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

Merck Sharp & Dohme (MSD)

Status and phase

Completed

Phase 3

Conditions

Fungal Infection

Treatments

Drug: caspofungin acetate

Study type

Interventional

Funder types

Industry

Identifiers

NCT00635648

2008_001

0991-066

Details and patient eligibility

About

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.

Enrollment

63 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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