Daptomycin Versus Placebo in Patients With Neutropenia and Fever

Febrile Neutropenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01216241
• Other study ID #: DAPNEUT
• Status: Terminated
• Phase: Phase 3
• First received: October 4, 2010
• Last updated: March 4, 2014
• Start date: April 2011
• Est. completion date: April 2013

Study information

• Verified date: March 2014
• Source: University of Rochester
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 36
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Febrile Neutropenia
• Neutropenia

Intervention

Drug:
• Daptomycin
8 MG/KG IV

Other:
• Saline Placebo
50 ml normal saline once daily

Drug:
• Daptomycin
8 mg/kg once daily

Locations

Country	Name	City	State
United States	University of Rochester Medical Center	Rochester	New York

Sponsors (2)

Lead Sponsor	Collaborator
University of Rochester	Cubist Pharmaceuticals LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes