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

Fungal Infection Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00635648
• Other study ID #: 0991-066
• Secondary ID: 2008_001
• Status: Completed
• Phase: Phase 3
• First received: February 29, 2008
• Last updated: September 7, 2015
• Start date: January 2008
• Est. completion date: May 2011

Study information

• Verified date: September 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: May 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Candidiasis
• Candidiasis, Invasive
• Fungal Infection
• Mycoses

Intervention

Drug:
• caspofungin acetate
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

References & Publications (1)

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 Infe

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With One or More Drug-related Serious Adverse Events	A serious adverse event is one that results in death, disability/incapacity, or hospitalization or is life threatening, a congenital anomaly or birth defect, cancer, an overdose, or otherwise jeopardizes the patient and may require medical intervention.; A drug-related adverse event is a determination by the investigator physician that the study drug caused the event based on exposure, time course, likely cause, dechallenge (event resolved/improved when drug was discontinued), rechallenge (event resolved/improved when drug was re-introduced), and consistency with the drug profile.	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)	Yes
Secondary	Number of Participants With One or More Drug-related Adverse Events	A drug-related adverse event is a determination by the investigator physician that the study drug caused the event based on exposure, time course, likely cause, dechallenge (event resolved/improved when drug was discontinued), rechallenge (event resolved/improved when drug was re-introduced), and consistency with the drug profile.	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)	Yes
Secondary	Number of Participants Who Discontinued Due to a Drug-related Adverse Event	A drug-related adverse event is a determination by the investigator physician that the study drug caused the event based on exposure, time course, likely cause, dechallenge (event resolved/improved when drug was discontinued), rechallenge (event resolved/improved when drug was re-introduced), and consistency with the drug profile.	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)	Yes
Secondary	Number of Participants With Favorable Overall Response for Esophageal Candidiasis or Invasive Candidiasis	Efficacy response for esophageal candidiasis was based on clinical and endoscopic criteria; favorable responses included complete and partial improvement in symptoms and endoscopic lesions.; Efficacy response for invasive candidiasis was based on microbiological and clinical assessments; favorable responses required both favorable microbiological response (i.e., eradication or presumptive eradication based on symptoms, physical exam, and non-invasive tests) and complete or partial clinical response.	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)	No

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