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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01165320
First received: July 15, 2010
Last updated: March 20, 2014
Last verified: March 2014
  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
Candidiasis, Esophageal
Candidiasis, Invasive
Aspergillosis
Drug: Caspofungin
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel 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 Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Percentage of Participants With an Overall Favorable Response to Therapy [ Time Frame: Invasive candidiasis: up to 56 days; aspergillosis: up to 84 days ] [ Designated as safety issue: No ]
    Invasive candidiasis: favorable overall response required resolved clinical findings and negative culture test for Candida species on follow-up. If Candida species were not observed in the baseline blood culture, favorable overall response required resolved clinical findings and resolved or improved radiographic findings. Aspergillosis: favorable overall response required resolved, improved, or unchanged clinical findings and resolved or improved radiographic findings, or resolved or improved clinical findings and resolved, improved, or stable radiographic findings.

  • Percentage of Participants With One or More Drug-Related Adverse Experiences [ Time Frame: Invasive candidiasis: up to 70 days; aspergillosis: up to 98 days ] [ Designated as safety issue: Yes ]
    An adverse experience (AE) is defined as any unfavorable or unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug. Any worsening of a preexisting condition which is temporally associated with the use of the study drug is also an AE. A drug-related AE is one judged to be definitely, probably, or possibly related to the study drug.


Enrollment: 20
Study Start Date: July 2010
Study Completion Date: September 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Participants with Esophageal Candidiasis
Candida infection is strongly suspected based on clinical symptoms and the participant's clinical course, white moss (plaque) is observed on the esophageal mucosa, and therapy via intravenous infusion is judged to be suitable for the present episode of esophageal candidiasis. 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). The minimum and maximum treatment duration was 7 and 28 days, respectively.
Drug: Caspofungin
Other Names:
  • MK-0991
  • CANCIDAS®
Experimental: Participants with Invasive Candidiasis
Candida infection is strongly suspected based on the presence of refractory fever not responding to an antibiotic agent, or clinical symptoms at the site of disease, or the participant's clinical course. In addition, at least 1 of the following criteria must be met: 1) Candida infection is strongly suspected based on radiographic imaging findings and positive serological test for fungus, 2) yeast is observed by direct microscopy or histopathological test of tissue biopsied from the site of disease, or 3) Candida species are observed by culture test of specimens sampled from the site of disease. 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). The minimum and maximum treatment duration was 14 and 56 days, respectively.
Drug: Caspofungin
Other Names:
  • MK-0991
  • CANCIDAS®
Experimental: Participants with Aspergillosis
Aspergillus infection is strongly suspected based on clinical symptoms and the participant's clinical course, and characteristic radiographic imaging findings are observed. In addition, at least 1 of the following criteria must be met: 1) risk factors predisposing to an Aspergillus infection, 2) positive serological test for Aspergillus, 3) acute-branching mold with separated hyphae are observed by direct microscopy or histopathological test, or 4) Aspergillus species are observed by culture test. 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). The minimum and maximum treatment duration was 14 and 84 days, respectively.
Drug: Caspofungin
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01165320     History of Changes
Other Study ID Numbers: 0991-074
Study First Received: July 15, 2010
Results First Received: March 20, 2014
Last Updated: March 20, 2014
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Additional relevant MeSH terms:
Aspergillosis
Candidiasis
Candidiasis, Invasive
Hyalohyphomycosis
Dermatomycoses
Skin Diseases, Infectious
Infection
Mycoses
Skin Diseases
Caspofungin
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014