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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Poitiers University Hospital
ClinicalTrials.gov Identifier:
NCT01537614
First received: February 17, 2012
Last updated: October 10, 2016
Last verified: October 2016
  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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: February 17, 2012
Last Updated: October 10, 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

ClinicalTrials.gov processed this record on March 23, 2017