CompletedInterventional

CF START: A national UK trial to determine whether taking an antibiotic (flucloxacillin) every day predisposes infants with cystic fibrosis (CF) to earlier infection with a bug, Pseudomonas aeruginosa, that is resistant to treatment

Cystic fibrosis is a genetic condition that causes thick, sticky mucus to build up in the lungs and tummy, making chest infections more likely. Doctors in the UK often give babies a daily antibiotic called flucloxacillin to stop a common bug called Staphylococcus aureus. However, experts want to know if daily antibiotics might make it easier for a tougher bug, called Pseudomonas aeruginosa, to take hold. The CF START trial compares two approaches in newborn babies up to 48 months of age. One group takes daily liquid flucloxacillin to prevent infections. The other group only takes antibiotics when they become unwell or when lab tests show bugs are present. By tracking both groups, researchers hope to discover the safest, most effective antibiotic plan for infants growing up with cystic fibrosis across the UK.

At a glance

Status

Completed

Sponsor

Alder Hey Children's NHS Foundation Trust

Enrolment target

480

Start

01 Nov 2016

Estimated completion

04 May 2023

Cystic fibrosis

What is this study about?

Cystic fibrosis (CF) is an inherited condition that affects how salt and water move in and out of cells. This causes thick, sticky mucus to build up in the lungs and digestive system. Because mucus can trap germs, babies with CF are at a higher risk of developing chest infections. To protect their lungs, doctors usually give antibiotics to prevent or treat these bugs before they cause lasting harm.

For many years, the standard approach in the UK has been to give babies a daily dose of an antibiotic called flucloxacillin. This medicine works well to protect against a common germ called Staphylococcus aureus. However, doctors are concerned that taking antibiotics every day might clear the way for a different, harder-to-treat germ called Pseudomonas aeruginosa to move in earlier in childhood.

CF START is a UK-wide study designed to find the safest long-term answer. It compares giving daily preventative flucloxacillin against a targeted approach, where antibiotics are only used if tests show a bug or if the baby develops symptoms. Both methods are already used in different parts of the world, but this study will show which strategy gives babies the best protection as they grow.

Key takeaways

CF START is a UK clinical trial looking at antibiotic strategies for babies with cystic fibrosis.
It compares taking daily preventative flucloxacillin with only taking antibiotics when symptoms or bugs appear.
The study aims to see which strategy best prevents early infection with the hard-to-treat bug Pseudomonas.
Babies join before they are 90 days old and are followed up until their fourth birthday.
Both treatment approaches are safe and supported by cystic fibrosis specialists.

Who may be eligible?

This trial is for newborn babies who have been diagnosed with cystic fibrosis and are 90 days old or younger. Their parents or guardians must give consent for them to join both the CF START study and the national UK Cystic Fibrosis Registry.

Babies cannot take part if they have already had an infection with the Pseudomonas bug, or if their newborn screening results were inconclusive. Infants who have had allergic reactions to penicillin-type medicines or who have had liver problems linked to flucloxacillin are also unable to join.

Finally, babies with other major health conditions that could interfere with their CF care cannot take part. Your baby's cystic fibrosis care team will look at their test results to confirm whether this trial is suitable.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

My baby has a confirmed diagnosis of cystic fibrosis.
My baby is 90 days old or younger.
My baby has never had an infection with Pseudomonas aeruginosa.
My baby is not allergic to penicillin or flucloxacillin.
We are willing to take part and join the UK Cystic Fibrosis Registry.

Answer every question to see your result.

What does participation involve?

If your baby joins the study, a computer will randomly place them into one of two groups. You and your doctor cannot choose the group, ensuring the study results are fair and reliable.

Babies in the first group take flucloxacillin liquid twice a day at home as a preventative treatment until they turn four years old. Babies in the second group do not take daily preventative antibiotics. Instead, they are given specific antibiotics only when routine clinic swabs find a germ, if they develop symptoms, or if they need a general anaesthetic for an operation.

Taking part will not add many extra hospital trips. Your baby will be monitored during their regular cystic fibrosis clinic visits until their fourth birthday. The care team will take standard throat swabs and check your baby's growth and chest health at each visit.

Potential risks and benefits

Taking part helps doctors understand the safest way to care for babies with cystic fibrosis in the future. Both treatment strategies are considered safe, standard medical approaches, and your baby will be closely watched by their CF team whichever group they are in. Flucloxacillin is a well-known medicine, but like all antibiotics, it can sometimes cause mild tummy upset or loose stools. Joining the study is completely voluntary, and you can withdraw your baby at any time without their normal NHS care being affected.

Locations (1)

Alder Hey Children’s Hospital
Approximate
Liverpool, England

Common questions

What is flucloxacillin?

Flucloxacillin is a common penicillin-type antibiotic that doctors frequently prescribe to treat or prevent skin and chest infections caused by staphylococcal bacteria.

Why can't I choose which group my baby joins?

The study uses a computer to assign babies randomly. This makes sure both groups are as similar as possible so the results are scientifically fair and accurate.

Will my baby still get antibiotics if they get sick in the targeted group?

Yes. If your baby develops any symptoms or if regular swab tests find a bug, their doctor will promptly prescribe the right antibiotics to treat them.

How long does the study last?

Your baby will be followed until they reach four years of age (48 months), mainly during their normal cystic fibrosis clinic appointments.

Can we change our minds after starting?

Yes. You can leave the study at any time without giving a reason, and your baby will continue to receive the full support of their cystic fibrosis team.

How to find out more

Claire Soady

cfstart@liverpool.ac.uk +44 (0)151 794 9764 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.