Clinical Trial: Daptomycin Versus Placebo in Patients With Neutropenia and Fever

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

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.

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 Summary: 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.
Sponsor: University of Rochester

Current Primary Outcome: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: University of Rochester

Dates:
Date Received: October 4, 2010
Date Started: April 2011
Date Completion:
Last Updated: March 4, 2014
Last Verified: March 2014