Pharmacokinetic Study of Aerosolized Colimycin in Cystic Fibrosis

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1

Details

• Lead Sponsor: Poitiers University Hospital

Criteria

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