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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01537614
First Posted: February 23, 2012
Last Update Posted: October 11, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Poitiers University Hospital
  Purpose
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
2 MILLIONS UI
Experimental: COLIMYCINE inhalation Drug: COLIMYCINE inhalation
2 MILLION UI

  Eligibility

Information from the National Library of Medicine

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

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01537614


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

Responsible Party: Poitiers University Hospital
ClinicalTrials.gov Identifier: NCT01537614     History of Changes
Other Study ID Numbers: COLI-VLM
First Submitted: February 17, 2012
First Posted: February 23, 2012
Last Update Posted: October 11, 2016
Last Verified: October 2016

Additional relevant MeSH terms:
Fibrosis
Cystic Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases