Coccidioidomycosis
Conditions
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.
Interventions
DRUGSertraline
400 mg/day sertraline
Sponsors
University of California, San Francisco
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Reactions | 2 years | grade 4-5 adverse reactions |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mycoses Study Group Score | 2 years | scoring of clinical outcomes |
| Depression Screening | 2 years | Patient Health Questionnaire 9 |
| Functional Assessment | 2 years | Karnofsky |
Outcome results
None listed