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

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ClinicalTrials.gov Identifier: NCT01537614
Recruitment Status : Completed
First Posted : February 23, 2012
Last Update Posted : October 11, 2016
Sponsor:
Information provided by (Responsible Party):
Poitiers University Hospital

Brief Summary:
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 or disease Intervention/treatment Phase
Cystic Fibrosis Drug: COLIMYCINE inhalation Drug: COLIMYCINE injectable Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Study Start Date : October 2011
Actual Primary Completion Date : February 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cystic Fibrosis
U.S. FDA Resources

Arm Intervention/treatment
Experimental: COLIMYCINE injectable Drug: COLIMYCINE injectable
2 MILLIONS UI
Experimental: COLIMYCINE inhalation Drug: COLIMYCINE inhalation
2 MILLION UI




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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

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

Responsible Party: Poitiers University Hospital
ClinicalTrials.gov Identifier: NCT01537614     History of Changes
Other Study ID Numbers: COLI-VLM
First Posted: February 23, 2012    Key Record Dates
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