A Multicenter, Double-Blind, Randomized, Comparator-Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of Caspofungin Versus Amphotericin B Deoxycholate in the Treatment of Invasive Candidiasis in Neonates and Infants Less Than 3 Months of Age
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 51
- 主要终点
- Percentage of Participants With Fungal-free Survival Through the 2-week Post-therapy Period
研究概览
简要总结
The study will evaluate the safety, tolerability, and efficacy of caspofungin as compared with amphotericin B deoxycholate in the treatment of invasive candidiasis in neonates and infants. The primary hypothesis to be tested in the study is that caspofungin will be superior to amphotericin B deoxycholate with regard to the proportion of participants with fungal-free survival at the 2-week post-therapy follow-up visit.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- — 至 3 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Culture-confirmed invasive Candida infection
排除标准
- •Candida disease limited to the oropharynx, esophagus, or other mucosal or superficial skin surfaces
- •Positive culture for Candida only from sputum, broncho-alveolar lavage, catheter tip, or previously placed indwelling non-vascular catheters or drains
- •Prosthetic device as the suspected site of Candida infection
- •Active co-infection with a non-Candida fungal organism
- •Received >48 hours of systemic antifungal treatment since the positive Candida index culture was collected as therapy for the present episode of invasive candidiasis
- •Failed prior systemic antifungal therapy for the present episode of invasive candidiasis
- •Diagnosis of acute hepatitis or cirrhosis
- •Scheduled or anticipated to receive rifampin or other systemic antifungal therapy while on study therapy
- •History (including participant's mother) of allergy, hypersensitivity, or any serious reaction to caspofungin or other member of the echinocandin class, or to amphotericin B deoxycholate or other member of the polyene class
- •Severe congenital disorder known to lower immune response
研究组 & 干预措施
Caspofungin
Caspofungin 2 mg/kg intravenous once daily for ≥14 days after documented negative culture and improvement of clinical signs and symptoms, for a maximum of 90 days treatment
干预措施: Caspofungin (Drug)
Amphotericin B Deoxycholate
Amphotericin B deoxycholate 1 mg/kg intravenous once daily for ≥14 days after documented negative culture and improvement of clinical signs and symptoms, for a maximum of 90 days treatment
干预措施: Amphotericin B Deoxycholate (Drug)
结局指标
主要结局
Percentage of Participants With Fungal-free Survival Through the 2-week Post-therapy Period
时间窗: Up to 104 days
Fungal-free survival is those participants who survived up to 2 weeks post-therapy, and had documented microbiological eradication of Candida species (sp.) from follow-up cultures collected after the initiation of study therapy. Microbiological eradication denotes negative follow-up cultures for Candida sp. from the site of infection. If a culture is not obtained on the day of assessment, the last culture after study entry may be used to assist in the assessment of microbiological eradication. If the last culture is negative for Candida sp., then microbiological eradication would be considered achieved.
次要结局
- Percentage of Participants With Fungal-free Survival Through the End of Study Treatment(Up to 90 days)
- Number of Participants With an Adverse Event (AE)(8 weeks after end of study therapy (up to 146 days))