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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00082524

Enrollment

Registered

2004-05-13

Start date

2004-04-30

Completion date

2007-07-31

Last updated

2017-02-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aspergillosis, Candidiasis

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).

Interventions

DRUGcaspofungin acetate

Duration of Treatment - 7-90 days

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

3 Months to 17 Years

Healthy volunteers

Inclusion criteria

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
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	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026