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Trial record 1 of 1 for:    COCCIDIOIDOMYCOSIS SERTRALINE
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Sertraline in Addition to Standard of Care Treatment for Coccidioidomycosis

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ClinicalTrials.gov Identifier: NCT02908334
Recruitment Status : Withdrawn (failure to enroll)
First Posted : September 20, 2016
Last Update Posted : April 4, 2019
Sponsor:
Information provided by (Responsible Party):
Simon Paul, University of California, San Francisco

Tracking Information
First Submitted Date  ICMJE September 14, 2016
First Posted Date  ICMJE September 20, 2016
Last Update Posted Date April 4, 2019
Study Start Date  ICMJE November 2016
Actual Primary Completion Date January 22, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 16, 2016)
Adverse Reactions [ Time Frame: 2 years ]
grade 4-5 adverse reactions
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 16, 2016)
  • Mycoses Study Group Score [ Time Frame: 2 years ]
    scoring of clinical outcomes
  • Depression Screening [ Time Frame: 2 years ]
    Patient Health Questionnaire 9
  • Functional Assessment [ Time Frame: 2 years ]
    Karnofsky
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Sertraline in Addition to Standard of Care Treatment for Coccidioidomycosis
Official Title  ICMJE Sertraline in Addition to Standard of Care Treatment for Coccidioidomycosis
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Coccidioidomycosis
Intervention  ICMJE Drug: Sertraline
400 mg/day sertraline
Study Arms  ICMJE
  • 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
    Intervention: Drug: Sertraline
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: April 2, 2019)
0
Original Estimated Enrollment  ICMJE
 (submitted: September 16, 2016)
120
Actual Study Completion Date  ICMJE January 22, 2019
Actual Primary Completion Date January 22, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02908334
Other Study ID Numbers  ICMJE UCSF-Fresno-01
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Simon Paul, University of California, San Francisco
Study Sponsor  ICMJE University of California, San Francisco
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Simon Paul, MD UCSF - Fresno
PRS Account University of California, San Francisco
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP