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failure to enroll
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sertraline | Drug | 400 mg/day sertraline |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Reactions | grade 4-5 adverse reactions | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Mycoses Study Group Score | scoring of clinical outcomes | 2 years |
| Depression Screening | Patient Health Questionnaire 9 | 2 years |
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Inclusion Criteria:
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
Exclusion Criteria:
Age < 18 years
Cannot or unlikely to attend regular clinic visits
Presence of jaundice or known liver cirrhosis
Pregnancy
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
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| Name | Affiliation | Role |
|---|---|---|
| Simon Paul, MD | UCSF - Fresno | Principal Investigator |
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| ID | Term |
|---|---|
| D003047 | Coccidioidomycosis |
| ID | Term |
|---|---|
| D009181 | Mycoses |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D020280 | Sertraline |
| ID | Term |
|---|---|
| D015057 | 1-Naphthylamine |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D009281 | Naphthalenes |
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| Functional Assessment | Karnofsky | 2 years |
| D011084 |
| Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D011083 | Polycyclic Compounds |