Sertraline in Addition to Standard of Care Treatment for Coccidioidomycosis

Coccidioidomycosis Clinical Trial

Official title:

Sertraline in Addition to Standard of Care Treatment for Coccidioidomycosis

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02908334
• Other study ID #: UCSF-Fresno-01
• Status: Withdrawn
• Phase: Phase 2
• Start date: November 2016
• Est. completion date: January 22, 2019

Study information

• Verified date: March 2022
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 22, 2019
• Est. primary completion date: January 22, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coccidioidomycosis

Intervention

Drug:
• Sertraline
400 mg/day sertraline

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse Reactions	grade 4-5 adverse reactions	2 years
Secondary	Mycoses Study Group Score	scoring of clinical outcomes	2 years
Secondary	Depression Screening	Patient Health Questionnaire 9	2 years
Secondary	Functional Assessment	Karnofsky	2 years