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Efficacy and Safety of the Drug Product Caspofungin

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.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2017/04/008362
Enrollment
244
Registered
2017-04-17
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- In patients with invasive candidiasis.

Interventions

Intervention1: Name of the test drug: Caspofungin : Manufacturer: Camus Pharma Pvt. Ltd., India Dosage Form: lyophilized for solution for infusion Description: White to off-white lyophilized solution

Sponsors

JSC Pharmasyntez Russia
Lead Sponsor
Nexus Clinical Research India Ltd
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: 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 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.

Exclusion criteria

Exclusion criteria: 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 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

Design outcomes

Primary

MeasureTime frame
1 Clinical response rate in patients with invasive candidiasis, including candidaemia and acute disseminated candidiasis, in each treatment group. 2 Bacterial efficacy rate Timepoint: at the end of the therapy—

Secondary

MeasureTime frame
Duration of stay of the compared groupsâ?? patients in the hospital.Timepoint: At the end of the therapy;Relapse rateTimepoint: At the follow-up visit.—

Countries

India, Russian Federation

Contacts

Public ContactDr Mangesh khadakban

Nexus Clinical Research (India) Ltd.

mangesh.khadakban@nexuscro.com9167243914

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026