NCT01537614

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

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2011

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

February 17, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 23, 2012

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2013

Completed
Last Updated

October 11, 2016

Status Verified

October 1, 2016

Enrollment Period

1.3 years

First QC Date

February 17, 2012

Last Update Submit

October 10, 2016

Conditions

Cystic Fibrosis

Study Arms (2)

COLIMYCINE injectable

EXPERIMENTAL
Drug: COLIMYCINE injectable

COLIMYCINE inhalation

EXPERIMENTAL
Drug: COLIMYCINE inhalation

Interventions

COLIMYCINE inhalationDRUG

2 MILLION UI

COLIMYCINE inhalation
COLIMYCINE injectableDRUG

2 MILLIONS UI

COLIMYCINE injectable

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Poitiers University Hospital

Poitiers, 86021, France

Location

MeSH Terms

Conditions

Cystic Fibrosis

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System DiseasesLung DiseasesRespiratory Tract DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesInfant, Newborn, Diseases

Study Design

Study Type
interventional
Phase
phase 1
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 17, 2012

First Posted

February 23, 2012

Study Start

October 1, 2011

Primary Completion

February 1, 2013

Last Updated

October 11, 2016

Record last verified: 2016-10

Locations

FR(1)