CoccidioidomycosisPhase 2NCT02908334
Sertraline in Addition to Standard of Care Treatment for Coccidioidomycosis
A Phase 2 study testing Sertraline in people with Coccidioidomycosis, run by University of California, San Francisco.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coccidioidomycosis
- What is being tested?
- Sertraline
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Nov 2016to 22 Jan 2019
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.)
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- 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
About this study
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.
- Conditions
- Coccidioidomycosis
- Being tested
- Sertraline
- Medical subject headings
- Coccidioidomycosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SertralineDrug
400 mg/day sertraline
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Sertraline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Reactions
grade 4-5 adverse reactions
Measured: 2 years
Secondary outcomes (3)
Mycoses Study Group Score
scoring of clinical outcomes
Measured: 2 years
Depression Screening
Patient Health Questionnaire 9
Measured: 2 years
Functional Assessment
Karnofsky
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2016 (estimated)
- Study startNov 2016
- Primary completion22 Jan 2019
- Study completion22 Jan 2019
Why it stopped: failure to enroll
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CoccidioidomycosisStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Simon Paul, MD, Principal investigator, UCSF - Fresno
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02908334
- Sponsor's protocol ID
- UCSF-Fresno-01
- Status last verified
- Mar 2022
- First submitted
- 14 Sep 2016
- Last updated
- 21 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sertraline in Addition to Standard of Care Treatment for Coccidioidomycosis
- ClinicalTrials.gov ID
- NCT02908334
- Acronym / sponsor ID
- UCSF-Fresno-01
- Conditions
- Coccidioidomycosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: failure to enroll
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- Nov 2016
- Primary completion
- 22 Jan 2019 (actual)
- Study completion
- 22 Jan 2019 (actual)
- First posted
- 20 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | No intervention | –standard of care treatment for disseminated or meningeal coccidioidomycosis |
| Standard of Care + Sertraline | Experimental | Drug: SertralineStandard of care treatment with the addition of sertraline for the treatment of disseminated or meningeal coccidioidomycosis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Severe coccidioidomycosis infection, manifest as by one of:
- Laboratory confirmation of Coccidioides infection by culture, histopathology, coccidioides polymerase chain reaction, positive complement fixation titer, or Coccidioides antigen
Key exclusion criteria (9 listed)
- Age < 18 years
- Cannot or unlikely to attend regular clinic visits
- Presence of jaundice or known liver cirrhosis
- Pregnancy
- Currently breastfeeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sertraline400 mg/day sertraline | Drug | Standard of Care + Sertraline |
Primary outcome
Adverse Reactions
Time frame: 2 years
grade 4-5 adverse reactions
3 secondary outcomes
Mycoses Study Group Score
Time frame: 2 years
Depression Screening
Time frame: 2 years
Functional Assessment
Time frame: 2 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Simon Paul, MD principal investigator
UCSF - Fresno
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sertraline in people with Coccidioidomycosis, run by University of California, San Francisco.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 21 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Reactions (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2022.