Sertraline in Addition to Standard of Care Treatment for Coccidioidomycosis
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 主要终点
- Adverse Reactions
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Standard of Care + Sertraline
Standard of care treatment with the addition of sertraline for the treatment of disseminated or meningeal coccidioidomycosis
干预措施: Sertraline (Drug)
结局指标
主要结局
Adverse Reactions
时间窗: 2 years
grade 4-5 adverse reactions
次要结局
- Depression Screening(2 years)
- Mycoses Study Group Score(2 years)
- Functional Assessment(2 years)