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| Sponsored by: |
NeuTec Pharma |
|---|---|
| Information provided by: | NeuTec Pharma |
| ClinicalTrials.gov Identifier: | NCT00217841 |
Purpose
The study hypothesis is that the addition of Aurograb to standard vancomycin therapy will improve outcome in MRSA infection.
| Condition | Intervention | Phase |
|---|---|---|
|
Staphylococcal Infections |
Drug: Aurograb |
Phase III |
| Study Type: | Interventional |
| Study Design: | Educational/Counseling/Training, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| 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 |
| Estimated Enrollment: | 180 |
| Study Start Date: | January 2004 |
| Estimated Study Completion Date: | March 2006 |
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:
To further determine efficacy, comparing Aurograb versus placebo, regarding:
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
All patients will have to satisfy the following inclusion criteria to enter the study:
Exclusion Criteria:
Patients fulfilling the following criteria will not enter the study:
Contacts and Locations
More Information
| Study ID Numbers: | NTP/Aurograb/003 |
| Study First Received: | September 14, 2005 |
| Last Updated: | September 18, 2006 |
| ClinicalTrials.gov Identifier: | NCT00217841 History of Changes |
| Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency |
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MRSA |
|
Bacterial Infections Anti-Bacterial Agents Staphylococcal Infections Gram-Positive Bacterial Infections Vancomycin |
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Bacterial Infections Anti-Infective Agents Anti-Bacterial Agents Staphylococcal Infections Communicable Diseases |
Gram-Positive Bacterial Infections Therapeutic Uses Vancomycin Infection Pharmacologic Actions |