NCT01216241

Daptomycin Versus Placebo in Patients With Neutropenia and Fever

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

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: University of Rochester · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	Daptomycin	8 MG/KG IV
OTHER	Saline Placebo	50 ml normal saline once daily
DRUG	Daptomycin	8 mg/kg once daily

Timeline

• Start date: 2011-04-01
• Primary completion: 2013-04-01
• Completion: 2013-04-01
• First posted: 2010-10-07
• Last updated: 2014-04-10
• Results posted: 2014-04-10

Locations

1 site across 1 country: United States