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CompletedNCT00082537Updated Feb 23, 2017

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

A Phase 2 interventional study of caspofungin acetate and Comparator: AmBisome in Neutropenia and Fever, sponsored by Merck Sharp & Dohme LLC. Completed. Open to participants aged 2 Years to 17 Years. Per ClinicalTrials.gov, last updated 2017-02-23.

Sponsored by Merck Sharp & Dohme LLC (part of Merck & Co., Inc) · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
2 Years to 17 Years
Sex
All
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Study 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.

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Conditions studied

  • Neutropenia
  • Fever

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03

In context

Neutropenia

405 studies on the registry are indexed under Neutropenia; 60 are open to participants now.

This study's enrollment of 100 is close to the median of 93 across 285 interventional studies indexed under Neutropenia.

Browse Neutropenia studies →

Lead sponsor

Merck Sharp & Dohme LLC is the lead sponsor of 2,159 studies on the registry; 133 are open to participants now.

Of its 497 completed or terminated interventional studies of FDA-regulated products, 369 (74%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
2 Years to 17 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

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
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Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
Double (Participant, Investigator)
Enrollment
100 participants (actual)

Interventions

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What researchers measure

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

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Study locations

No study locations are listed for this record.

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References and documents

Publications

  • 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. PubMed 20431381 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 23, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00082537
Responsible party
Sponsor
First posted
May 13, 2004
Start date
Apr 2004
Primary completion
Oct 2006
Completion
Oct 2006
Last update
Feb 23, 2017

Study contacts

Medical Monitor
study director · Merck Sharp & Dohme LLC
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2017. You cannot join it, but the record below documents what was studied.

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