Back to resultsDaptomycin Versus Placebo in Patients With Neutropenia and Fever
Primary Purpose
Febrile Neutropenia
Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Daptomycin
Saline Placebo
Daptomycin
Sponsored by
About this trial
This is an interventional treatment trial for Febrile Neutropenia
Eligibility Criteria
Inclusion Criteria:
- Patients in the above categories who are currently undergoing chemotherapy.
- Patients at least 18 of age.
- Patient expected to reach an absolute granulocyte count of <100 cells/mm3
- Patients who have given written consent because of the above criteria must have at least one temperature of greater or equal to 38.3° or temperatures > 38o on at least two occasions before study drug is administered.
Exclusion Criteria:
- Patients with lymphoma or with solid tumor undergoing initial chemotherapy. Their neutropenia is of insufficient duration for adequate test of the value of an anti-gram positive antibiotic.
- Patients undergoing auto-transplantation, for the same reason as above.
- Patients with evidence of a clinical infection such as presence of a pulmonary infiltrate by x-ray or clinical evidence for the presence of cellulitis.
- Patients who have received daptomycin in the two weeks prior to enrollment.
- Patients with concomitant use of vancomycin.
- Patients with creatinine clearance < 30 ml/min or CPK > 3x normal
- Patients with significant hepatic dysfunction, defined as baseline liver function tests > 5x above normal.
- Patients with known allergy to daptomycin.
- Patients previously in this study.
- Women of child bearing age who are either lactating or pregnant (as evidenced by a positive urine pregnancy test or positive serum beta-HCG).
- Patients previously enrolled in this study.
Sites / Locations
- University of Rochester Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Daptomycin
Saline Placebo
Arm Description
Daptomycin intravenous 8mg/kg once per day 5-10 days.
Saline solution
Outcomes
Primary Outcome Measures
Percentage of Afebrile Neutropenic Subjects
To determine whether the percentage of neutropenic subjects that become afebrile by five days after fever first develops.
Secondary Outcome Measures
Full Information
NCT ID
NCT01216241
First Posted
October 4, 2010
Last Updated
March 4, 2014
Sponsor
University of Rochester
Collaborators
Cubist Pharmaceuticals LLC
1. Study Identification
Unique Protocol Identification Number
NCT01216241
Brief Title
Daptomycin Versus Placebo in Patients With Neutropenia and Fever
Official Title
A Single Center, Double-Blind, Randomized, Comparative Study to Evaluate the Efficacy and Safety of Daptomycin Versus Placebo in Patients With Neutropenia and Fever.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2014
Overall Recruitment Status
Terminated
Why Stopped
The study has shown futility and the objectives could not be reached without enrolling a very large number of subjects.
Study Start Date
April 2011 (undefined)
Primary Completion Date
April 2013 (Actual)
Study Completion Date
April 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Rochester
Collaborators
Cubist Pharmaceuticals LLC
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
Detailed Description
To determine whether the percentage of neutropenic subjects that become afebrile by five days after fever first develops is higher when daptomycin compared to placebo is added at the same time as anti gram-negative therapy. The five day time point is selected because it is at this point where it is recommended to add antifungal therapy to the treatment regimen if the patient is still febrile.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Febrile Neutropenia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Daptomycin
Arm Type
Active Comparator
Arm Description
Daptomycin intravenous 8mg/kg once per day 5-10 days.
Arm Title
Saline Placebo
Arm Type
Placebo Comparator
Arm Description
Saline solution
Intervention Type
Drug
Intervention Name(s)
Daptomycin
Other Intervention Name(s)
Cubicin
Intervention Description
8 MG/KG IV
Intervention Type
Other
Intervention Name(s)
Saline Placebo
Intervention Description
50 ml normal saline once daily
Intervention Type
Drug
Intervention Name(s)
Daptomycin
Other Intervention Name(s)
Cubicin
Intervention Description
8 mg/kg once daily
Primary Outcome Measure Information:
Title
Percentage of Afebrile Neutropenic Subjects
Description
To determine whether the percentage of neutropenic subjects that become afebrile by five days after fever first develops.
Time Frame
5 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients in the above categories who are currently undergoing chemotherapy.
Patients at least 18 of age.
Patient expected to reach an absolute granulocyte count of <100 cells/mm3
Patients who have given written consent because of the above criteria must have at least one temperature of greater or equal to 38.3° or temperatures > 38o on at least two occasions before study drug is administered.
Exclusion Criteria:
Patients with lymphoma or with solid tumor undergoing initial chemotherapy. Their neutropenia is of insufficient duration for adequate test of the value of an anti-gram positive antibiotic.
Patients undergoing auto-transplantation, for the same reason as above.
Patients with evidence of a clinical infection such as presence of a pulmonary infiltrate by x-ray or clinical evidence for the presence of cellulitis.
Patients who have received daptomycin in the two weeks prior to enrollment.
Patients with concomitant use of vancomycin.
Patients with creatinine clearance < 30 ml/min or CPK > 3x normal
Patients with significant hepatic dysfunction, defined as baseline liver function tests > 5x above normal.
Patients with known allergy to daptomycin.
Patients previously in this study.
Women of child bearing age who are either lactating or pregnant (as evidenced by a positive urine pregnancy test or positive serum beta-HCG).
Patients previously enrolled in this study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert F Betts, MD
Organizational Affiliation
University of Rochester
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Rochester Medical Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Daptomycin Versus Placebo in Patients With Neutropenia and Fever
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