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

A Study of MK-0991 in Japanese Children and Adolescents With Documented Candida or Aspergillus Infections (MK-0991-074)
This study is currently recruiting participants.
Verified June 2012 by Merck

First Received on July 15, 2010.  
Last Updated on June 26, 2012  
History of Changes
Sponsor: Merck
Information provided by (Responsible Party): Merck
ClinicalTrials.gov Identifier: NCT01165320
  Purpose

The study estimates the Safety, Efficacy, and Pharmacokinetics of MK-0991 in Japanese Children and Adolescents with Documented Candida or Aspergillus Infections.

Condition Intervention Phase
Fungal Infection Drug: MK-0991 (caspofungin) Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
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:

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: January 2013
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)

Arms

Assigned Interventions
Experimental: 1

MK-0991(caspofungin)
Drug: MK-0991 (caspofungin)

MK-0991 (caspofungin) therapy as a single loading dose of 70 mg/m2 on Day 1, followed by 50 mg/m2 as a single once-daily dose on all subsequent days. A dose escalation of MK-0991 to 70 mg/m2/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 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

  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 spp. or Aspergillus spp.
  • Patient is 3 months to 17 years of age

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
Tokyo, Japan
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: June 26, 2012
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Additional relevant MeSH terms:

Mycoses
Aspergillosis
Caspofungin
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 21, 2012

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