Daptomycin Versus Placebo in Patients With Neutropenia and Fever
This study has been terminated.
(The study has shown futility and the objectives could not be reached without enrolling a very large number of subjects.)
Information provided by (Responsible Party):
Robert Betts, University of Rochester
First received: October 4, 2010
Last updated: March 4, 2014
Last verified: March 2014
The purpose of this study is to evaluate the benefits and side effects of daptomycin compared to placebo for the treatment of neutropenic fever.
Other: Saline Placebo
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
||A Single Center, Double-Blind, Randomized, Comparative Study to Evaluate the Efficacy and Safety of Daptomycin Versus Placebo in Patients With Neutropenia and Fever.
Primary Outcome Measures:
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||April 2013 (Final data collection date for primary outcome measure)
Active Comparator: Daptomycin
Daptomycin intravenous 8mg/kg once per day 5-10 days.
8 MG/KG IV
Other Name: Cubicin
8 mg/kg once daily
Other Name: Cubicin
Placebo Comparator: Saline Placebo
Other: Saline Placebo
50 ml normal saline once daily
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.
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- 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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01216241
|University of Rochester Medical Center
|Rochester, New York, United States, 14642 |
University of Rochester
||Robert F Betts, MD
||University of Rochester
No publications provided
||Robert Betts, Principal Investigator, University of Rochester
History of Changes
|Other Study ID Numbers:
|Study First Received:
||October 4, 2010
|Results First Received:
||November 6, 2013
||March 4, 2014
||United States: Food and Drug Administration
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on August 18, 2014