Continuous infusion antipseudomonalbeta-lactams for acute infective exacerbations in cystic fibrosis: a prospective randomised controlled trial
- Conditions
- Acute pulmonary exacerbation of cystic fibrosisInfection - Studies of infection and infectious agentsRespiratory - Other respiratory disorders / diseasesHuman Genetics and Inherited Disorders - Cystic fibrosis
- Registration Number
- ACTRN12612000945820
- Lead Sponsor
- Dr Anton Peleg
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 120
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
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in Cystic Fibrosis Questionnaire-Revised (CFQ-R) respiratory symptom score[Day 0 to Day 14]
- Secondary Outcome Measures
Name Time Method