International, multicentre, randomized, open-label, comparative clinical study of efficacy and safety of the drug product Caspofungin lyophilized for solution for infusion 50 mg and 70 mg manufactured by Camus Pharma Pvt. Ltd., India and the drug product Cancidas® lyophilized for solution for infusion 50 mg and 70 mg manufactured by Merck Sharp & Dohme BV., Netherlands in patients with invasive candidiasis.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 244
- 试验地点
- 1
- 主要终点
- 1 Clinical response rate in patients with invasive candidiasis, including candidaemia and acute disseminated candidiasis, in each treatment group.
研究概览
简要总结
It is a prospective, randomized, multicentre, open-label, comparative study. After having signed the Informed consent the successfully screened patients with clinical signs and symptoms of invasive candidiasis and without neutropenia, meeting all the inclusion and none of exclusion criteria, will be included in the study. Patients are proposed to be in the hospital for at least 28 days. A patient diagnosed with clinical and microbiological recovery will be discharged from the hospital and switched to out-patient treatment.
The study will be initiated from evaluation of inclusion/exclusion criteria in the course of screening visit. Patients meeting all the inclusion criteria at moment of the randomisation visit will be randomised in one of the study groups at a ratio of 1:1 to receive either the test drug Caspofungin (70 mg at day 1 followed by 50 mg) once a day intravenously or the reference drug Cancidas® (70 mg at day 1 followed by 50 mg) once a day intravenously.
Caspofungin maintenance dose will be adjusted to 35 mg for the patients with moderate hepatic impairment, diagnosed according to Child-Pugh score in the range of 7 to 9. Dosage adjustment will not be required for the patients with renal impairment.
TD/RD extent of exposure will be individual for each of patients and will be at least 14 days after the negative culture-based test in blood or infection site are obtained and clinical signs of invasive candidiasis are stopped. 28 ± 2 days after TD/RD treatment termination, relapse rate and safety parameters will be assessed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1 Patients that are capable and willing to comply with protocol and voluntarily signed the Informed Consent Form prior any study procedure; 2 Patients with invasive candidiasis including candidemia and acute disseminated candidiasis, and confirmed positive result of the following examinations detection of fungi of Candida species through histological examination, cytological examination or direct microscopy of a sample obtained through exploratory puncture or biopsy sampling from normally sterile bio-substrate within the period of the last 4 days.
- •3 positive result of triple inoculations (within 24 hours) of peripheral blood samples to detect Candida spp., obtained in patients with body temperature exceeding 38°С or having other signs of generalized inflammation response.
- •4 In case of acute disseminated candidiasis –candidemia in combination with Candida spp.
- •detected through histological examination and/or inoculation of samples obtained from deep tissues of two or more locations.
排除标准
- •1 Pregnant or breast feeding patients.
- •2 Patients with hepatic diseases with Child-Pugh score exceeding
- •3 Patients with life expectancy less than half a year.
- •4 Patients diagnosed with or suspected of Candida endocarditis, osteomyelitis or meningitis.
- •5 Combined fungemia.
- •7 Patients underwent organ transplantation.
- •8 Hindered vein access complicating intravenous administration of the drug.
- •9 Concomitant treatment with cyclosporine.
- •10 Echinocandin treatment within period of 1-month prior randomizatio.
结局指标
主要结局
1 Clinical response rate in patients with invasive candidiasis, including candidaemia and acute disseminated candidiasis, in each treatment group.
时间窗: at the end of the therapy
2 Bacterial efficacy rate
时间窗: at the end of the therapy
次要结局
- Duration of stay of the compared groups’ patients in the hospital.(At the end of the therapy)
- Relapse rate(At the follow-up visit.)