Aurograb and Vancomycin in MRSA Infection (NCT00217841) | Clinical Trial Compass
CompletedPhase 3
Aurograb and Vancomycin in MRSA Infection
United Kingdom180 participantsStarted 2004-01
Plain-language summary
The study hypothesis is that the addition of Aurograb to standard vancomycin therapy will improve outcome in MRSA infection.
Who can participate
Age range18 Years – 80 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
All patients will have to satisfy the following inclusion criteria to enter the study:
* 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 administrati…
What they're measuring
1
The response to Aurograb® (1mg/kg i.v. b.d.) plus vancomycin is greater than the overall response to placebo plus vancomycin,in patients with severe, deep-seated staphylococcal infections.