Status:
TERMINATED
Daptomycin Versus Placebo in Patients With Neutropenia and Fever
Lead Sponsor:
University of Rochester
Collaborating Sponsors:
Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Conditions:
Febrile Neutropenia
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2013
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT01216241
Start Date
April 1 2011
End Date
April 1 2013
Last Update
April 10 2014
Active Locations (1)
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1
University of Rochester Medical Center
Rochester, New York, United States, 14642