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

Merck Sharp & Dohme LLC20 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Candidiasis, Esophageal Candidiasis, Invasive Aspergillosis

Interventions

CaspofunginDRUG

Eligibility

Sex: ALLMin age: 3 MonthsMax age: 17 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: Invasive candidiasis: up to 56 days; aspergillosis: up to 84 days

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.

Time frame: Invasive candidiasis: up to 70 days; aspergillosis: up to 98 days

Data from ClinicalTrials.gov

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