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Phase 3 N=63 Treatment

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

Fungal Infection

Enrolled (actual)
63
Serious AEs
22.2%
Results posted
May 2012
Primary outcome: Primary: Number of Participants With One or More Drug-related Serious Adverse Events — 0 Participants

Study Design & Population

Study type
Interventional
Phase
Phase 3
Interventions
caspofungin acetate (Drug)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Merck Sharp & Dohme LLC
Primary completion
May 2011

Outcome Measures

OutcomeResultp-value
PRIMARY
Number of Participants With One or More Drug-related Serious Adverse Events
SECONDARY
Number of Participants With One or More Drug-related Adverse Events
31
SECONDARY
Number of Participants Who Discontinued Due to a Drug-related Adverse Event
1
SECONDARY
Number of Participants With Favorable Overall Response for Esophageal Candidiasis or Invasive Candidiasis
36

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 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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00635648). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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