Clinical Trial: Sertraline in Addition to Standard of Care Treatment for Coccidioidomycosis

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: Sertraline in Addition to Standard of Care Treatment for Coccidioidomycosis

Brief 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.

Detailed Summary: 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.
Sponsor: University of California, San Francisco

Current Primary Outcome: Adverse Reactions [ Time Frame: 2 years ]

grade 4-5 adverse reactions


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Mycoses Study Group Score [ Time Frame: 2 years ]
    scoring of clinical outcomes
  • Depression Screening [ Time Frame: 2 years ]
    Patient Health Questionnaire 9
  • Functional Assessment [ Time Frame: 2 years ]
    Karnofsky


Original Secondary Outcome: Same as current

Information By: University of California, San Francisco

Dates:
Date Received: September 14, 2016
Date Started: November 2016
Date Completion: November 2020
Last Updated: September 16, 2016
Last Verified: September 2016