Documented Candida or Aspergillus Infections in Pediatric Patients (0991-043)

Merck Sharp & Dohme LLC50 enrolled

Overview

This study is an open label, noncomparative study using an investigational agent for the treatment of documented Candida or Aspergillus infections in pediatric patients (ages 3 months-17 years).

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Aspergillosis Candidiasis

Interventions

caspofungin acetateDRUG

Duration of Treatment - 7-90 days

Eligibility

Sex: ALLMin age: 3 MonthsMax age: 17 Years

Medical Language ↔ Plain English

* Children, 3 months through 17 years of age, * with esophageal candidiasis or * invasive candidiasis or * children requiring salvage treatment of invasive aspergillosis.

Outcomes

Primary Outcomes

The proportion of patients with one or more drug-related clinical or laboratory adverse experience(s)

Secondary Outcomes

The proportion of patients who discontinued due to a drug-related AE or who have a serious drug-related AE

The proportion of patients with a favorable efficacy response to caspofungin therapy in each infection type

Data from ClinicalTrials.gov

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