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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)

Merck Sharp & Dohme (MSD) logo

Merck Sharp & Dohme (MSD)

Status and phase

Completed
Phase 3

Conditions

Invasive Candidiasis

Treatments

Drug: caspofungin acetate

Study type

Interventional

Funder types

Industry

Identifiers

NCT00250432
2005_085
0991-801

Details and patient eligibility

About

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)

Enrollment

204 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

204 participants in 2 patient groups

1
Active Comparator group
Description:
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.
Treatment:
Drug: caspofungin acetate
2
Experimental group
Description:
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.
Treatment:
Drug: caspofungin acetate

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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