Pharmacokinetic Study of Aerosolized Colimycin in Cystic Fibrosis

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

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Key information

Conditions

Cystic Fibrosis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Digestive System Diseases Genetic Diseases, Inborn Infant, Newborn, Diseases Lung Diseases Pancreatic Diseases Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Poitiers University Hospital

Poitiers, 86021, France

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

COLIMYCINE inhalation

Drug

2 MILLION UI

COLIMYCINE injectable

Drug

2 MILLIONS UI

Sponsors and collaborators

Lead sponsor

Poitiers University Hospital

Other

Registry information

Acronym: COLI-VLM

Important dates

Study start: 2011
Primary completion: 2013
First posted: Feb 23, 2012
Registry last updated: Oct 11, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed