Sertraline in Addition to Standard of Care Treatment for Coccidioidomycosis

NCT ID: NCT02908334

Last Updated: 2022-03-21

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-11-30
• Study Completion Date: 2019-01-22

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.

Conditions

Coccidioidomycosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Standard of Care

standard of care treatment for disseminated or meningeal coccidioidomycosis

Group Type: NO_INTERVENTION

No interventions assigned to this group

Standard of Care + Sertraline

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

Group Type: EXPERIMENTAL

Sertraline

Intervention Type: DRUG

400 mg/day sertraline

Interventions

Sertraline

400 mg/day sertraline

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Simon Paul, MD

Role: PRINCIPAL_INVESTIGATOR

UCSF - Fresno

Other Identifiers

UCSF-Fresno-01

Identifier Type: -

Identifier Source: org_study_id