A Study of Caspofungin Acetate (MK0991) for the Treatment of Esophageal Candidiasis or Invasive Candidiasis in Chinese Adults (MK-0991-066)

NCT00635648 | Completed Phase 3 Results

• 2 other identifiers: 0991-0662008_001
• Study Type: interventional
• Target: 63
• Locations: 0 countries
• Sites: N/A

Brief Summary

To evaluate the safety, tolerability, and efficacy of caspofungin for the treatment of esophageal candidiasis and invasive candidiasis to support the registration of caspofungin for these indications in China.

Conditions

Fungal Infection

Outcome Measures

Primary Outcomes (1)

• Number of Participants With One or More Drug-related Serious Adverse Events

  A serious adverse event is one that results in death, disability/incapacity, or hospitalization or is life threatening, a congenital anomaly or birth defect, cancer, an overdose, or otherwise jeopardizes the patient and may require medical intervention. A drug-related adverse event is a determination by the investigator physician that the study drug caused the event based on exposure, time course, likely cause, dechallenge (event resolved/improved when drug was discontinued), rechallenge (event resolved/improved when drug was re-introduced), and consistency with the drug profile.

  First dose of study drug through 14 days post therapy (maximum 28 days of study drug for esophageal candidiasis, 60 days for invasive candidiasis; mean treatment duration of 14 days)

Secondary Outcomes (3)

• Number of Participants With One or More Drug-related Adverse Events

  First dose of study drug through 14 days post therapy (maximum 28 days of study drug for esophageal candidiasis, 60 days for invasive candidiasis; mean treatment duration of 14 days)

• Number of Participants Who Discontinued Due to a Drug-related Adverse Event

  First dose of study drug through 14 days post therapy (maximum 28 days of study drug for esophageal candidiasis, 60 days for invasive candidiasis; mean treatment duration of 14 days)

• Number of Participants With Favorable Overall Response for Esophageal Candidiasis or Invasive Candidiasis

  First dose of study drug through up to 60 days of therapy (maximum 28 days of study drug for esophageal candidiasis, 60 days for invasive candidiasis; mean treatment duration of 14 days)

Study Arms (1)

Caspofungin 50 mg Intravenous (IV)

EXPERIMENTAL

Drug: caspofungin acetate

Interventions

caspofungin acetate DRUG

Intravenous (IV) caspofungin acetate 50 mg/day. Participants with esophageal candidiasis will be treated for at least 7 days and for at least 72 hours after symptoms resolve for a maximum of 28 days; participants with invasive candidiasis will have a 70 mg loading dose on study day 1 and will be treated for at least 14 days after the last positive culture of Candida from the blood or other normally sterile body site for a maximum of 60 days; these participants should also have improvement in clinical and radiographic signs of disease for at least 48 hours before completion of the study therapy.

Also known as: MK0991, Cancidas®

Caspofungin 50 mg Intravenous (IV)

Eligibility Criteria

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

You may qualify if:

• Participant has a confirmed diagnosis of esophageal candidiasis or invasive candidiasis for whom IV antifungal therapy is appropriate
• FOR ESOPHAGEAL CANDIDIASIS
• Participant has endoscopic evidence of esophageal candidiasis
• Participant has disease documented by symptoms consistent with esophageal candidiasis and positive stain or wetmount KOH of brushing or biopsy from endoscopy followed by positive culture for Candida or positive histopathologic evidence of Candida infection
• FOR INVASIVE CANDIDIASIS
• Participant has at least 1 positive culture of a Candida species from blood or other normally sterile body site obtained within 96 hours of study entry
• Participant has clinical evidence of infection within 96 hours before study entry
• Temperature \>100\^◦F (37.8\^◦F) on 2 occasions at least 4 hours apart or 1 determination of \>101\^◦F (38.3\^◦F) or clinically significant hypothermia \<96.8\^◦F (36.0\^◦C)
• Systolic blood pressure \<90 or ≥30 mm Hg decrease in systolic blood pressure from the participant's normal baseline
• Signs of inflammation at a site infected with Candida

You may not qualify if:

• Participant has any of the following abnormal laboratory values: International Normalization Ratio (INR) \>1.6 or, if participant is receiving anticoagulants, INR \>4.0; bilirubin \>5 times the upper limit of normal range;
• aspartate aminotransferase (AST, or serum glutamic oxaloacetic transaminase \[SGOT\]) or alanine aminotransferase (ALT, or serum glutamic pyruvic transaminase \[SGPT\]) \>5 times the upper limit of normal range
• FOR ESOPHAGEAL CANDIDIASIS
• Participant has Candida disease limited to the oropharynx
• Participant has another cause of esophagitis or has clearly defined ulcers on endoscopy with high likelihood of another non-Candida pathogen
• Participant has other esophageal pathology on endoscopy that is unrelated to acute esophageal candidiasis
• FOR INVASIVE CANDIDIASIS
• Participant has evidence of infection limited to a positive culture for Candida from urine, sputum, catheter tip, indwelling drain, or mucosal or superficial skin surface
• Participant has suspected Candida endocarditis, osteomyelitis, or meningitis

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related Publications (1)

• Lin DF, Wang JM, Yu YS; Han MZ, Shen ZX, Song SD, Zhang YY. A non-controlled, multicenter, open-label study to evaluate the safety, tolerability, and efficacy of caspofungin acetate for the treatment of invasive candidiasis in Chinese adults . Chin J Infect Chemother. 2014;14(5):379-385. [in Chinese]

  RESULT

MeSH Terms

Conditions

Mycoses

Interventions

Caspofungin

Condition Hierarchy (Ancestors)

Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

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

Limitations and Caveats

This was an open-label non-comparative study with a relatively small sample size.

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: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 29, 2008
• First Posted: March 14, 2008
• Study Start: January 1, 2008
• Primary Completion: May 1, 2011
• Study Completion: May 1, 2011
• Last Updated: March 24, 2017
• Results First Posted: May 28, 2012

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will share