Ignite Creation Date:
2024-05-05 @ 12:01 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00217841
Status:
COMPLETED
Last Update Posted:
2006-09-19
First Post:
2005-09-14
Brief Title:
Aurograb and Vancomycin in MRSA Infection
Sponsor:
NeuTec Pharma
Organization:
NeuTec Pharma
Study Overview
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
Status Verified Date:
2006-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The study hypothesis is that the addition of Aurograb to standard vancomycin therapy will improve outcome in MRSA infection
Detailed Description:
The Primary Objective will be to determine whether the overall response clinical and bacterial to Aurograb 1mgkg iv bd 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 1mgkg bd plus vancomycin versus placebo plus vancomycin in adult hospitalised patients with deep-seated staphylococcal infections
3 To extend the data base on pharmacokinetics
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 1mgkg bd plus vancomycin versus placebo plus vancomycin in adult hospitalised patients with deep-seated staphylococcal infections
3 To extend the data base on pharmacokinetics
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None