A prospective, observational, open label study to evaluate efficacy and safety of Anidulafungin in comparison to Caspofungin in Invasive Candida infections in India (ADVANCE)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 180
- 试验地点
- 5
- 主要终点
- To evaluate and compare the efficacy and safety of Anidulafungin and Caspofungin in Invasive Candida infections in ICUs.
研究概览
简要总结
This is a prospective, observational,multicenter, open label study to evaluate and compare the safety and efficacyof 180 adult patients with Invasive Candida infection at 5-7 sites acrossIndia. Prior to being enrolled into the study patients must provide a writtenauthorization to the investigator to use or disclose personal and/or clinicaldata and meet the study eligibility criteria.
The data points to beconsidered in the study shall include demography, anthropometry, vital signs,body temperature, medical history, prior medications, risk factors for candida,candida scores, microbiology testing, laboratory assessments, concomitantmedication, clinical evaluation including APACHE II scores and microbiologicalevaluation, any treatment emergent adverse events, treatment given and anychange in dose or treatment during the hospitalization period
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients of either sex with age ≥18 years with a confirmed cases of Invasive Candida infection.
- •Patients who will be able to provide the informed consent.
- •Patients prescribed with Caspofungin or Anidulafungin.
排除标准
- •Patients of either sex with age less than 18 years.
- •Patients with aspergillus or any other mold or yeast [Cryptococcus] infections.
- •Patients on Micafungin or other antifungal agents.
- •Pregnant or breast-feeding women.
结局指标
主要结局
To evaluate and compare the efficacy and safety of Anidulafungin and Caspofungin in Invasive Candida infections in ICUs.
时间窗: Day 1 to Day 14
次要结局
- To determine the distribution pattern of co-morbidities and risk factors for Invasive Candida infection(Day 1 to Day 14)
- To determine the duration of treatment, number of hospital days and mortality of patients with Invasive Candida Infection.(Day 1 to Day 14)
- To assess the clinical signs and symptoms, baseline candida pathogen, candida scores(Day 1 to Day 14)
- To assess liver and renal functioning.(Day 1 to Day 14)