NCT01270490Unknown3 期
A Multicentre, Prospective, Randomized Open-label Pilot Study to Assess the Feasibility and Preliminary Efficacy of Interferon-gamma in Combination With Anidulafungin for the Treatment of Candidemia
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- the time to negative blood cultures
研究概览
简要总结
The purpose of this study is to assess the feasibility and preliminary efficacy of interferon-gamma in combination with anidulafungin for the treatment of candidemia
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
- •Males or non-pregnant females (who must agree to use barrier methods of contraception during the study therapy period, women of childbearing age must have a negative urine pregnancy or serum test at baseline).
- •Subjects who are 18 years of age or older
- •Subjects with at least one positive blood culture isolation of Candida species from a specimen drawn within 96 hours prior to study entry.
- •Subjects who have clinical evidence of infection AT SOME TIME WITHIN 96 HOURS PRIOR TO ENROLLMENT, including AT LEAST ONE of the following:
- •Temperature >37.8 ˚C on 2 occasions at least 4 hours apart or one measurement > 38.2 ˚C
- •Systolic blood pressure <90 or a >30 mmHg decrease in systolic BP from the subject's normal baseline.
- •Signs of inflammation (swelling, heat, erythema, purulent drainage) from a site infected with Candida (eg, joint, skin, eye, bone, esophagus)
- •Radiologic findings of invasive candidiasis
- •Subject or their legal representative must sign a written informed consent form.
排除标准
- •Subjects with a history of allergy or intolerance to echinocandins or IFNgamma
- •Subjects with a history of documented epileptic seizures
- •Subjects with severe renal impairment (creatinine clearance less than 30/mL/min)
- •Subjects with severe liver failure (impaired synthesis of proteins such as coagulation factors manifested by increased prothrombin time)
- •Subjects with an absolute neutrophil count of less than 500/mm3 at study entry
- •Women who are pregnant or lactating
- •Subjects who are unlikely to survive more than 24 hours
- •Subjects who have failed previous systemic antifungal therapy for the Candida spp. infection which is being studied.
- •Subjects who have received more than 48 hours of systemic antifungal therapy for the current episode, within 96 hours prior to study entry
研究组 & 干预措施
Interferon-gamma
Experimental
干预措施: Interferon-gamma, Recombinant (Drug)
结局指标
主要结局
the time to negative blood cultures
时间窗: at fixed time points during follow up (at least until 8 weeks after end of treatment)
次要结局
- overall survival(until 8 weeks after end of treatment)
- time to death(Until 8 weeks after end of treatment)
- outcome of fungal infection(Until 8 weeks after end of treatment)
- duration of antifungal therapy(Until end of treatment)
- duration of hospitalization(Until end of hospitilization)
- immunological parameters(Until 8 weeks after end of treatment)
- tolerability and safety(until 8 weeks after end of treatment)
研究者
Corine Delsing
Drs
Radboud University Medical Center
研究点 (1)
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