RecruitingPhase 4ACTRN12612000945820

Continuous infusion antipseudomonal beta-lactams for acute infective exacerbations in cystic fibrosis: a prospective randomised controlled trial

Continuous infusion antipseudomonal betalactams versus standard short infusions in the treatment of acute infective exacerbations in patients with cystic fibrosis - impact on clinical and microbiological outcomes


Sponsor

Dr Anton Peleg

Enrollment

120 participants

Start Date

Nov 26, 2012

Study Type

Interventional

Conditions

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.


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This study is testing a different way of giving antibiotics to adults with cystic fibrosis (CF) who are having a lung infection flare-up caused by a bacterium called Pseudomonas aeruginosa. Normally these antibiotics are given as short infusions several times a day. This trial gives the same antibiotics as a continuous drip throughout the day to keep steady levels in the blood and lungs at all times. Researchers want to see if this continuous method clears the infection better and improves lung function. You may be eligible if: - You are 18 years of age or older - You have cystic fibrosis and Pseudomonas aeruginosa has been detected in your sputum in the past 12 months - You are having an acute lung infection flare, shown by at least 2 of these signs in the past 2 weeks: change in sputum colour or amount, more coughing, more shortness of breath, fatigue or feeling unwell, loss of appetite or weight, a drop in lung function of 10% or more, or new changes on chest X-ray You may NOT be eligible if: - You are under 18 years old - You do not meet the criteria for an acute lung flare - You have previously participated in this study - You have a pulmonary embolism, significant coughing of blood, collapsed lung, or respiratory failure - Your kidneys are not working well enough (creatinine clearance below 60 mL/min) - You are allergic to beta-lactam antibiotics - You cannot receive aminoglycoside antibiotics - You have received intravenous antibiotics in the 2 weeks before this admission - You have already received more than 24 hours of intravenous antibiotics in this admission - You have had a lung transplant - You are pregnant or breastfeeding - You are unable to give consent Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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. Participant

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.


Locations(1)

Australia

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ACTRN12612000945820