NCT01667094.
Trial name or title | Continuous infusion anti‐pseudomonal beta‐lactams for the treatment of acute, infective pulmonary exacerbations in cystic fibrosis: a prospective randomised controlled trial |
Methods | Randomised, open‐label trial |
Participants | Estimated enrolment = 120, adults with cystic fibrosis with Pseudomonas aeruginosa isolated in sputum within the past 12 months with an acute infective exacerbation |
Interventions | Short infusion over 30 minutes of either cefepime 1 g i.v. q8h OR ceftazidime 2 g i.v. q8h OR meropenem 1 g i.v. q8h OR piperacillin‐tazobactam 4.5 g i.v. q8h OR ticarcillin‐clavulanate 3.1 g i.v. q6h vs continuous infusion of either cefepime 500 mg i.v. loading dose, then 1.5 g i.v. infused over 12 h q12h OR ceftazidime 1 g i.v. loading dose, then 3 g i.v. infused over 12 h q12h OR meropenem 500 mg i.v. loading dose, then 1.5 g i.v. infused over 12 h q12h OR piperacillin‐tazobactam 1.55 g i.v. loading dose, then 13.5 g i.v. infused over 24 h |
Outcomes | Primary outcome: cystic fibrosis questionnaire‐revised respiratory component respiratory symptom score Secondary outcomes: change in cystic fibrosis questionnaire‐revised respiratory symptom score, lung function testing/FEV1, C‐reactive peptide, quantitative bacterial load in sputum, time above MIC, antibiotic stability, Pseudomonas aeruginosa virulence gene determinants |
Starting date | September 2012 |
Contact information | Katherine Langan (Katherine.Langan@monash.edu.au) |
Notes | Estimated study completion date January 2015 |