Daptomycin Versus Placebo in Patients With Neutropenia and Fever
Stopped early · Phase 3 · Has a placebo group
Conditions studied: Febrile Neutropenia
In brief
The purpose of this study is to evaluate the benefits and side effects of daptomycin compared to placebo for the treatment of neutropenic fever.
Key facts
- Study ID
- NCT01216241
- Run by
- University of Rochester
- People needed
- 36
- Starts
- 2011-04-01
- Expected to finish
- 2013-04-01
- Last updated by the study team
- 2014-04-10
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- University of Rochester Medical Center — Rochester, New York, United States
Full record on ClinicalTrials.gov
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