NCT02895529终止4 期
A Multicenter, Randomized Trial Comparing The Efficacy of Intravenous Followed by Oral Itraconazole With Intravenous Caspofungin For Empiric Antifungal Therapy in Neutropenic Subjects With Hematological Malignancy
Xian-Janssen Pharmaceutical Ltd.0 个研究点目标入组 61 人开始时间: 2016年11月30日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 61
- 主要终点
- Response Rate Measured by the Percentage of Participants That Achieve all of the Following 5 Composite Endpoints
研究概览
简要总结
The purpose of this study is to investigate the hypothesis that the efficacy of intravenous (IV) itraconazole followed by oral itraconazole is non-inferior to that of intravenous caspofungin as empiric therapy for suspected fungal infection participants with fever and neutropenia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Participant must be hospitalized with hematologic malignancy treated by myelosuppressive therapy and/or Hematopoietic stem cell transplantation
- •Participant must have a diagnosis of neutropenia with neutrophil count < 500/microliters (mcL) (0.5 × 10^9/ liters [L]) for at least 96 hours at screening
- •Participant must have a diagnosis of fever and meet the following criteria: 1) Oral/rectal temperature greater than or equal to (>=) 38 degree celsius or axillary temperature (>=) 37.5 degree celsius and is not considered related to blood products transfusion or drug fever, 2) Not responding to broad-spectrum gram-positive and gram-negative antibiotics for 4-7 days with or without signs and symptoms that potentially attributable to deep fungal infection and 3) Defervescence within 3 days after the first broad-spectrum antibiotics but recurrence afterwards.
- •A woman of childbearing potential must have a negative serum (beta human chorionic gonadotropin [b hCG]) and pregnancy test at screening
- •A woman must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study period and until the menstrual period following the end of study treatment
排除标准
- •Is concomitantly using other systematic antifungal drugs as empirical treatment
- •Has evidence of inadequately managed bacterial infection
- •Is currently receiving any Cytochrome P450 3A4 (CYP3A4)-metabolized/P-glycoprotein-transported drugs (including but not limited to cisapride, pimozide, quinidine, dofetilide, levacetylmethadol, terfenadine, astemizole, mizolastine, bepridil, sertindole, 3-hydroxy-3-methyl-glutaryl-coenzyme A reductase (HMG-CoA reductase) inhibitor [for example, simvastatin, lovastatin], oral midazolam, triazolam, ergot alkaloids [eg, dihydroergotamine, ergonovine, ergotamine, methylergonovine] and nisoldipine) that should be prohibited in this study
- •Has known allergy, intolerance or hypersensitivity to azole and echinocandin antifungals or its excipients
- •Has a contraindication to the use of sodium chloride injection
研究组 & 干预措施
Itraconazole
Experimental
干预措施: Itraconazole (Drug)
Caspofungin
Active Comparator
干预措施: Caspofungin (Drug)
结局指标
主要结局
Response Rate Measured by the Percentage of Participants That Achieve all of the Following 5 Composite Endpoints
时间窗: Up to 36 days
Response rate in each of the 2 treatment groups will be measured by the percentage of participants that achieve all of the following 5 composite endpoints: 1) survival for 7 days after completion of treatment, 2) absence of breakthrough invasive fungal infection during the study drug administration and within the first 7 days after completion of treatment, 3) successful treatment of baseline fungal infection, 4) defervescence and 5) no premature withdrawal from the study due to drug-related toxicity or lack of efficacy.
次要结局
- Percentage of Participants With Survival for 7 Days After Completion of Treatment(Up to 36 days)
- Percentage of Participants With Absence of Breakthrough Invasive Fungal Infection(Day 3 up to Day 28 (End of treatment [EoT]) and within 7 days after EoT (Day 29 up to Day 35))
- Percentage of Participants With Successful Treatment of Baseline Fungal Infection(Screening up to Day 3)
- Percentage of Participants With Defervescence During the Period of Neutropenia(Up to 36 days)
- Percentage of Participants With No Premature Withdrawal From the Study due to Drug-related Toxicity or Lack of Efficacy(Up to 36 days)
- Response Rate Measured by the Percentage of Participants That Achieve all of the Following 5 Composite Endpoints With Oral Administration of Itraconazole(Up to 36 days)
研究者
相似试验
已完成
3 期
Safety, Efficacy, and Pharmacokinetic Study of Intravenous Ibuprofen in Pediatric PatientsFeverNCT01002573Cumberland Pharmaceuticals118
已完成
3 期
Anifrolumab Asian PhIII Efficacy Study for Systemic Lupus Erythematosus (SLE)Active Systemic Lupus ErythematosusNCT04931563AstraZeneca277
已完成
3 期
Efficacy and Safety of Two Doses of Anifrolumab Compared to Placebo in Adult Subjects With Active Systemic Lupus ErythematosusActive Systemic Lupus ErythematosusNCT02446912AstraZeneca460
已完成
3 期
Efficacy and Safety of Anifrolumab Compared to Placebo in Adult Subjects With Active Systemic Lupus ErythematosusActive Systemic Lupus ErythematosusNCT02446899AstraZeneca373
已完成
2 期
Safety and Efficacy of Two Doses of Anifrolumab Compared to Placebo in Adult Subjects With Active Proliferative Lupus NephritisLupus NephritisNCT02547922AstraZeneca147