Pharmacokinetic Study of Aerosolized Colimycin in Cystic Fibrosis

Poitiers University Hospital7 enrolled

Overview

Pharmacokinetics of colimycin will be assessed during 12 hours after administration of 2M UI colimycin either as an aerosol or after IV injection, the administration being separated by 5 to 10 days intervals

Study Type

INTERVENTIONAL

Enrollment

Conditions

Cystic Fibrosis

Interventions

COLIMYCINE inhalationDRUG

2 MILLION UI

COLIMYCINE injectableDRUG

2 MILLIONS UI

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Males and females, adults. * Suffering from stable cystic fibrosis * Colonized by P. aeruginosa * Having given informed consent. * Able to follow the protocol * Having a social insurance Exclusion Criteria: * Renal insufficiency * Allergy to colistin or polymixins * Myasthenia * Recent severe hemoptysis * Liver cirrhosis and hepatic insufficiency * Hypoalbuminemia * Colonization by Burkholderia cepaea or Stenotrophomonas maltophilin * Pregnancy

Locations (1)

Poitiers University Hospital

Poitiers, France

Data from ClinicalTrials.gov

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