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

Primary Purpose

Fungal Infection

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
caspofungin acetate
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fungal Infection

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Caspofungin 50 mg Intravenous (IV)

    Arm Description

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    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.
    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.
    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.

    Full Information

    First Posted
    February 29, 2008
    Last Updated
    February 21, 2017
    Sponsor
    Merck Sharp & Dohme LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00635648
    Brief Title
    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

    2. Study Status

    Record Verification Date
    February 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2008 (undefined)
    Primary Completion Date
    May 2011 (Actual)
    Study Completion Date
    May 2011 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Merck Sharp & Dohme LLC

    4. Oversight

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Fungal Infection

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    63 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Caspofungin 50 mg Intravenous (IV)
    Arm Type
    Experimental
    Intervention Type
    Drug
    Intervention Name(s)
    caspofungin acetate
    Other Intervention Name(s)
    MK0991, Cancidas®
    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.
    Primary Outcome Measure Information:
    Title
    Number of Participants With One or More Drug-related Serious Adverse Events
    Description
    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.
    Time Frame
    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 Outcome Measure Information:
    Title
    Number of Participants With One or More Drug-related Adverse Events
    Description
    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.
    Time Frame
    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)
    Title
    Number of Participants Who Discontinued Due to a Drug-related Adverse Event
    Description
    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.
    Time Frame
    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)
    Title
    Number of Participants With Favorable Overall Response for Esophageal Candidiasis or Invasive Candidiasis
    Description
    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.
    Time Frame
    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)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Medical Monitor
    Organizational Affiliation
    Merck Sharp & Dohme LLC
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf http://engagezone.msd.com/ds_documentation.php
    Citations:
    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]
    Results Reference
    result

    Learn more about this trial

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

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