Sertraline in Addition to Standard of Care Treatment for Coccidioidomycosis
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2 |
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| No Intervention: Standard of Care standard of care treatment for disseminated or meningeal coccidioidomycosis |
|
| Experimental: Standard of Care + Sertraline Standard of care treatment with the addition of sertraline for the treatment of disseminated or meningeal coccidioidomycosis |
Drug: Sertraline
400 mg/day sertraline
|
Outcome Measures
Primary Outcome Measures
- Adverse Reactions [2 years]
grade 4-5 adverse reactions
Secondary Outcome Measures
- Mycoses Study Group Score [2 years]
scoring of clinical outcomes
- Depression Screening [2 years]
Patient Health Questionnaire 9
- Functional Assessment [2 years]
Karnofsky
Eligibility Criteria
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
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- University of California, San Francisco
Investigators
- Principal Investigator: Simon Paul, MD, UCSF - Fresno
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- UCSF-Fresno-01