NCT00082537

Brief Summary

This study is a double-blind, randomized study of MK0991 versus liposomal amphotericin B in the empirical treatment of pediatric patients (ages 2 through 17 years) who have an absolute neutrophil count (ANC) below 500/microliter and who have fever despite broad antibiotic coverage. Such patients would be candidates for empirical therapy with an intravenous anti-fungal agent.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Apr 2004

Status
completed

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

Trial Relationships

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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
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2006

Completed
Last Updated

February 23, 2017

Status Verified

February 1, 2017

Enrollment Period

2.5 years

First QC Date

May 11, 2004

Last Update Submit

February 20, 2017

Conditions

NeutropeniaFever

Outcome Measures

Primary Outcomes (1)

  • To estimate the proportion of patients treated with caspofungin reporting one or more clinical and/or laboratory drug-related adverse experience(s) during the study drug therapy period plus 14 days posttherapy

Secondary Outcomes (1)

  • Proportion of patients with a favorable overall response

Interventions

caspofungin acetateDRUG

Duration of Treatment: 28-90 days

Also known as: MK0991
Comparator: AmBisomeDRUG

Duration of Treatment: 28-90 days

Eligibility Criteria

Age2 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Patients who are 2 through 17 years of age
  • Absolute Neutrophil Count (ANC) is below 500/microliter
  • Have persistent fever (at least 4 days) despite antibiotic therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Maertens JA, Madero L, Reilly AF, Lehrnbecher T, Groll AH, Jafri HS, Green M, Nania JJ, Bourque MR, Wise BA, Strohmaier KM, Taylor AF, Kartsonis NA, Chow JW, Arndt CA, DePauw BE, Walsh TJ; Caspofungin Pediatric Study Group. A randomized, double-blind, multicenter study of caspofungin versus liposomal amphotericin B for empiric antifungal therapy in pediatric patients with persistent fever and neutropenia. Pediatr Infect Dis J. 2010 May;29(5):415-20. doi: 10.1097/INF.0b013e3181da2171.

    PMID: 20431381RESULT

MeSH Terms

Conditions

NeutropeniaFever

Interventions

Caspofungin

Condition Hierarchy (Ancestors)

AgranulocytosisLeukopeniaCytopeniaHematologic DiseasesHemic and Lymphatic DiseasesLeukocyte DisordersBody Temperature ChangesSigns and SymptomsPathological Conditions, Signs and Symptoms

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
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
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

October 1, 2006

Study Completion

October 1, 2006

Last Updated

February 23, 2017

Record last verified: 2017-02