Sertraline in Addition to Standard of Care Treatment for Coccidioidomycosis

University of California San Francisco (UCSF)

Status and phase: Withdrawn; Phase 2

Conditions: Coccidioidomycosis

Treatments: Drug: Sertraline

Study type: Interventional

Funder types: Other

Identifiers

NCT02908334

UCSF-Fresno-01

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Standard of Care

No Intervention group

Description:

standard of care treatment for disseminated or meningeal coccidioidomycosis

Standard of Care + Sertraline

Experimental group

Description:

Standard of care treatment with the addition of sertraline for the treatment of disseminated or meningeal coccidioidomycosis

Treatment:

Drug: Sertraline