Overview

Aurograb and Vancomycin in MRSA Infection

Status:
Completed
Trial end date:
2006-03-01
Target enrollment:
0
Participant gender:
All
Summary
The study hypothesis is that the addition of Aurograb to standard vancomycin therapy will improve outcome in MRSA infection.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
NeuTec Pharma
Treatments:
Vancomycin
Criteria
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 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

- Patients who have a known allergy to any constituent of Aurograb® (i.e.
hypersensitivity to antibody, nickel, urea or arginine)

- Patients who have received an unlicensed drug within three months prior to the study

- Patients with a concomitant medical condition, in whom, in the opinion of the
Investigator, participation may create an unacceptable risk for the patient

- Patients considered inappropriate for enrolment in this study by the Investigator for
any other reason.