Sertraline in Addition to Standard of Care Treatment for Coccidioidomycosis

Phase 2

Withdrawn

• Conditions: Coccidioidomycosis
• Interventions: Drug: Sertraline

• Registration Number: NCT02908334
• Lead Sponsor: University of California, San Francisco

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 Description

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.

Study Timeline

• Study First Submitted: 2016-09-14
• Study First Submitted QC: 2016-09-16
• Study First Posted: 2016-09-20
• Study Start: 2016-11
• Primary Completion: 2019-01-22
• Study Completion: 2019-01-22
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-07
• Last Update Posted: 2022-03-21

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Standard of Care + Sertraline	Sertraline	Standard of care treatment with the addition of sertraline for the treatment of disseminated or meningeal coccidioidomycosis

Primary Outcome Measures

Name	Time	Method
Adverse Reactions	2 years	grade 4-5 adverse reactions

Secondary Outcome Measures

Name	Time	Method
Depression Screening	2 years	Patient Health Questionnaire 9
Functional Assessment	2 years	Karnofsky
Mycoses Study Group Score	2 years	scoring of clinical outcomes