Daptomycin Versus Placebo in Patients With Neutropenia and Fever

March 4, 2014 updated by: Robert Betts, University of Rochester

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

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

36

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Rochester, New York, United States, 14642
        • University of Rochester Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Daptomycin
Daptomycin intravenous 8mg/kg once per day 5-10 days.
Drug: Daptomycin
8 MG/KG IV
Other Names:
  • Cubicin
Drug: Daptomycin
8 mg/kg once daily
Other Names:
  • Cubicin
PLACEBO_COMPARATOR: Saline Placebo
Saline solution
Other: Saline Placebo
50 ml normal saline once daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Afebrile Neutropenic Subjects
Time Frame: 5 days
To determine whether the percentage of neutropenic subjects that become afebrile by five days after fever first develops.
5 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Rochester

Collaborators

Cubist Pharmaceuticals LLC

Investigators

  • Principal Investigator: Robert F Betts, MD, University of Rochester

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2011

Primary Completion (ACTUAL)

April 1, 2013

Study Completion (ACTUAL)

April 1, 2013

Study Registration Dates

First Submitted

October 4, 2010

First Submitted That Met QC Criteria

October 6, 2010

First Posted (ESTIMATE)

October 7, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

April 10, 2014

Last Update Submitted That Met QC Criteria

March 4, 2014

Last Verified

March 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DAPNEUT

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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