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

Primary Purpose

Cystic Fibrosis

Status
Completed
Phase
Phase 1
Locations
France
Study Type
Interventional
Intervention
COLIMYCINE inhalation
COLIMYCINE injectable
Sponsored by
Poitiers University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional trial for Cystic Fibrosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All Sexes

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

Sites / Locations

  • Poitiers University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

COLIMYCINE injectable

COLIMYCINE inhalation

Arm Description

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
February 17, 2012
Last Updated
October 10, 2016
Sponsor
Poitiers University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01537614
Brief Title
Pharmacokinetic Study of Aerosolized Colimycin in Cystic Fibrosis
Acronym
COLI-VLM
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
February 2013 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Poitiers University Hospital

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cystic Fibrosis

7. Study Design

Study Phase
Phase 1
Enrollment
7 (Actual)

8. Arms, Groups, and Interventions

Arm Title
COLIMYCINE injectable
Arm Type
Experimental
Arm Title
COLIMYCINE inhalation
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
COLIMYCINE inhalation
Intervention Description
2 MILLION UI
Intervention Type
Drug
Intervention Name(s)
COLIMYCINE injectable
Intervention Description
2 MILLIONS UI

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Eligibility 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
Facility Information:
Facility Name
Poitiers University Hospital
City
Poitiers
ZIP/Postal Code
86021
Country
France

12. IPD Sharing Statement

Learn more about this trial

Pharmacokinetic Study of Aerosolized Colimycin in Cystic Fibrosis

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