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

Tracking Information

First Received Date ^ICMJE

February 17, 2012

Last Updated Date

February 23, 2012

Start Date ^ICMJE

Not Provided

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Not Provided

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT01537614 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Pharmacokinetic Study of Aerosolized Colimycin in Cystic Fibrosis

Official Title ^ICMJE

Not Provided

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

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Not Provided

Condition ^ICMJE

Cystic Fibrosis

Intervention ^ICMJE

Drug: COLIMYCINE inhalation
2 MILLION UI
Drug: COLIMYCINE injectable
2 MILLIONS UI

Study Arm (s)

Experimental: COLIMYCINE injectable
Intervention: Drug: COLIMYCINE injectable
Experimental: COLIMYCINE inhalation
Intervention: Drug: COLIMYCINE inhalation

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Enrollment ^ICMJE

Not Provided

Completion Date

Not Provided

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Not Provided

Contacts ^ICMJE

Contact: Patrice DIOT, MD

33 2 47 47 80 32

diot@med.univ-tours.fr

Location Countries ^ICMJE

France

Administrative Information

NCT Number ^ICMJE

NCT01537614

Other Study ID Numbers ^ICMJE

COLI-VLM

Has Data Monitoring Committee

Not Provided

Responsible Party

Poitiers University Hospital

Study Sponsor ^ICMJE

Poitiers University Hospital

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Not Provided

Information Provided By

Poitiers University Hospital

Verification Date

February 2012

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

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