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Antibiotic
Daptomycin for Febrile Neutropenia
Phase 3
Waitlist Available
Led By Robert F Betts, MD
Research Sponsored by University of Rochester
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 days
Awards & highlights
All Individual Drugs Already Approved
Approved for 5 Other Conditions
Pivotal Trial
Summary
The purpose of this study is to evaluate the benefits and side effects of daptomycin compared to placebo for the treatment of neutropenic fever.
Eligible Conditions
- Febrile Neutropenia
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 5 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 days
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Percentage of Afebrile Neutropenic Subjects
Awards & Highlights
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: DaptomycinActive Control1 Intervention
Daptomycin intravenous 8mg/kg once per day 5-10 days.
Group II: Saline PlaceboPlacebo Group1 Intervention
Saline solution
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Who is running the clinical trial?
Cubist Pharmaceuticals LLCIndustry Sponsor
88 Previous Clinical Trials
22,650 Total Patients Enrolled
Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)Industry Sponsor
88 Previous Clinical Trials
22,650 Total Patients Enrolled
University of RochesterLead Sponsor
869 Previous Clinical Trials
549,726 Total Patients Enrolled
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