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

This study is currently recruiting participants.
Verified February 2012 by Poitiers University Hospital
Sponsor:
Information provided by (Responsible Party):
Poitiers University Hospital
ClinicalTrials.gov Identifier:
NCT01537614
First received: February 17, 2012
Last updated: February 23, 2012
Last verified: February 2012
History of Changes
  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:

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

Further study details as provided by Poitiers University Hospital:

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
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01537614

Contacts
Contact: Patrice DIOT, MD 33 2 47 47 80 32 diot@med.univ-tours.fr

Locations
France
Poitiers University Hospital Recruiting
Poitiers, France, 86021
Contact: Patrice DIOT, MD     33 2 47 47 80 32     diot@med.univ-tours.fr    
Sponsors and Collaborators
Poitiers University Hospital
  More Information

No publications provided

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: February 23, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

ClinicalTrials.gov processed this record on May 19, 2013