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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2012 by Poitiers University Hospital.
Recruitment status was  Recruiting
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

February 17, 2012
February 23, 2012
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Complete list of historical versions of study NCT01537614 on ClinicalTrials.gov Archive Site
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Pharmacokinetic Study of Aerosolized Colimycin in Cystic Fibrosis
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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

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Interventional
Phase 1
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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
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
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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
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Contact: Patrice DIOT, MD 33 2 47 47 80 32 diot@med.univ-tours.fr
France
 
NCT01537614
COLI-VLM
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Poitiers University Hospital
Poitiers University Hospital
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Poitiers University Hospital
February 2012

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