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A Multicenter, Randomized, Double-Blind, Comparative Study to Evaluate the Safety, Tolerability, and Efficacy of 2 Dosing Regimens of an Antifungal Drug in the Treatment of Fungal Infections in Adults (0991-801)(COMPLETED)

This study has been completed.
Sponsor:
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00250432
First received: November 4, 2005
Last updated: April 8, 2013
Last verified: April 2013
History of Changes
  Purpose

Comparison of the safety and effectiveness of standard drug dosing versus a daily dose 3 times higher than the standard dose in patients with invasive candidiasis (bloodstream and/or systemic yeast infections)


Condition Intervention Phase
Invasive Candidiasis
 Drug: caspofungin acetate
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

MedlinePlus related topics: Yeast Infections
U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:
  • Number of Patients Who Develop Significant Drug-related Adverse Events. [ Time Frame: 90 Days ] [ Designated as safety issue: Yes ]
    Number of patients with at least 1 significant drug-related adverse event (serious drug-related or drug-related adverse events leading to caspofungin discontinuation) while on caspofungin study therapy or during the immediate 14-day post-caspofungin therapy period.


Secondary Outcome Measures:
  • Number of Patients With a Favorable Overall Response. [ Time Frame: 90 Days ] [ Designated as safety issue: No ]
    Number of patients with a favorable overall response, defined as a clinical response of "cure" or "apparent cure" along with a microbiological response of "eradication" or "presumptive eradication" at the End of Caspofungin Therapy.


Enrollment: 204
Study Start Date: January 2006
Study Completion Date: March 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
50 mg intravenous (IV) infusion (diluted with 9% saline) administered daily (following a 70-mg IV loading dose on Day 1), over the course of ~2 hrs. all patients should be treated with antifungal therapy for at least 14 days following both the improvement in clinical and radiographic signs of disease and the eradication of Candida from culture samples obtained from the invasive site of infection.
 Drug: caspofungin acetate
Caspofungin acetate 50 mg IV infusion (diluted with 9% saline) (following a 70-mg IV loading dose on Day 1); Caspofungin acetate 150 mg IV infusion (diluted with 9% saline) administered daily, over the course of ~2 hrs. Duration of Treatment - 14-90 days.
Experimental: 2
150 mg intravenous (IV) infusion (diluted with 9% saline) administered daily, over the course of ~2 hrs. all patients should be treated with antifungal therapy for at least 14 days following both the improvement in clinical and radiographic signs of disease and the eradication of Candida from culture samples obtained from the invasive site of infection.
 Drug: caspofungin acetate
Caspofungin acetate 50 mg IV infusion (diluted with 9% saline) (following a 70-mg IV loading dose on Day 1); Caspofungin acetate 150 mg IV infusion (diluted with 9% saline) administered daily, over the course of ~2 hrs. Duration of Treatment - 14-90 days.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinical and Laboratory evidence of blood stream &/or systemic candida infections

Exclusion Criteria:

  • Possible candida contamination
  • Candida colonization (non invasive infection), urine, cardiac, bone or brain and prosthetic device infections
  • Acute or moderately severe liver disease
  • Abnormal liver function tests
  • Abnormal blood clotting for patients on blood thinners
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00250432

Sponsors and Collaborators
Merck
Investigators
Study Director: Medical Monitor Merck
  More Information

Additional Information:
MedWatch - FDA maintained medical product safety Information  This link exits the ClinicalTrials.gov site
Merck: Patient & Caregiver U.S. Product Web Site  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier: NCT00250432     History of Changes
Other Study ID Numbers: 2005_085, MK0991-801
Study First Received: November 4, 2005
Results First Received: January 13, 2009
Last Updated: April 8, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Candidiasis
Candidiasis, Invasive
Mycoses
Antifungal Agents
Caspofungin
 Echinocandins
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 17, 2013