None listed
Conditions
Brief summary
Cystic fibrosis (CF) is an inherited disorder which results in increased thickness of secretions, especially in the lungs. By adulthood, the majority of patients with CF will have a bacteria living in their lungs, called Pseudomonas aeruginosa which can cause lung infections. This usually results in worsening respiratory symptoms and often an acute deterioration in their lung function. They are usually treated with antibiotics that target the Pseudomonas aeruginosa. These antibiotics are typically given as short intravenous infusions several times a day. This study aims to compare the standard method of giving these antibiotics with a different strategy of giving these antibiotics to see if this can improve the outcomes of treatment of these infections and reduce the amount of Pseudomonas aeruginosa in the lungs of these patients. This strategy consists of giving the same antibiotics continuously, to ensure there is always enough antibiotic in the bloodstream and the lung to be able to kill the bacteria.
Interventions
Continuous infusion antipseudomonal beta-lactam. The antipseudomonal beta-lactam will be chosen by the treating physician and the method of administration will be subject to randomisation. Participants will receive ONE of the following intravenous antibiotics, as decided by their treating physician. Ceftazidime: Loading dose 500mg on day 1 then 3g infused over 24 hours continuously or Ticarcillin-clavulanate: Loading dose 1.5g ticarcillin/0.05g clavulanate on day 1 then 12g ticarcillin/0.4g clav
Continuous infusion antipseudomonal beta-lactam. The antipseudomonal beta-lactam will be chosen by the treating physician and the method of administration will be subject to randomisation. Participants will receive ONE of the following intravenous antibiotics, as decided by their treating physician. Ceftazidime: Loading dose 500mg on day 1 then 3g infused over 24 hours continuously or Ticarcillin-clavulanate: Loading dose 1.5g ticarcillin/0.05g clavulanate on day 1 then 12g ticarcillin/0.4g clavulanate infused over 24 hours continuously or Meropenem: Loading dose 500mg on day 1 then 3g infused over 24 hours continuously or Cefepime: Loading dose 500mg on day 1 then 3g infused over 24 hours continuously or Piperacillin-tazobactam: Loading dose 2g piperacillin/0.25g tazobactam on day 1 then 16g piperacillin/2g tazobactam infused over 24 hours continously 24 hour infusions are repeated daily over the 14 day treatment period, i.e. continuous infusion for 14 days.
Sponsors
Dr Anton Peleg
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1) Patients greater than or equal to 18 years of age, 2) Pseudomonas aeruginosa isolated in sputum within the last 12 months, 3) has an acute infective exacerbation, defined by international standards 2 or more of the following in the last 2 weeks: change sputum volume or colour, increased cough, increased dyspnoea, increased malaise, fatigue or lethargy, anorexia or weight loss, decrease in pulmonary function by 10% or more, or new radiographic changes
Exclusion criteria
1) patients < 18 yrs of age, 2) patients that do not meet the criteria for an acute infective exacerbation, 3) previous enrolment in the study, 4) concurrent pulmonary embolism, significant haemoptysis, pneumothorax, or respiratory failure, 5) impaired renal function with an estimated creatinine clearance < 60 mls/min, 6) patients allergic to beta-lactam antibiotics, 7) aminoglycoside contra-indicated, 8) intravenous antibiotics in the last 2 weeks, prior to this admission, 9) received more than 24 hours of intravenous antibiotics in this admission, 10) previous lung transplantation, 11) pregnancy or lactation, or 12) inability to consent.
Outcome results
None listed