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

• Status: Completed
• Trial end date: 2011-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: Caspofungin; Echinocandins

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