Daptomycin Versus Placebo in Patients With Neutropenia and Fever

NCT ID: NCT01216241

Last Updated: 2014-04-10

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-04-30
• Study Completion Date: 2013-04-30

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.

Conditions

Febrile Neutropenia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Daptomycin

Daptomycin intravenous 8mg/kg once per day 5-10 days.

Group Type: ACTIVE_COMPARATOR

Daptomycin

Intervention Type: DRUG

8 MG/KG IV

Daptomycin

Intervention Type: DRUG

8 mg/kg once daily

Saline Placebo

Saline solution

Group Type: PLACEBO_COMPARATOR

Saline Placebo

Intervention Type: OTHER

50 ml normal saline once daily

Interventions

Daptomycin

8 MG/KG IV

Intervention Type: DRUG

Saline Placebo

50 ml normal saline once daily

Intervention Type: OTHER

Daptomycin

8 mg/kg once daily

Intervention Type: DRUG

Other Intervention Names

Cubicin; Cubicin

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

INDUSTRY

Sponsor Role: collaborator

University of Rochester

OTHER

Sponsor Role: lead

Responsible Party

Robert Betts

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Robert F Betts, MD

Role: PRINCIPAL_INVESTIGATOR

University of Rochester

Locations

University of Rochester Medical Center

Rochester, New York, United States

Countries

United States

Other Identifiers

DAPNEUT

Identifier Type: -

Identifier Source: org_study_id