Therapeutic approach
The type of treatment or therapy being studied. A therapy could range from a medication addressing a particular characteristic of CF to a device or activity e.g. exercise
Trial of Optimal Therapy for Pseudomonas Eradication in Cystic Fibrosis
Study details
This study is a two arm, multicentre parallel group, randomised controlled trial comparing ten days of intravenous therapy to three months of oral therapy in Cystic Fibrosis patients whose lungs have become infected with a bacterium called Pseudomonas(P. aeruginosa). 280 patients (children and adults)in total will be randomised, 140 in each arm of the trial.
Background and study aims:
Cystic fibrosis (CF) is a genetic condition in which the lungs and digestive system become clogged with thick sticky mucus. CF patients are at risk of developing infection in their lungs which can cause health problems. A common cause of infection can be a bacteria or germ called Pseudomonas (pronounced sue-doe-moe-nas). When Pseudomonas is first found in the lungs of CF patients they are treated with antibiotics (a type of medicine) to get rid of the germ. There is a choice of treatment that can then be used to get rid of the Pseudomonas – either antibiotics taken by mouth (orally) or given intravenously (by a tube into the vein). These treatments are usually combined with antibiotics that are inhaled as a mist directly into your lungs through a machine called a nebuliser. We know that both treatment types work well at getting rid of Pseudomonas and preventing damage to the lungs, but we don't know if one treatment is better than the other. The only way to find out which of these treatments is better is to carry out a research project called a clinical trial where patients are given either one of two different treatment options at random (50/50 chance of getting either treatment). We have therefore designed a study to compare the two treatments to find out whether there is any difference between two different antibiotic treatments.
What does the study involve?
You will be randomly allocated to be treated with either antibiotics taken by mouth (orally) or given intravenously (by a tube into the vein). The study will last for 24 months, and during that time your study doctor will collect information about your response to the study treatment and overall medical history. You will also be asked to complete a few short questionnaires at each study visit. During your treatment, the doctor or nurse may take a little bit of blood from your arm, and during your visits they will collect sputum (mucous you cough up from your lungs), ask you how you feel, and get you to blow into a machine to check your lungs. You will be asked to come into hospital for nine study visits. Depending on how frequent your routine clinic visits are, some or all of the study visits will be scheduled to occur at the same time as your routine clinic visits.
Phase
The different stages involved in the development of a new medication. Phase I focuses on initial safety in people. Phase 2 evaluates safety, correct dose and early signs of whether the medication works. Phase 3 is the stage before medication licensing and looks at safety and medication effectiveness. Phase 4 evaluates longer term use of a medication after it has been licensed for use
Phase 3
Length of participation
The length of time a participant will take part in a trial, from the first to the last appointment
24 months
Recruitment target
The number of participants who need to be recruited for the trial in the UK
280
CF sponsor
University Hospitals Bristol
CF sponsor type
Academic
Who can take part?
Age range
Over 28 days old
Including people
Children over the age of 28 days, older children and adult CF participants are all eligible with no upper age limitation.
The patient should have isolated P.aeruginosa and should be either:
5.1. P. aeruginosa-naïve (i.e., has never previously isolated P. aeruginosa) or P. aeruginosa-free (i.e., a minimum number of four consecutive cough or sputum samples should be P. aeruginosa free within a 12 month period to satisfy eligibility)
Excluding people
Antibiotic resistance of the current P.aeruginosa sample to any of: ciprofloxacin, ceftazidime, tobramycin or colistin reported by local microbiology laboratory.Known patient hypersensitivity to either ciprofloxacin, ceftazidime, tobramycin or colistin
Treatment with other anti-pseudomonal nebuliser
