Pharmacokinetic Study of Aerosolized Colimycin in Cystic Fibrosis

Phase 1

Completed

• Conditions: Cystic Fibrosis
• Interventions: Drug: COLIMYCINE injectable; Drug: COLIMYCINE inhalation

• Registration Number: NCT01537614
• Lead Sponsor: Poitiers University Hospital

Brief 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

Detailed Description

Not available

Study Timeline

• Study Start: 2011-10
• Study First Submitted: 2012-02-17
• Study First Submitted QC: 2012-02-22
• Study First Posted: 2012-02-23
• Primary Completion: 2013-02
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-10
• Last Update Posted: 2016-10-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 7

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
COLIMYCINE injectable	COLIMYCINE injectable	-
COLIMYCINE inhalation	COLIMYCINE inhalation	-

Trial Locations

Locations (1)

Poitiers University Hospital; 🇫🇷 Poitiers, France