NCT01191840

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 509 (actual)
• Sponsor: Duke University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Bacteremia

Interventions

Type	Name	Description
DRUG	Vancomycin	Duration
DRUG	Vancomycin	Duration

Timeline

• Start date: 2011-02-01
• Primary completion: 2017-03-04
• Completion: 2017-03-04
• First posted: 2010-08-31
• Last updated: 2018-01-05
• Results posted: 2017-12-12

Locations

15 sites across 2 countries: United States, Spain