Study design (if review, criteria of inclusion for studies)
Multi-centre parallel group, randomised controlled trial
Participants
All cystic fibrosis patients who have isolated P.aeruginosa and fulfil the inclusion criteria from participating centres will be considered eligible to take part in the trial
Interventions
This trial aims to examine whether ten days intravenous ceftazidime with tobramycin is superior to oral ciprofloxacin. Both treatment arms will receive three months of nebulised colistin in conjunction to the randomised treatment
Outcome measures
The primary outcome measure will be successful eradication of P.aeruginosa infection at three months post randomisation, and remaining infection free through to 15 months post randomisation. Secondary outcomes will include time to recuurence of P.aeruginosa infection, time to new P.aeruginosa infection, lung function, growth and nutritional status, number of pulmonary exacerbations, admission to hospital, number of days spent as inpatient, quality of life, utility, adverse events, reinfection with a different strain of Pseudomonas, other sputum/cough microbiology, candida infection, cost per patient, incremental cost effectiveness ratio, carer burden (as measured by number of days missed from school or work)
Related topics
Antibiotic treatment for stenotrophomonas maltophilia in people with cystic fibrosis
Antibiotic treatment of early pseudomonas aeruginosa
Antibiotics for pulmonary exacerbations
Inhaled antibiotics in cystic fibrosis
Prophylactic use of oral antistaphylococcal antibiotic
Scheduled antibiotics every 3-4 months / symptom-based treatment