Clinical trial NCT00635648: A Study of Caspofungin Acetate (MK0991) for the Treatment of Esophageal Candidiasis or Invasive Candidiasis in Chinese Adults (MK-0991-066)
Official title: A Non-comparative, Multicenter, Open-label Study to Evaluate the Safety, Tolerability, and Efficacy of Caspofungin Acetate (MK-0991) for the Treatment of Esophageal Candidiasis or Invasive Candidiasis in Chinese Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Fungal Infection
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2008-03-14
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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

Primary outcomes:
measure: Number of Participants With One or More Drug-related Serious Adverse Events
timeFrame: First dose of study drug through 14 days post therapy (maximum 28 days of study drug for esophageal candidiasis, 60 days for invasive candidiasis; mean treatment duration of 14 days)
Secondary outcomes:
measure: Number of Participants With One or More Drug-related Adverse Events
timeFrame: First dose of study drug through 14 days post therapy (maximum 28 days of study drug for esophageal candidiasis, 60 days for invasive candidiasis; mean treatment duration of 14 days)
measure: Number of Participants Who Discontinued Due to a Drug-related Adverse Event
timeFrame: First dose of study drug through 14 days post therapy (maximum 28 days of study drug for esophageal candidiasis, 60 days for invasive candidiasis; mean treatment duration of 14 days)
measure: Number of Participants With Favorable Overall Response for Esophageal Candidiasis or Invasive Candidiasis
timeFrame: First dose of study drug through up to 60 days of therapy (maximum 28 days of study drug for esophageal candidiasis, 60 days for invasive candidiasis; mean treatment duration of 14 days)
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Lin DF, Wang JM, Yu YS; Han MZ, Shen ZX, Song SD, Zhang YY. A non-controlled, multicenter, open-label study to evaluate the safety, tolerability, and efficacy of caspofungin acetate for the treatment of invasive candidiasis in Chinese adults . Chin J Infect Chemother. 2014;14(5):379-385. [in Chinese]