join if...

  • 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

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
ID
NCT02908334
Phase
Phase 2
Lead Scientist
Simon Paul
Study Type
Interventional
Last Updated
September 1, 2016
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