A Single Center, Double-Blind, Randomized, Comparative Study to Evaluate the Efficacy and Safety of Daptomycin Versus Placebo in Patients With Neutropenia and Fever.
Trial Snapshot
- Phase
- Phase 3
- Status
- Terminated
- Sponsor
- University of Rochester
- Enrollment
- 36
- Locations
- 1
- Primary Endpoint
- Percentage of Afebrile Neutropenic Subjects
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Saline Placebo
Saline solution
Intervention: Saline Placebo (Other)
Daptomycin
Daptomycin intravenous 8mg/kg once per day 5-10 days.
Intervention: Daptomycin (Drug)
Outcomes
Primary Outcomes
Percentage of Afebrile Neutropenic Subjects
Time Frame: 5 days
To determine whether the percentage of neutropenic subjects that become afebrile by five days after fever first develops.
Secondary Outcomes
No secondary outcomes reported
Investigators
Robert Betts
Principal Investigator
University of Rochester