CClinicalTrials.gg
WithdrawnNCT02908334Updated Mar 21, 2022

Sertraline in Addition to Standard of Care Treatment for Coccidioidomycosis

A Phase 2 interventional study of Sertraline in Coccidioidomycosis, sponsored by University of California, San Francisco. Withdrawn. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-03-21.

Sponsored by University of California, San Francisco · Phase 2, Interventional, and Treatment

Why this study was withdrawn
failure to enroll
Phase
Phase 2
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Coccidioidomycosis
03

In context

Coccidioidomycosis

25 studies on the registry are indexed under Coccidioidomycosis; 5 are open to participants now.

Browse Coccidioidomycosis studies →

Lead sponsor

University of California, San Francisco is the lead sponsor of 2,132 studies on the registry; 375 are open to participants now.

Of its 262 completed or terminated interventional studies of FDA-regulated products, 196 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts 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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • 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

Interventions

  • DrugSertraline

    400 mg/day sertraline

06

What researchers measure

Primary outcomes

  1. Adverse Reactions

    grade 4-5 adverse reactions

    Time frame: 2 years

Secondary outcomes

  1. Mycoses Study Group Score

    scoring of clinical outcomes

    Time frame: 2 years

  2. Depression Screening

    Patient Health Questionnaire 9

    Time frame: 2 years

  3. Functional Assessment

    Karnofsky

    Time frame: 2 years

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 21, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02908334
Lead sponsor
University of California, San Francisco
Responsible party
Sponsor
First posted
Sep 20, 2016
Start date
Nov 2016
Primary completion
Jan 22, 2019
Completion
Jan 22, 2019
Last update
Mar 21, 2022

Study contacts

Simon Paul, MD
principal investigator · UCSF - Fresno

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion