Children and adults with cystic fibrosis are prone to chest infections and these infections can cause long term damage to the lungs, which can affect the health and long term survival of the patient. There are a number of different organisms that cause these infections, one of the most important of which is known as Pseudomonas aeruginosa (there is no lay term for this organism). Usually when this bacteria is first found in the sputum or cough swab patients are treated with antibiotics to get rid of (eradicate) the bacteria. There is a choice of treatment that can then be used to eradicate the bacteria – either antibiotics taken by mouth (orally) or given directly into the vein usually in the arm or the back of the hand (intravenously, IV). Sometimes doctors choose to treat the patient in the community with three months of oral and at least three months of nebulised antibiotics and sometimes choose to admit the patient to hospital and treat for 10-14 days with intravenous treatment as well as continuing the same nebulised treatment for three months. Despite there being substantial differences to the patient and family in terms of what these two treatment choices offer, at present it is not possible for medical teams to say if intravenous treatment is better than oral treatment in terms of their ability to totally clear the infection from the body. The TORPEDO study addresses this question and will also address the question of cost of each form of treatment. Cost will be measured in terms of direct costs of the treatment including cost of medication and of giving the medication (including the cost of hospital admission where appropriate) and in terms of indirect costs such as time missed from school and work and the relative amount of inconvenience experienced by the patient and family for each form of treatment. This study will recruit 286 patients from Cystic Fibrosis centres throughout the UK. Participants were randomised to 14 days intravenous ceftazidime and tobramycin or three months oral ciprofloxacin. Both were combined with three months inhaled colistimethate sodium.
- Tudur Smith, C., et al. (2014). "Risk-proportionate clinical trial monitoring: an example approach from a non-commercial trials unit." Trials 15(1): 127.