A Study of Caspofungin Acetate (MK0991) for the Treatment of Esophageal Candidiasis or Invasive Candidiasis in Chinese Adults (MK-0991-066)
Condition: Fungal Infection
MeSH terms: Candidiasis; Mycoses; Candidiasis, Invasive
Intervention: caspofungin acetate
Intervention description: 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 MeSH terms: Caspofungin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 63.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

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.
    

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