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

This study has been completed.
Information provided by (Responsible Party):
Poitiers University Hospital Identifier:
First received: February 17, 2012
Last updated: October 10, 2016
Last verified: October 2016
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

Condition Intervention Phase
Cystic Fibrosis Drug: COLIMYCINE inhalation Drug: COLIMYCINE injectable Phase 1

Study Type: Interventional

Resource links provided by NLM:

Further study details as provided by Poitiers University Hospital:

Enrollment: 7
Study Start Date: October 2011
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: COLIMYCINE injectable Drug: COLIMYCINE injectable
Experimental: COLIMYCINE inhalation Drug: COLIMYCINE inhalation


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01537614

Poitiers University Hospital
Poitiers, France, 86021
Sponsors and Collaborators
Poitiers University Hospital
  More Information

Responsible Party: Poitiers University Hospital Identifier: NCT01537614     History of Changes
Other Study ID Numbers: COLI-VLM
Study First Received: February 17, 2012
Last Updated: October 10, 2016

Additional relevant MeSH terms:
Cystic Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases processed this record on September 21, 2017