NCT00082524

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).

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Apr 2004

Typical duration for phase_2

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2004

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 11, 2004

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 13, 2004

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2007

Completed
Last Updated

February 23, 2017

Status Verified

February 1, 2017

Enrollment Period

3.2 years

First QC Date

May 11, 2004

Last Update Submit

February 20, 2017

Conditions

AspergillosisCandidiasis

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (2)

  • 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

Interventions

caspofungin acetateDRUG

Duration of Treatment - 7-90 days

Also known as: MK0991

Eligibility Criteria

Age3 Months - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
* Children, 3 months through 17 years of age, * with esophageal candidiasis or * invasive candidiasis or * children requiring salvage treatment of invasive aspergillosis.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Related Publications (1)

  • Zaoutis TE, Jafri HS, Huang LM, Locatelli F, Barzilai A, Ebell W, Steinbach WJ, Bradley J, Lieberman JM, Hsiao CC, Seibel N, Laws HJ, Gamba M, Petrecz M, Taylor AF, Strohmaier KM, Chow JW, Kartsonis NA, Ngai AL. A prospective, multicenter study of caspofungin for the treatment of documented Candida or Aspergillus infections in pediatric patients. Pediatrics. 2009 Mar;123(3):877-84. doi: 10.1542/peds.2008-1158.

    PMID: 19255017BACKGROUND

MeSH Terms

Conditions

AspergillosisCandidiasis

Interventions

Caspofungin

Condition Hierarchy (Ancestors)

MycosesBacterial Infections and MycosesInfections

Intervention Hierarchy (Ancestors)

LipopeptidesLipidsPeptidesAmino Acids, Peptides, and ProteinsEchinocandinsPeptides, Cyclic

Study Officials

  • Medical Monitor

    Merck Sharp & Dohme LLC

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 11, 2004

First Posted

May 13, 2004

Study Start

April 1, 2004

Primary Completion

July 1, 2007

Study Completion

July 1, 2007

Last Updated

February 23, 2017

Record last verified: 2017-02