RecruitingPhase 4ACTRN12609000016235

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?


Sponsor

Royal Adelaide Hospital

Enrollment

24 participants

Start Date

Oct 1, 2008

Study Type

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

Sex: Both males and femalesMin Age: 6 Yearss

Plain Language Summary

Simplified for easier understanding

This study is looking at a different way to deliver a common antibiotic called tobramycin to people with cystic fibrosis who have a lung flare-up (called an exacerbation). Normally, tobramycin is given directly into a vein (intravenously). This study will test whether breathing in the antibiotic through an inhaler gives the lungs enough of the drug to fight the infection just as well. Each participant will receive both methods at different times so researchers can compare how well each one works. You may be eligible if: - You have been diagnosed with cystic fibrosis - You are 6 years of age or older - Your lungs are chronically infected with a bacterium called Pseudomonas aeruginosa - Your lung function (FEV1) is above 25% - You are being admitted to hospital for a lung infection flare-up You may NOT be eligible if: - You have a fever above 38.0°C - You are allergic to aminoglycoside antibiotics - Your kidneys are not working well enough (creatinine clearance below 50 mL/min) 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

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 300m

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)

Australia

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ACTRN12609000016235


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