MRC Clinical Trials Unit at UCL
90 High Holborn
What is this study about?
Staphylococcus aureus (or S. aureus) is a bug which can cause serious infections, including infections of the blood. Doctors use an antibiotic to cure S. aureus but sometimes the infection comes back and sometimes the antibiotic does not succeed.
We want to find out whether or not giving an extra antibiotic, called rifampicin, in addition to the standard antibiotic treatment, will help sick people with S. aureus blood infections.
Rifampicin is not a new antibiotic. It has been used by doctors for more than 30 years to treat a variety of infections. But we want to know if giving rifampicin as well as the usual antibiotic can cure more people, possibly faster, with S. aureus infections; or whether it makes no difference to how well people do, and the standard antibiotic on its own is good enough. We also want to know if it gives more side-effects, or encourages the bug to become resistant to the antibiotics and so not work so well in the future.
At the moment we do not know whether taking rifampicin as an extra antibiotic helps people with S. aureus blood infections and this is the reason for doing the study.
Who can join the trial?
To join ARREST participants will be in hospital and have a blood infection which the doctor thinks is caused by S. aureus.
Who decides about taking part in the study?
Most patients with Staph aureus blood infection are well enough to make their own decision about joining the study. However sometimes patients are very sick and unable to decide for themselves about joining a study like ARREST.
In this case, someone who knows them well is asked to make a decision for them. This person is known as a “personal legal representative”. They would be someone the patient would trust to make important decisions about their well being and what they would want to happen. If a legal representative agrees a patient can join the study, when the patient gets better they can make their own decision about staying in the study, or leaving it.
If for some reason a “personal legal representative” cannot be found then one of the senior hospital doctors may be asked to make this decision. This doctor will have no interest in the study and so will only make the decision based on his/her clinical judgement.
What will being in the study involve?
Patients will get the same standard antibiotic whether or not they join the study and this would be determined by the doctors treating them. Being in the study means they would get extra drugs, EITHER rifampicin OR a “placebo” for two weeks. But everyone will receive the standard antibiotic that would normally be prescribed for this type of infection.
A “placebo” is a dummy treatment. Half the patients in ARREST get rifampicin and half get a “placebo”. The two groups of patients are similar in everything apart from rifampicin or “placebo”. This means we can compare them to work out whether or not rifampicin is helpful. Neither the patient nor the doctor will know which treatment the patient is getting because they will look the same. However, if the doctor needs to find out he/she can do so.
A study doctor or nurse comes to see patients in the ARREST study regularly whilst they are in hospital. They will take a small amount of extra blood for extra tests to look at how rifampicin might be helping patients, and for side-effects. Three months after joining the study, patients will come back to clinic for a final study check up visit to make sure everything is okay. Patients should continue to see their GP and attend other non-study hospital visits as needed.
When is it taking place?
ARREST opened to recruitment in November 2012. Participants are followed up for 12 weeks. It is anticipated the trial will be completed in approximately 4 years
Where is it taking place?
ARREST is taking place in hospitals in the UK.