Aurograb and Vancomycin in MRSA Infection

Staphylococcal Infections Clinical Trial

Official title: A Multi Centre, Double-Blind, Randomised, Placebo Controlled Prospective Study on the Safety and Efficacy of Aurograb in Patients With Severe, Deep-Seated Staphylococcal Infections Receiving Vancomycin

Status Completed

Clinical Trial Summary

The study hypothesis is that the addition of Aurograb to standard vancomycin therapy will improve outcome in MRSA infection.

Clinical Trial Description

The Primary Objective will be to determine whether the overall response (clinical and bacterial) to Aurograb® (1mg/kg i.v. b.d.) plus vancomycin is greater than the overall response to placebo plus vancomycin, in adult hospitalised patients with severe, deep-seated staphylococcal infections, particularly MRSA infections, being treated with vancomycin.

Secondary Objectives will be:

1. To further determine efficacy, comparing Aurograb versus placebo, regarding:

• attributable mortality

• overall mortality

• clinical response

• bacterial response ie eradication or persistence of the infection

• rates of clinical resistance to vancomycin.

2. To compare the safety profile of treatment with Aurograb® (1mg/kg b.d.) plus vancomycin versus placebo plus vancomycin in adult hospitalised patients with deep-seated staphylococcal infections.

3. To extend the data base on pharmacokinetics. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Educational/Counseling/Training

Related Conditions & MeSH terms

• Infection
• Staphylococcal Infections

• NCT number: NCT00217841
• Study type: Interventional
• Source: NeuTec Pharma
• Status: Completed
• Phase: Phase 3
• Start date: January 2004
• Completion date: March 2006