Staphylococcal InfectionsPhase 3NCT00217841
Aurograb and Vancomycin in MRSA Infection
A Phase 3 study testing Aurograb in people with Staphylococcal Infections, run by NeuTec Pharma at 1 site in United Kingdom.
Trial summary
The study hypothesis is that the addition of Aurograb to standard vancomycin therapy will improve outcome in MRSA infection. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Staphylococcal Infections
- What is being tested?
- Aurograb
- How many people
- 180 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2004to Mar 2006
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this 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
The study hypothesis is that the addition of Aurograb to standard vancomycin therapy will improve outcome in MRSA infection.
Read the 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:
- 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.
- 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.
- To extend the data base on pharmacokinetics.
- Conditions
- Staphylococcal Infections
- Being tested
- Aurograb
- Keywords
- MRSA
- Medical subject headings
- Staphylococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AurograbDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Secondary outcomes (6)
attributable mortality
overall mortality
clinical response
bacterial response
rates of clinical resistance to vancomycin.
To extend the data base on pharmacokinetics.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startJan 2004
- Study completionMar 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Staphylococcal InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Early clinical test
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 180 participants
Sponsor and investigators
- Lead sponsor
- NeuTec Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Mark H Wilcox, MD, Principal investigator, Leeds Teaching Hospitals NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00217841
- Sponsor's protocol ID
- NTP/Aurograb/003
- Status last verified
- Sep 2006
- First submitted
- 14 Sep 2005
- Last updated
- 19 Sep 2006
- Results posted
- No
Publications
Burnie JP, Matthews RC, Carter T, Beaulieu E, Donohoe M, Chapman C, Williamson P, Hodgetts SJ. Identification of an immunodominant ABC transporter in methicillin-resistant Staphylococcus aureus infections. Infect Immun. 2000 Jun;68(6):3200-9. doi: 10.1128/IAI.68.6.3200-3209.2000.
PubMed 10816464
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00217841
- Acronym / sponsor ID
- NTP/Aurograb/003
- Conditions
- Staphylococcal Infections
- Keywords
- MRSA
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants
- Lead sponsor
- NeuTec PharmaIndustry (pharma, biotech, devices)
- Study start
- Jan 2004
- Study completion
- Mar 2006
- First posted
- 22 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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.
- To extend the data base on pharmacokinetics.
Study design
- Primary purpose
- Early clinical test
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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:
- 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.
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aurograb | Drug | – |
Primary outcome
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.
6 secondary outcomes
attributable mortality
overall mortality
clinical response
bacterial response
rates of clinical resistance to vancomycin.
To extend the data base on pharmacokinetics.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2006.
- Background: PubMed 10816464Burnie JP, Matthews RC, Carter T, Beaulieu E, Donohoe M, Chapman C, Williamson P, Hodgetts SJ. Identification of an immunodominant ABC transporter in methicillin-resistant Staphylococcus aureus infections. Infect Immun. 2000 Jun;68(6):3200-9. doi: 10.1128/IAI.68.6.3200-3209.2000.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark H Wilcox, MD principal investigator
Leeds Teaching Hospitals NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Aurograb in people with Staphylococcal Infections, run by NeuTec Pharma at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00217841, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2006.