Efficacy and Safety of the Drug Product Caspofungi

Not Applicable

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

• Registration Number: CTRI/2017/04/008362
• Lead Sponsor: JSC Pharmasyntez Russia

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 244

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

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/μl).

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1 Clinical response rate in patients with invasive candidiasis, including candidaemia and acute disseminated candidiasis, in each treatment group. <br/ ><br>2 Bacterial efficacy rate <br/ ><br>Timepoint: at the end of the therapy

Secondary Outcome Measures

Name	Time	Method
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.