Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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

February 17, 2012
October 10, 2016
October 2011
February 2013   (final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT01537614 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Pharmacokinetic Study of Aerosolized Colimycin in Cystic Fibrosis
Not Provided
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
Not Provided
Interventional
Phase 1
Not Provided
Cystic Fibrosis
  • Drug: COLIMYCINE inhalation
    2 MILLION UI
  • Drug: COLIMYCINE injectable
    2 MILLIONS UI
  • Experimental: COLIMYCINE injectable
    Intervention: Drug: COLIMYCINE injectable
  • Experimental: COLIMYCINE inhalation
    Intervention: Drug: COLIMYCINE inhalation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
7
Not Provided
February 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older   (Adult, Senior)
Not Provided
Contact information is only displayed when the study is recruiting subjects
France
 
NCT01537614
COLI-VLM
Not Provided
Not Provided
Not Provided
Poitiers University Hospital
Poitiers University Hospital
Not Provided
Not Provided
Poitiers University Hospital
October 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP