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

Last updated: February 21, 2017
Sponsor: Merck Sharp & Dohme Corp.
Overall Status: Completed

Phase

3

Condition

Sunspot Fungus (Tinea Versicolor)

Yeast Infections

Sexually Transmitted Diseases (Stds)

Treatment

N/A

Clinical Study ID

NCT00635648
0991-066
2008_001
  • Ages > 18
  • All Genders

Study 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

Inclusion Criteria:

  • Participant has a confirmed diagnosis of esophageal candidiasis or invasivecandidiasis 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 candidiasisand positive stain or wetmount KOH of brushing or biopsy from endoscopy followed bypositive 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 othernormally 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 determinationof >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 theparticipant's normal baseline

  • Signs of inflammation at a site infected with Candida

Exclusion

Exclusion Criteria:

  • Participant has any of the following abnormal laboratory values: InternationalNormalization 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]) oralanine aminotransferase (ALT, or serum glutamic pyruvic transaminase [SGPT]) >5 times theupper 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 onendoscopy with high likelihood of another non-Candida pathogen

  • Participant has other esophageal pathology on endoscopy that is unrelated to acuteesophageal candidiasis

  • FOR INVASIVE CANDIDIASIS

  • Participant has evidence of infection limited to a positive culture for Candida fromurine, sputum, catheter tip, indwelling drain, or mucosal or superficial skin surface

  • Participant has suspected Candida endocarditis, osteomyelitis, or meningitis

Study Design

Total Participants: 63
Study Start date:
January 01, 2008
Estimated Completion Date:
May 31, 2011