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A Multicenter, Randomized, Double-Blind, Comparative Study to Evaluate the Safety, Tolerability, and Efficacy of 2 Dosing Regimens of Caspofungin in the Treatment of Invasive Candidiasis in Adults. - MK-0991 High Dose Study

A Multicenter, Randomized, Double-Blind, Comparative Study to Evaluate the Safety, Tolerability, and Efficacy of 2 Dosing Regimens of Caspofungin in the Treatment of Invasive Candidiasis in Adults. - MK-0991 High Dose Study

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2005-004504-36-CZ
Enrollment
220
Registered
2005-11-22
Start date
2005-12-20
Completion date
Unknown
Last updated
2019-06-30

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

Conditions

Candidiasis (invasive) MedDRA version: 8.0 Level: LLT Classification code 10007152

Interventions

Trade Name: CANCIDAS™ Product Name: CANCIDAS™ Product Code: MK-0991 Pharmaceutical Form: Powder for solution for infusion INN or Propose
70-

Sponsors

Merck & Co., Inc.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Clinical and microbiological (culture-proven) evidence of blood stream &/or systemic Candida infections Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 1) Possible Candida contamination 2) Candida colonization ( non invasive infection), or Candida involvement of urine, heart valve, ,bone, cerebral spinal fluid, or prosthetic devices. 3) Acute or moderately severe liver disease 4) Abnormal liver function tests 5) Abnormal blood clotting for patients on blood thinners

Design outcomes

Primary

MeasureTime frame
Main Objective: To compare in patients receiving caspofungin 50 mg daily (following a 70-mg loading dose on Day 1) versus caspofungin 150 mg daily for the treatment of invasive candidiasis, (1) the proportion of patients developing significant drug-related adverse experiences (serious drug-related adverse experiences or drug-related adverse experiences leading to caspofungin discontinuation) while on caspofungin study therapy or during the immediate 14-day post-caspofungin therapy period.;Secondary Objective: Secondary objectives : To compare in patients receiving caspofungin 50 mg daily (following a 70-mg loading dose on Day 1) versus caspofungin 150 mg daily for the treatment of invasive candidiasis the proportion of patients with a favorable overall response (favorable clinical response and a favorable microbiologic response) at the end of caspofungin study therapy;Primary end point(s): Evaluate the safety of standard (50mg) versus a higher dose(150mg) of MK 0991in patients treated for invasive candidiasis , by the proportion of patients who develop significant drug related adverse events—

Countries

Belgium, Czech Republic, Germany, Italy, Latvia, Portugal

Outcome results

None listed

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