Status:
COMPLETED
A Study of Caspofungin Acetate (MK0991) for the Treatment of Esophageal Candidiasis or Invasive Candidiasis in Chinese Adults (MK-0991-066)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Fungal Infection
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2011
Estimated Enrollment :
63 Patients enrolled
Trial Details
Trial ID
NCT00635648
Start Date
January 1 2008
End Date
May 1 2011
Last Update
March 24 2017
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