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COMPLETEDPHASE3

Aurograb and Vancomycin in MRSA Infection

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

NCT00217841•NeuTec Pharma

View on ClinicalTrials.gov

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® (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.

Eligibility

Age

18 - 80 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Hospitalised adult patients (18 years or over) with severe, deep-seated staphylococcal infection being treated with vancomycin, this diagnosis being based on clinical signs and symptoms appropriate to the site of infection (as detailed under subsets, Section 4.6) plus a positive culture or Gram stain showing Gram positive cocci in clusters (not chains) from one or more of the following clinically significant sites:
•i. a blood culture ii. a lower respiratory tract specimen eg sputum or BAL iii. pleural fluid iv. intra-abdominal fluid or tissue v. urine (in patients with renal sepsis or complicated urinary tract infections)
•The study drug must be started while there is clinical evidence of active infection (usually within 24 hours of starting vancomycin, although longer delays are acceptable if the patient is still clinically septic and culture positive within 24 hours of starting study drug).
•Recruitment may be initiated on the basis of a Gram stain but, for the patient to be eligible to continue in the study, staphylococcal sepsis must subsequently be confirmed by culture.
•The positive specimen must be from a clinically significant specimen taken within 2 days of starting the study drug.
•Patients must be on i.v. vancomycin as the sole systemic antibiotic for the first 3 days of the study.
•Patients must have sufficient venous access to permit administration of study drug and monitoring of safety variables
•Written informed consent must be obtained for participation in the study.

Exclusion Criteria

•Patients fulfilling the following criteria will not enter the study:
•Prior Antibiotic Usage: Patients who have received (within 48 hours of study entry) a systemic anti-staphylococcal antibiotic other than vancomycin for longer than 24 hours, unless the patient was considered to have failed that regime ie a documented treatment failure (ie 3 days' treatment and not responding) or the Staphylococcus is resistant to the antibiotic in vitro (e.g. the patient is initially treated with flucloxacillin but the isolate subsequently identified as resistant) - in such cases the antibiotic must be changed to vancomycin to enter the study.
•Concomitant Antibiotics: usage of concomitant antibiotic except as allowed by the protocol (see Section 5.3)
•Patients with devices infected with S. aureus, including implants and catheters, which cannot be removed
•Patients known to have AIDS, who have a CD4 cell count \< 200 cells/mm3
•Patients with staphylococcal endocarditis, mediastinitis, meningitis, osteomyelitis and/or joint infections.
•Asymptomatic carriers of MRSA - such patients must be clinically septic due to the MRSA
•Patients with methicillin-sensitive CNS (MSSE)
•Patients with methicillin-resistant CNS (MRSE) unless they are clinically significant blood culture isolates, as indicated by two blood cultures (taken from two different sites) growing the same CNS in a clinically septic patient in whom there is no other significant pathogen responsible for the sepsis
•Females who have a positive pregnancy test
+4 more criteria

Locations (1)

Mark Wilcox

Leeds, England, United Kingdom

Key Dates

Start Date

January 1, 2004

Completion Date

March 1, 2006

Last Updated

September 19, 2006

Enrollment

180

Estimated participants

Conditions

Staphylococcal Infections

Interventions

Aurograb

DRUG

Unbound Cloxacillin Concentrations During Continuous Infusion

NCT06848387

Staphylococcal Infections

View study

RECRUITINGPHASE4

Adjunctive Clindamycin for the Treatment of Skin and Soft Tissue Infections, a Randomized Controlled Trial

NCT05899140

Skin InfectionStaphylococcal Infections+1 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 19, 2006Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Aurograb and Vancomycin in MRSA Infection

Inclusion Criteria

Exclusion Criteria

Unbound Cloxacillin Concentrations During Continuous Infusion

Adjunctive Clindamycin for the Treatment of Skin and Soft Tissue Infections, a Randomized Controlled Trial

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