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

Phase 2

Completed

• Conditions: Aspergillosis; Candidiasis

• Registration Number: NCT00082524
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2004-04
• Study First Submitted: 2004-05-11
• Study First Submitted QC: 2004-05-12
• Study First Posted: 2004-05-13
• Primary Completion: 2007-07
• Study Completion: 2007-07
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-20
• Last Update Posted: 2017-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
The proportion of patients with a favorable efficacy response to caspofungin therapy in each infection type
The proportion of patients who discontinued due to a drug-related AE or who have a serious drug-related AE