Back to resultsSertraline in Addition to Standard of Care Treatment for Coccidioidomycosis
Primary Purpose
Coccidioidomycosis
Status
Withdrawn
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Sertraline
Sponsored by
About this trial
This is an interventional treatment trial for Coccidioidomycosis
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Standard of Care
Standard of Care + Sertraline
Arm Description
standard of care treatment for disseminated or meningeal coccidioidomycosis
Standard of care treatment with the addition of sertraline for the treatment of disseminated or meningeal coccidioidomycosis
Outcomes
Primary Outcome Measures
Adverse Reactions
grade 4-5 adverse reactions
Secondary Outcome Measures
Mycoses Study Group Score
scoring of clinical outcomes
Depression Screening
Patient Health Questionnaire 9
Functional Assessment
Karnofsky
Full Information
NCT ID
NCT02908334
First Posted
September 14, 2016
Last Updated
March 7, 2022
Sponsor
University of California, San Francisco
1. Study Identification
Unique Protocol Identification Number
NCT02908334
Brief Title
Sertraline in Addition to Standard of Care Treatment for Coccidioidomycosis
Official Title
Sertraline in Addition to Standard of Care Treatment for Coccidioidomycosis
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Withdrawn
Why Stopped
failure to enroll
Study Start Date
November 2016 (undefined)
Primary Completion Date
January 22, 2019 (Actual)
Study Completion Date
January 22, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coccidioidomycosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Standard of Care
Arm Type
No Intervention
Arm Description
standard of care treatment for disseminated or meningeal coccidioidomycosis
Arm Title
Standard of Care + Sertraline
Arm Type
Experimental
Arm Description
Standard of care treatment with the addition of sertraline for the treatment of disseminated or meningeal coccidioidomycosis
Intervention Type
Drug
Intervention Name(s)
Sertraline
Intervention Description
400 mg/day sertraline
Primary Outcome Measure Information:
Title
Adverse Reactions
Description
grade 4-5 adverse reactions
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Mycoses Study Group Score
Description
scoring of clinical outcomes
Time Frame
2 years
Title
Depression Screening
Description
Patient Health Questionnaire 9
Time Frame
2 years
Title
Functional Assessment
Description
Karnofsky
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Simon Paul, MD
Organizational Affiliation
UCSF - Fresno
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Sertraline in Addition to Standard of Care Treatment for Coccidioidomycosis
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