Duration of antibiotics in infective exacerbations of cystic fibrosis

• Research type

  Research Study

• Full title

  What duration of intravenous antibiotic therapy should be used in the treatment of infective exacerbations of cystic fibrosis in patients chronically colonised with Pseudomonas aeruginosa?

• IRAS ID

  24144

• Sponsor organisation

  Imperial College, London

• Eudract number

  2009-014042-28

• ISRCTN Number

  n/a

• Research summary

  Cystic fibrosis (CF) is the most common lethal inherited disorder in Caucasian populations with an incidence of 1 in 2500 live births and a carrier frequency of 1 in 25. The commonest cause of death and sickness in CF is respiratory infection with the most common bug being Pseudomonas aeruginosa. Infective exacerbations of CF are usually treated with intravenous (IV) antibiotics.Patients have been treated for 10-21 days but the optimal duration of IV antibiotic therapy has not been defined. The CF Trust recommends a minimum of 10 days whereas a European consensus suggested a course of 14 days. Shorter courses of antibiotics would be less expensive both in money costs, with shorter inpatient stays and less medication, and in terms of time off from work/study for patients. They may also be associated with decreased antibiotic resistance and allergic reactions. However, longer courses may lengthen the time to the next exacerbation requiring antibiotics. A recent Cochrane review has revealed that there are no studies to date comparing different durations of therapy and called for a good quality randomised controlled trial.Our study will recruit all suitable patients over a one year period as they attend for treatment for infective exacerbations at the Royal Brompton Hospital. Our aim is to exclude as few patients as possible to allow us to mirror clinical practice. Study participants will be randomised to 10, 14 or 21 days of IV antibiotics. Measurements of lung function, serum inflammatory markers and symptom questionnaires will be used to determine treatment success. We will also be examining the effect on sputum microbiology in terms of the level of bacteria seen, during and after treatment, and the development of antibiotic resistance. Study participants will be followed up for 6 months to determine the time to the next infective exacerbation.

• REC name

  London - Surrey Borders Research Ethics Committee

• REC reference

  09/H0806/50

• Date of REC Opinion

  16 Oct 2009

• REC opinion

  Further Information Favourable Opinion