EUCTR2009-014600-66-NL进行中（未招募）1 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
niversity Medical Center Nijmegen0 个研究点开始时间: 2010年5月24日最近更新:
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试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
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 old 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 determination 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 canidiasis
- •Subject or their legal representative must sign a written informed consent form.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Subjects with a history of allergy or intolerance to echinocandines or IFNgamma
- •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.
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