Overview

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