Daptomycin Versus Placebo in Patients With Neutropenia and Fever

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Single Center, Double-Blind, Randomized, Comparative Study to Evaluate the Efficacy and Safety of Daptomycin Versus Placebo in Patients With Neutropenia and Fever.

Conditions
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Febrile Neutropenia

Intervention / Treatment
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* Drug: Daptomycin
* Other: Saline Placebo
* Drug: Daptomycin


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Daptomycin<br>Daptomycin intravenous 8mg/kg once per day 5-10 days. | Drug: Daptomycin<br>* 8 MG/KG IV<br>* Other names: Cubicin;Drug: Daptomycin<br>* 8 mg/kg once daily<br>* Other names: Cubicin;|
| Placebo Comparator: Saline Placebo<br>Saline solution | Other: Saline Placebo<br>* 50 ml normal saline once daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Afebrile Neutropenic Subjects | To determine whether the percentage of neutropenic subjects that become afebrile by five days after fever first develops. | 5 days |