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 CancidasÂ® lyophilized for solution for infusion 50 mg and 70 mg manufactured by Merck Sharp & Dohme BV., Netherlands in patients with invasive candidiasis.

JSC Pharmasyntez Russia0 个研究点目标入组 244 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•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 38Â°Ð¡ or having other signs of generalized inflammation response.
•4 In case of acute disseminated candidiasis â??candidemia in combination with Candida spp. detected through histological examination and/or inoculation of samples obtained from deep tissues of two or more locations.

•1 Pregnant or breast feeding patients.
•2 Patients with hepatic diseases with Child-Pugh score exceeding 9.
•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.
•6 Patients with neutropenia (neutrophil count <=1000/Î¼l).
•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

发起方

JSC Pharmasyntez Russia