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Trial record 14 of 331 for:    SERTRALINE

Sertraline in Addition to Standard of Care Treatment for Coccidioidomycosis

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ClinicalTrials.gov Identifier: NCT02908334
Recruitment Status : Not yet recruiting
First Posted : September 20, 2016
Last Update Posted : June 12, 2018
Sponsor:
Information provided by (Responsible Party):
Simon Paul, University of California, San Francisco

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.

Condition or disease Intervention/treatment Phase
Coccidioidomycosis Drug: Sertraline Phase 2

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Sertraline in Addition to Standard of Care Treatment for Coccidioidomycosis
Study Start Date : November 2016
Estimated Primary Completion Date : November 2020
Estimated Study Completion Date : November 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Valley Fever

Arm Intervention/treatment
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
400 mg/day sertraline




Primary Outcome Measures :
  1. Adverse Reactions [ Time Frame: 2 years ]
    grade 4-5 adverse reactions


Secondary Outcome Measures :
  1. Mycoses Study Group Score [ Time Frame: 2 years ]
    scoring of clinical outcomes

  2. Depression Screening [ Time Frame: 2 years ]
    Patient Health Questionnaire 9

  3. Functional Assessment [ Time Frame: 2 years ]
    Karnofsky



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02908334


Contacts
Contact: Simon Paul, MD 559 435 3709 spaul@fresno.ucsf.edu

Sponsors and Collaborators
University of California, San Francisco
Investigators
Principal Investigator: Simon Paul, MD UCSF - Fresno

Responsible Party: Simon Paul, Professor of Clinical Medicine, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT02908334     History of Changes
Other Study ID Numbers: UCSF-Fresno-01
First Posted: September 20, 2016    Key Record Dates
Last Update Posted: June 12, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Sertraline
Coccidioidomycosis
Coccidiosis
Mycoses
Protozoan Infections
Parasitic Diseases
Antidepressive Agents
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs