MK0991 Versus Amphotericin B for Empirical Therapy in Febrile, Neutropenic Pediatric Patients (0991-044)

Fever Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00082537
• Other study ID #: 0991-044
• Secondary ID: Formerly-0404ETP
• Status: Completed
• Phase: Phase 2
• First received: May 11, 2004
• Last updated: February 20, 2017
• Start date: April 2004
• Est. completion date: October 2006

Study information

• Verified date: February 2017
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: October 2006
• Est. primary completion date: October 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Fever
• Neutropenia

Intervention

Drug:
• caspofungin acetate
Duration of Treatment: 28-90 days
• Comparator: AmBisome
Duration of Treatment: 28-90 days

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

References & 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, mu — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Proportion of patients with a favorable overall response