MK0991 Versus Amphotericin B for Empirical Therapy in Febrile, Neutropenic Pediatric Patients (0991-044)
Sponsor
Merck Sharp & Dohme Corp. (Industry)
Overall Status
Completed
CT.gov ID
NCT00082537
Collaborator
(none)
100
30
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
100 participants
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
A Multicenter, Double-Blind, Randomized, Comparative Study to Evaluate the Safety, Tolerability, and Efficacy of Caspofungin Versus (Amphotericin B) Liposome for Injection as Empirical Therapy in Pediatric Patients With Persistent Fever and Neutropenia
Study Start Date
:
Apr 1, 2004
Actual Primary Completion Date
:
Oct 1, 2006
Actual Study Completion Date
:
Oct 1, 2006
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- Proportion of patients with a favorable overall response []
Eligibility Criteria
Criteria
Ages Eligible for Study:
2 Years
to 17 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
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
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Merck Sharp & Dohme Corp.
Investigators
- Study Director: Medical Monitor, Merck Sharp & Dohme Corp.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00082537
Other Study ID Numbers:
- 0991-044
- Formerly-0404ETPP
- MK0991-044
- 2004_101
First Posted:
May 13, 2004
Last Update Posted:
Feb 23, 2017
Last Verified:
Feb 1, 2017