MK0991 Versus Amphotericin B for Empirical Therapy in Febrile, Neutropenic Pediatric Patients (0991-044)
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ClinicalTrials.gov Identifier: NCT00082537 |
Recruitment Status :
Completed
First Posted : May 13, 2004
Last Update Posted : February 23, 2017
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Neutropenia Fever | Drug: caspofungin acetate Drug: Comparator: AmBisome | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
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 : | April 2004 |
Actual Primary Completion Date : | October 2006 |
Actual Study Completion Date : | October 2006 |

- Drug: caspofungin acetate
Duration of Treatment: 28-90 daysOther Name: MK0991
- Drug: Comparator: AmBisome
Duration of Treatment: 28-90 days
- 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
- Proportion of patients with a favorable overall response

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Ages Eligible for Study: | 2 Years to 17 Years (Child) |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00082537
Study Director: | Medical Monitor | Merck Sharp & Dohme LLC |

Publications of Results:
Responsible Party: | Merck Sharp & Dohme LLC |
ClinicalTrials.gov Identifier: | NCT00082537 |
Other Study ID Numbers: |
0991-044 Formerly-0404ETPP MK0991-044 2004_101 |
First Posted: | May 13, 2004 Key Record Dates |
Last Update Posted: | February 23, 2017 |
Last Verified: | February 2017 |
Neutropenia Fever Body Temperature Changes Agranulocytosis Leukopenia Leukocyte Disorders Hematologic Diseases Caspofungin |
Liposomal amphotericin B Antifungal Agents Anti-Infective Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Antiprotozoal Agents Antiparasitic Agents |