Pulmonary exacerbation in adult patients with cystic fibrosis (CF) Respiratory Cystic fibrosis (CF)
Conditions
Interventions
Patients randomised to the control group will receive a 14 days course of any two intravenous antibiotics ± one inhaled antibiotic (tobramycin/TOBI) chosen by their physicians based on usual culture a
Sponsors
Ottawa Hospital Research Institute (Canada)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age greater than or equal to 12, either sex 2. A confirmed diagnosis of cystic fibrosis (a sweat chloride value higher than 60 mmol/litre or two disease-causing mutations) 3. Chronically colonised with multi-resistant P. aeruginosa, or S. maltophilia, or A. xylosidans (at least two sputum cultures within the last 12 months which have grown these multi-resistant bacteria, one of which must have been obtained within six months of randomisation) 4. Patients must be known to be chronically colonised with Burkholderia cepacia bacteria (at least two sputum cultures within the last 12 months which have grown Burkholderia cepacia, one of which must have been obtained within six months of randomisation) 5. Patients must be able to spontaneously produce sputum for culturing
Exclusion criteria
Exclusion criteria: 1. Unable to give informed consent 2. Previous lung transplant recipients 3. Patients with severe pulmonary exacerbations who require admission to an Intensive Care Unit (ICU) and/or mechanical ventilatory support 4. Patients who are already receiving continuous home intravenous antibiotic therapy 5. Pregnant patients
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The time (days) from randomisation until the patient's next pulmonary exacerbation. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Mean changes in sputum bacterial densities for day zero to day 14 2. Changes in pulmonary function, pre-bronchodilator forced expiratory volume in one second (FEV1), and forced vital capacity (FVC) 3. Changes in oxygenation from day zero to day 14 4. The proportion of antibiotic treatment failures in both treatment groups within 14 days 5. Changes in subjective dyspnoea score from day zero to day 14 6. Length of hospital stay, for patients admitted to hospital 7. Adverse effects related to antibiotic therapy | — |
Countries
Canada
Outcome results
None listed