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A Study of Caspofungin (MK-0991) in Japanese Children and Adolescents With Documented Candida or Aspergillus Infections (MK-0991-074 AM1)

This study is currently recruiting participants.
Verified March 2013 by Merck
Sponsor:
Information provided by (Responsible Party):
Merck
ClinicalTrials.gov Identifier:
NCT01165320
First received: July 15, 2010
Last updated: March 13, 2013
Last verified: March 2013
History of Changes
  Purpose

The study estimates the safety, efficacy, and pharmacokinetics of caspofungin (MK-0991) in Japanese children and adolescents with documented Candida or Aspergillus infections.


Condition Intervention Phase
Fungal Infection
 Drug: Caspofungin
 Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multicenter, Noncomparative, Open-label Study to Estimate the Safety, Efficacy, and Pharmacokinetics of MK-0991 (Caspofungin) in Japanese Children and Adolescents With Documented Candida or Aspergillus Infections

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:
  • Overall response assessment for each infection category (esophageal candidiasis, invasive candidiasis, and aspergillosis) [ Time Frame: End of study therapy (7 to 84 days) ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: July 2010
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Caspofungin Drug: Caspofungin

Caspofungin (MK-0991) therapy as a single loading dose of 70 mg/m^2 intravenously on Day 1 (maximum not to exceed 70 mg), followed by 50 mg/m^2 as a single once-daily dose on all subsequent days (maximum of 70 mg daily). A dose escalation of caspofungin to 70 mg/m^2/day, at the discretion of the investigator or sub-investigator, is allowed in patients who have not responded adequately after 4 days provided the study drug has been well tolerated (maximum should still not exceed 70 mg).

Maximum and minimum treatment periods for each infection category (esophageal candidiasis, invasive candidiasis, and aspergillosis) are as follows:

Aspergillosis: 14 to 84 days; Invasive candidiasis: 14 to 56 days; Esophageal candidiasis: 7 to 28 days

Other Names:
  • MK-0991
  • CANCIDAS®

  Eligibility

Ages Eligible for Study:   3 Months to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Japanese patients in whom a causative fungus is detected before treatment with the study drug or patients with strongly suspected deep-seated fungal infection due to Candida species (spp.) or Aspergillus spp.

Exclusion Criteria:

  • Patients with mycoses other than ones due to Candida spp. or Aspergillus spp.
  • Patients who will receive other systemic antifungal agents for the first time in screening period
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01165320

Contacts
Contact: Toll Free Number 1-888-577-8839

Locations
Japan
MSD K.K. Recruiting
Chiyoda-Ku, Tokyo, Japan, 102-8667
Contact: Japan Call Center     81-3-6272-1957        
Sponsors and Collaborators
Merck
  More Information

No publications provided

Responsible Party: Merck
ClinicalTrials.gov Identifier: NCT01165320     History of Changes
Other Study ID Numbers: 0991-074
Study First Received: July 15, 2010
Last Updated: March 13, 2013
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Additional relevant MeSH terms:
Mycoses
Aspergillosis
Caspofungin
Echinocandins
 Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013