Pharmacokinetic Study of Aerosolized Colimycin in Cystic Fibrosis (COLI-VLM)

Poitiers University Hospital

Status and phase: Completed; Phase 1

Conditions: Cystic Fibrosis

Treatments: Drug: COLIMYCINE injectable; Drug: COLIMYCINE inhalation

Study type: Interventional

Funder types: Other

Identifiers

NCT01537614

COLI-VLM

Details and patient eligibility

About

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

Enrollment: 7 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

7 participants in 2 patient groups

COLIMYCINE injectable

Experimental group

Treatment:

Drug: COLIMYCINE injectable

COLIMYCINE inhalation

Experimental group

Treatment:

Drug: COLIMYCINE inhalation