Daptomycin Versus Placebo in Patients With Neutropenia and Fever

Phase 3

Terminated

• Conditions: Febrile Neutropenia
• Interventions: Other: Saline Placebo; Drug: Daptomycin

• Registration Number: NCT01216241
• Lead Sponsor: University of Rochester

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 Timeline

• Study First Submitted: 2010-10-04
• Study First Submitted QC: 2010-10-06
• Study First Posted: 2010-10-07
• Study Start: 2011-04
• Primary Completion: 2013-04
• Study Completion: 2013-04
• Results First Submitted: 2013-11-06
• Status Verified: 2014-03
• Results First Submitted QC: 2014-03-04
• Last Update Submitted: 2014-03-04
• Results First Posted: 2014-04-10
• Last Update Posted: 2014-04-10

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

1. Patients in the above categories who are currently undergoing chemotherapy.
2. Patients at least 18 of age.
3. Patient expected to reach an absolute granulocyte count of <100 cells/mm3
4. 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

1. 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.
2. Patients undergoing auto-transplantation, for the same reason as above.
3. 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.
4. Patients who have received daptomycin in the two weeks prior to enrollment.
5. Patients with concomitant use of vancomycin.
6. Patients with creatinine clearance < 30 ml/min or CPK > 3x normal
7. Patients with significant hepatic dysfunction, defined as baseline liver function tests > 5x above normal.
8. Patients with known allergy to daptomycin.
9. Patients previously in this study.
10. Women of child bearing age who are either lactating or pregnant (as evidenced by a positive urine pregnancy test or positive serum beta-HCG).
11. Patients previously enrolled in this study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Saline Placebo	Saline Placebo	Saline solution
Daptomycin	Daptomycin	Daptomycin intravenous 8mg/kg once per day 5-10 days.

Primary Outcome Measures

Name	Time	Method
Percentage of Afebrile Neutropenic Subjects	5 days	To determine whether the percentage of neutropenic subjects that become afebrile by five days after fever first develops.

Trial Locations

Locations (1)

University of Rochester Medical Center; 🇺🇸 Rochester, New York, United States