Pharmacokinetic Study of Aerosolized Colimycin in Cystic... | NCT01537614

Studies
Pharmacokinetic Study of Aerosolized Colimycin in Cystic Fibrosis

NCT01537614

Sponsor

Poitiers University Hospital

Status

Completed

Last Update Posted

Oct 11, 2016Estimated

Enrollment

7Actual

Phase

Phase 1

Conditions

Cystic Fibrosis

Interventions

COLIMYCINE inhalation
COLIMYCINE injectable

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2011

Primary Completion Date

Feb 2013Actual

Completion Date

Not provided

First Submitted Date

Feb 17, 2012

First Submission Date that Met QC Criteria

Feb 22, 2012

First Posted Date

Feb 23, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 10, 2016

Last Update Posted Date

Oct 11, 2016Estimated

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

No data available

No data is available for this block.

Biospecimen

No data available

No data is available for this block.

Enrollment

7Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
COLIMYCINE injectable	Experimental		Drug: COLIMYCINE injectable
COLIMYCINE inhalation	Experimental		Drug: COLIMYCINE inhalation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
COLIMYCINE inhalation	Drug	2 MILLION UI	COLIMYCINE inhalation
COLIMYCINE injectable

Eligibility Module

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

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Poitiers University Hospital		Poitiers		86021	France

Condition Browse Module

MeSH Terms

ID	Term
D003550	Cystic Fibrosis

Ancestor Terms

ID	Term
D010182	Pancreatic Diseases
D004066	Digestive System Diseases
D008171	Lung Diseases
D012140	Respiratory Tract Diseases

Browse Leaves

Not provided

Browse Branches

Not provided