Pharmacokinetic Study of Aerosolized Colimycin in Cystic Fibrosis

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01537614

Acronym

COLI-VLM

Enrollment

Registered

2012-02-23

Start date

2011-10-31

Completion date

Unknown

Last updated

2016-10-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cystic Fibrosis

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

Interventions

DRUGCOLIMYCINE inhalation

2 MILLION UI

DRUGCOLIMYCINE injectable

2 MILLIONS UI

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026