Daptomycin Versus Placebo in Patients With Neutropenia and Fever

This study has been terminated.
(The study has shown futility and the objectives could not be reached without enrolling a very large number of subjects.)
Sponsor:
Collaborator:
Cubist Pharmaceuticals
Information provided by (Responsible Party):
Robert Betts, University of Rochester
ClinicalTrials.gov Identifier:
NCT01216241
First received: October 4, 2010
Last updated: March 4, 2014
Last verified: March 2014
  Purpose

The purpose of this study is to evaluate the benefits and side effects of daptomycin compared to placebo for the treatment of neutropenic fever.


Condition Intervention Phase
Febrile Neutropenia
Drug: Daptomycin
Other: Saline Placebo
Phase 3

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

Resource links provided by NLM:


Further study details as provided by University of Rochester:

Primary Outcome Measures:
  • Percentage of Afebrile Neutropenic Subjects [ Time Frame: 5 days ] [ Designated as safety issue: Yes ]
    To determine whether the percentage of neutropenic subjects that become afebrile by five days after fever first develops.


Enrollment: 36
Study Start Date: April 2011
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Daptomycin
Daptomycin intravenous 8mg/kg once per day 5-10 days.
Drug: Daptomycin
8 MG/KG IV
Other Name: Cubicin
Drug: Daptomycin
8 mg/kg once daily
Other Name: Cubicin
Placebo Comparator: Saline Placebo
Saline solution
Other: Saline Placebo
50 ml normal saline once daily

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01216241

Locations
United States, New York
University of Rochester Medical Center
Rochester, New York, United States, 14642
Sponsors and Collaborators
University of Rochester
Cubist Pharmaceuticals
Investigators
Principal Investigator: Robert F Betts, MD University of Rochester
  More Information

No publications provided

Responsible Party: Robert Betts, Principal Investigator, University of Rochester
ClinicalTrials.gov Identifier: NCT01216241     History of Changes
Other Study ID Numbers: DAPNEUT
Study First Received: October 4, 2010
Results First Received: November 6, 2013
Last Updated: March 4, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Neutropenia
Agranulocytosis
Leukopenia
Leukocyte Disorders
Hematologic Diseases
Daptomycin
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 22, 2014