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

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).

Completed

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Key information

Conditions

Aspergillosis Bacterial Infections and Mycoses Candidiasis Infections Mycoses

Age range

3 month–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

caspofungin acetate

Drug

Duration of Treatment - 7-90 days

Other names: MK0991

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

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

A Multicenter, Open-Label, Noncomparative Study to Evaluate the Safety, Tolerability, and Efficacy of Caspofungin Acetate in Children With Documented Candida or Aspergillus Infections

Important dates

Study start: 2004
Primary completion: 2007
Study completion: 2007
First posted: May 13, 2004
Registry last updated: Feb 23, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed