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

NCT ID: NCT00635648

Last Updated: 2017-03-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 63 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-01-31
• Study Completion Date: 2011-05-31

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Caspofungin 50 mg Intravenous (IV)

Group Type: EXPERIMENTAL

caspofungin acetate

Intervention Type: 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.

Interventions

caspofungin acetate

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.

Intervention Type: DRUG

Other Intervention Names

MK0991; Cancidas®

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Monitor

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

References

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]

Reference Type: RESULT

Other Identifiers

2008_001

Identifier Type: -

Identifier Source: secondary_id

0991-066

Identifier Type: -

Identifier Source: org_study_id