STOP 360: A trial comparing the use of different antibiotic treatments for CF lung flare-ups

A study to look at standardising intravenous antibiotic treatment for lung exacerbations in people with Cystic Fibrosis (CF)

This study will compare different intravenous (IV) antibiotic treatments for lung exacerbations in adults with CF. The results will help guide future treatment for lung exacerbations.

The study will include people experiencing lung exacerbations (a worsening of chest symptoms such as coughing and wheezing) that leads to treatment with IV antibiotics (germ-fighting medicines). It will compare treatment with one antibiotic (a beta-lactam such as cefepime or ceftazidime) to treatment with two antibiotics (tobramycin and a beta-lactam) to learn whether there is a difference in lung function and symptom improvement between the two groups.

What the study involves:
Participants will be given IV antibiotic treatment for around 12 to 16 days to treat their lung exacerbation. A computer will randomly assign participants to receive either one or two antibiotics Participants will be able to carry out IV treatment at home or in hospital and will be asked to provide three blood samples while taking IV antibiotics to monitor liver and kidney function.

Participants will be asked to attend two in-person visits and one follow-up phone call. Each in person visit will take 2 to 3 hours, and the phone call will take about 30 minutes. During in-person visits participants will be asked to answer questions about their health, have a physical exam, and perform a lung function test.