TORPEDO-CF

Details

Therapeutic category
Anti-Infective
Trial status
Closed - follow up complete Participating Centres
Phase
Phase III

Full title

Trial of Optimal Therapy for Pseudomonas Eradication in Cystic Fibrosis

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.

Trial Reference Number
4097
Trial type
Medication
Length of participation
24 months
Intervention
Arm A: 14 days Intravenous (iv) Ceftazidime 50 miligram (mg)/kilogram (kg)/dose, to a maximum of 3 grams (g) three times daily (tds) and IV tobramycin 10mg/kg/dose once daily (od) (maximum 660mg / day)

Arm B: 3 months oral ciprofloxacin twice daily (bd) (Ciprofloxacin dose will be 15 mg/kg/dose twice daily for children aged < 5 years and 20 mg/kg/dose twice daily (maximum 750mg twice daily) for those aged ≥ 5 years)

Both treatment arms will receive three months of nebulised colistin in conjunction to the randomised treatment. Colistin dose will be as recommended by the UK CF Trust: 1,000,000 units twice daily for children aged ≤ 2 years and 2,000,000 units twice daily for children aged >2 years and adults.
Recruitment target
280
Last edited date
29/10/2018
CF sponsor
University Hospitals Bristol
CF sponsor type
Academic

Who can take part?

Top inclusion criteria
  • 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)
Top exclusion criteria
  • 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

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