The aim of the CF START trial is determine the safest and most effective way to treat infants diagnosed with Cystic Fibrosis (CF) with antibiotics. At the moment infants in the UK are prescribed an antibiotic, usually flucloxacillin, every day to prevent infection with a bacteria (bug) called Staphylococcus aureus (SA).
Although this approach appears to help prevent SA infection, there is a worry that it may make earlier infection with other bugs, such as Pseudomonas aeruginosa (PsA) more likely.
This trial is designed to test if infants with CF are more likely to get an earlier infection from PsA if they are taking flucloxacillin on a daily basis (“Prevent and Treat”) or Antibiotics in a more targeted manner (“Detect and Treat”).
This study has been funded by the National Institute for Health Research's Health Technology Assessment (HTA) Programme (ref: 14/22/23).
Alder Hey Childrens Hospital Foundation Trust.
The study has been reviewed by a research ethics committee, who have agreed the study is being conducted in a correct and appropriate manner. The study has also been approved by the Medicines & Healthcare products Regulatory Agency (MHRA).
Why are we doing this research?
The first infection caused by PsA has proved to be an important moment for those affected by CF, because of the increased treatment requirements.
It is therefore important to find out whether “Prevent and Treat” or “Detect and Treat” leads to earlier PsA airway infection.
This study aims to provide confidence to hospitals and participants that the current way of treating CF infants (“Prevent and Treat”), does not make earlier airway infection by PsA more likely. We will need 480 infants to take part in CF START to make it successful.
What will we have to do if we take part?
A member of your baby’s clinical team will talk to you first in more detail and you will be able to ask any questions that you may have. If you have had all of your questions answered and are happy to take part then you will be asked to sign a consent form. You will be given a copy of the consent form and this information sheet to keep.
We will follow up your baby for 4 years and information on your baby’s progress will be recorded on the UK CF Registry. You will not be required to attend any extra visits to the hospital aside from those you would normally make.
How will I know which treatment I’m going to have?
In research studies we often split participants up into groups to look at how different treatments work.
participants in one group get a different treatment than participants in another group.
In CF START there are two treatment groups:
It is really important that each group in CF START has a similar mix of participants in it. Having a similar mix means that we know that if one group of participants does better than the other, it is very likely to be because of the treatment and not because there are differences in the types of participants in each group.
We use a computer programme that puts participants ‘at random’ into one of the groups – you might hear this described as ‘randomisation’ or ‘random allocation’, but they all mean the same thing. Using randomisation means that participants get mixed into each group, reducing the chance that one group has a different type of patient to another.
In CF START you are equally as likely to be in the “Prevent and Treat” group as you are to be in the “Detect and Treat” group. You and the clinical team will not be able to choose which treatment arm your baby will receive. Your healthcare team will let you know which group you are in as soon as possible.
Will my baby’s participation be kept confidential?
Yes, only people working on the study, or working to ensure the study is run correctly will have access to your data. All information collected about you during this study and any future follow up will be confidential, and will be handled, stored and destroyed in accordance with the Data Protection Act 1998.
We will also let the GP, who your baby will be registered with, know that your baby is participating in CF START.
Who has reviewed the study?
Research on licenced drugs, like flucloxacillin, is reviewed by an authority called the Medicines and Healthcare products Regulatory Agency (MHRA). If the MHRA believe it is safe then they will approve the study. This study has been approved by the MHRA.
What are the benefits and risks of taking part?
At present, the normal practice in preventing growth of SA is to take antibiotics in a “Prevent and Treat” manner. However it is not known if this results in earlier infection by PsA. Infants randomised to “Detect and Treat” may receive less antibiotics than they would under standard care. However this may result in earlier infection of SA.
The result of the study will be of benefit to participants with CF, and contribute to a better understanding of the effect of taking flucloxacillin in a “Prevent and Treat” manner, all of which may lead to benefits for your baby and others with CF.
In addition, there will always be a member of the research team that you can phone if you are concerned about anything or for advice.
No additional procedures will be involved over and above normal clinical care unless you choose to be involved in the additional assessment.
The Chief Investigator
Please feel free to contact the CF START study team by any of the means below: