Pharmacokinetic Study of Aerosolized Colimycin in Cystic Fibrosis

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

  • Study Type: Interventional
  • Study Primary Completion Date: February 2013

Interventions

  • Drug: COLIMYCINE inhalation
    • 2 MILLION UI
  • Drug: COLIMYCINE injectable
    • 2 MILLIONS UI

Arms, Groups and Cohorts

  • Experimental: COLIMYCINE injectable
  • Experimental: COLIMYCINE inhalation

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Investigator Details

  • Lead Sponsor
    • Poitiers University Hospital
  • Provider of Information About this Clinical Study
    • Sponsor

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