We aim to study whether the use of inhaled antibiotics may have an impact on the incidence of
tracheobronchitis and pneumonia associated with the use of mechanical ventilation. The
investigators hypothesize that this could be possible by decreasing the population of gram
negative germs that colonize the lumen of tracheal tube and upper airways.
Comparison of 2 Treatment Regimens for Eradication of P Aeruginosa Infection in Children With Cystic Fibrosis
Completed
Universitaire Ziekenhuizen Leuven
Phase 4
2001-08-01
Treatment of new Pseudomonas aeruginosa (Pa) infection in cystic fibrosis (CF) can postpone
chronic infection. Aim of the study: compare 2 Pa eradication regimens in children with new
Pa infection.
This is a clinical study protocol for a single centre, randomized, double blind, placebo
controlled, single and repeat dose study to investigate the safety, tolerability and
pharmacokinetics of intravenous dosing of Colistin Methanesulfonate Sodium (CMS-Na) in
healthy Japanese male subjects.
Eighteen subjects will receive CMS-Na 2.5mg/kg (as colistin activity or 75,000 IU/kg) or
placebo as a single dose and twice daily for 2.5 days by intravenous infusion.
Blood and urine samples for pharmacokinetics analysis will be taken at regular intervals
after dosing. Safety will be assessed by measurement of vital signs, Echocardiogram (ECGs),
safety laboratory data, renal function and review of adverse events.
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