A randomised cross over pilot study of inhaled tobramycin as a treatment option for hospitalised patients with cystic fibrosis versus standard treatment of intravenous tobramycin
Is inhaled tobramycin as effective as intravenous tobramycin and potentially less toxic for treating acute exacerbations of lung infection in those patients with cystic fibrosis (CF) who are chronically colonised with Pseudomonas aeruginosa?
Royal Adelaide Hospital
24 participants
Oct 1, 2008
Interventional
Conditions
Summary
This study hopes to show that when tobramycin is given via inhalation in those patients with cystic fibrosis who are sick enough to need intravenous (into a vein) antibiotics, the levels in the lung are adequate for effective bacteria killing and that they recover from the acute infection. The study will be undertaken in all eligible patients who are admitted to the hospital for treatment of an exacerbation of their lung infection.
Eligibility
Inclusion Criteria1
- Diagnosis of cystic fibrosis, chronically colonised with Pseudomonas aeruginosa, Forced Expiratory Volume in 1 second (FEV1) > 25%, having an exacerbation of their lung infection
Exclusion Criteria1
- Patients who are pyrexial with a temperature of >38.0C , allergic to aminoglycosides, patients with calculated creatinine clearance <50mL/min/1.73m2
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
Each participant will receive either IV tobramycin at the dose they received on their last admisson (usually 7-10mg/kg) once daily for 14 days or they will receive inhaled tobramycin at a dose of 300mg twice a day for 14 days. Once thier treatment has been completed they will cease these medications and will receive the other arm of the study on their next admission. Their admissions must be a minimum of 6 weeks apart.
Locations(1)
View Full Details on ANZCTR
For the most up-to-date information, visit the official listing.
ACTRN12609000016235