Sertraline in Addition to Standard of Care Treatment for Coccidioidomycosis

NCT02908334 | Withdrawn Phase 2

• 1 other identifier: UCSF-Fresno-01
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Coccidioidomycosis

Outcome Measures

Primary Outcomes (1)

• Adverse Reactions

  grade 4-5 adverse reactions

  2 years

Secondary Outcomes (3)

• Mycoses Study Group Score

  2 years

• Depression Screening

  2 years

• Functional Assessment

  2 years

Study Arms (2)

Standard of Care

NO INTERVENTION

standard of care treatment for disseminated or meningeal coccidioidomycosis

Standard of Care + Sertraline

EXPERIMENTAL

Standard of care treatment with the addition of sertraline for the treatment of disseminated or meningeal coccidioidomycosis

Drug: Sertraline

Interventions

Sertraline DRUG

400 mg/day sertraline

Standard of Care + Sertraline

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Francisco: lead

MeSH Terms

Conditions

Coccidioidomycosis

Interventions

Sertraline

Condition Hierarchy (Ancestors)

Mycoses; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

1-Naphthylamine; Amines; Organic Chemicals; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds

Study Officials

• Simon Paul, MD

  UCSF - Fresno

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2016
• First Posted: September 20, 2016
• Study Start: November 1, 2016
• Primary Completion: January 22, 2019
• Study Completion: January 22, 2019
• Last Updated: March 21, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share