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)

NCT00250432 | Completed Phase 3 Results

• 2 other identifiers: 0991-8012005_085
• Study Type: interventional
• Target: 204
• Locations: 0 countries
• Sites: N/A

Brief Summary

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)

Conditions

Invasive Candidiasis

Outcome Measures

Primary Outcomes (1)

• Number of Patients Who Develop Significant Drug-related Adverse Events.

  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.

  90 Days

Secondary Outcomes (1)

• Number of Patients With a Favorable Overall Response.

  90 Days

Study Arms (2)

1

ACTIVE COMPARATOR

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

2

EXPERIMENTAL

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

Interventions

caspofungin acetate DRUG

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.

1; 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related Publications (1)

• Betts RF, Nucci M, Talwar D, Gareca M, Queiroz-Telles F, Bedimo RJ, Herbrecht R, Ruiz-Palacios G, Young JA, Baddley JW, Strohmaier KM, Tucker KA, Taylor AF, Kartsonis NA; Caspofungin High-Dose Study Group. A Multicenter, double-blind trial of a high-dose caspofungin treatment regimen versus a standard caspofungin treatment regimen for adult patients with invasive candidiasis. Clin Infect Dis. 2009 Jun 15;48(12):1676-84. doi: 10.1086/598933.

  PMID: 19419331 BACKGROUND

MeSH Terms

Conditions

Candidiasis, Invasive

Interventions

Caspofungin

Condition Hierarchy (Ancestors)

Candidiasis; Mycoses; Bacterial Infections and Mycoses; Infections; Invasive Fungal Infections

Intervention Hierarchy (Ancestors)

Lipopeptides; Lipids; Peptides; Amino Acids, Peptides, and Proteins; Echinocandins; Peptides, Cyclic

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Study Officials

• Medical Monitor

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2005
• First Posted: November 8, 2005
• Study Start: January 1, 2006
• Primary Completion: January 1, 2008
• Study Completion: March 1, 2008
• Last Updated: March 24, 2017
• Results First Posted: March 24, 2009

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will share