Daptomycin Versus Placebo in Patients With Neutropenia and Fever

NCT01216241 | Terminated Phase 3 Results DMC

• 1 other identifier: DAPNEUT
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Febrile Neutropenia

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Daptomycin

ACTIVE COMPARATOR

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

Drug: Daptomycin

Saline Placebo

PLACEBO COMPARATOR

Saline solution

Other: Saline Placebo

Interventions

Daptomycin DRUG

8 MG/KG IV

Also known as: Cubicin

Daptomycin

Saline Placebo OTHER

50 ml normal saline once daily

Saline Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Rochester: lead
• Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA): collaborator

Study Sites (1)

University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

MeSH Terms

Conditions

Febrile Neutropenia

Interventions

Daptomycin

Condition Hierarchy (Ancestors)

Neutropenia; Agranulocytosis; Leukopenia; Cytopenia; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukocyte Disorders

Intervention Hierarchy (Ancestors)

Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Lipopeptides; Lipids; Peptides; Amino Acids, Peptides, and Proteins

Limitations and Caveats

It was felt that this study had shown futility and objectives could not be reached without enrolling a very large number of subjects in a reasonable time frame.

Results Point of Contact

• Title: Dr. Robert F. Betts
• Organization: University of Rochester

robert_betts@urmc.rochester.edu

585-275-5871

Study Officials

• Robert F Betts, MD

  University of Rochester

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 4, 2010
• First Posted: October 7, 2010
• Study Start: April 1, 2011
• Primary Completion: April 1, 2013
• Study Completion: April 1, 2013
• Last Updated: April 10, 2014
• Results First Posted: April 10, 2014

Record last verified: 2014-03

Locations

US (1)