CISTICContinuous-infusion Anti-pseudomonal β-lactams for the Treatment of Acute, Infective Pulmonary Exacerbations in Cystic Fibrosis
Intermittent, short infusion Ceftazidime
+ Intermittent, short infusion Meropenem
+ Intermittent, short infusion Ticarcillin-clavulanate
Digestive System Diseases+5
+ Infant, Newborn, Diseases
+ Lung Diseases
Treatment Study
Summary
Study start date: September 1, 2012
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.50 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria: Patients >= 18 years of age, Pseudomonas aeruginosa isolated in sputum within the last 12 months, has an acute infective exacerbation, defined by international standards of 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: patients < 18 yrs of age, patients that do not meet the criteria for an acute infective exacerbation, concurrent pulmonary embolism, significant haemoptysis, pneumothorax, or respiratory failure, impaired renal function with an estimated creatinine clearance < 60 mls/min, patients allergic to ß-lactam antibiotics, aminoglycoside contra-indicated, intravenous antibiotics in the last 2 weeks, prior to this admission, received more than 24 hours of intravenous antibiotics in this admission, previous lung transplantation, pregnancy or lactation, or inability to consent.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
Active ComparatorGroup II
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location