NL-OMON35641招募中3 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 - Efficacy of interferon in the treatment of candidemia
niversitair Medisch Centrum Sint Radboud0 个研究点目标入组 20 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
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 canidiasis
- •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 Interferon gamma
- •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.
研究者
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