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Treatment Algorithm to Reduce the Use of Vancomycin in Adults With Blood Stream Infection — Bacteremia  

Bacteremia Clinical Trial

Official title:
A Multi-Center, Randomized, Open-Label, Comparative Study to Assess the Safety and Efficacy of a Treatment Algorithm to Reduce the Use of Vancomycin in Adult Patients With Blood Stream Infections Due to Staphylococci

Clinical Trial Summary

The purpose of this study is to accurately determine the length of appropriate drug treatment for staphylococcal blood stream infection. The study seeks to address important information about the management of staphylococcal blood stream infections.

Clinical Trial Description

To demonstrate that the clinical efficacy of algorithm-based therapy of patients with staphylococcal blood stream infection is noninferior to current standard of care.

PP (per protocol) population: randomized patients EXCLUDING those that: Received a PENS antibiotic -Did not undergo removal of intravascular catheter suspected to be infected. Note that patients with simple CoNS bacteremia may retain the catheter; all other patients should have their catheter(s) removed. -Had blood stream infection with a vancomycin-resistant staphylococcus; or a staphylococcus resistant to protocol-identified alternative drugs if these were used -Discontinued study medication prematurely for reasons other than clinical failure -Did not undergo final TOC assessment -Did not comply with all Patient Inclusion Criteria -Violated any Patient Exclusion Criteria

- Died within 3 days of randomization

- Were classified as non-evaluable

PPE Population: Patients from the PP population who did not have complicated staphylococcal infection. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01191840
Study type Interventional
Source Duke University
Contact
Status Completed
Phase Phase 2
Start date February 2011
Completion date March 4, 2017
View Details
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