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

Aspergillosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01165320
• Other study ID #: 0991-074
• Secondary ID: 132240
• Status: Completed
• Phase: Phase 2
• Start date: July 6, 2010
• Est. completion date: September 17, 2013

Study information

• Verified date: July 2018
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: September 17, 2013
• Est. primary completion date: September 17, 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Months to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Aspergillosis
• Candidiasis
• Candidiasis, Esophageal
• Candidiasis, Invasive

Intervention

Drug:
• Caspofungin

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

References & Publications (1)

Mori M, Imaizumi M, Ishiwada N, Kaneko T, Goto H, Kato K, Hara J, Kosaka Y, Koike K, Kawamoto H, Maeda N, Yoshinari T, Kishino H, Takahashi K, Kawahara S, Kartsonis NA, Komada Y. Pharmacokinetics, efficacy, and safety of caspofungin in Japanese pediatric — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With an Overall Favorable Response to Therapy	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.	Invasive candidiasis: up to 56 days; aspergillosis: up to 84 days
Primary	Percentage of Participants With One or More Drug-Related Adverse Experiences	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.	Invasive candidiasis: up to 70 days; aspergillosis: up to 98 days