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NCT01537614 Clinical Trial

Pharmacokinetic Study of Aerosolized Colimycin in Cystic Fibrosis

Cystic Fibrosis Clinical Trial

— COLI-VLM  

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01537614
Other study ID # COLI-VLM
Secondary ID
Status Completed
Phase Phase 1
First received February 17, 2012
Last updated October 10, 2016
Start date October 2011

Study information
Verified date October 2016
Source Poitiers University Hospital
Contact n/a
Is FDA regulated No
Health authority France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study type Interventional

Clinical Trial 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

Recruitment information / eligibility
Status Completed
Enrollment 7
Est. completion date
Est. primary completion date February 2013
Accepts healthy volunteers
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

N/A

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
France Poitiers University Hospital Poitiers

Sponsors (1)
Lead Sponsor Collaborator
Poitiers University Hospital

Country where clinical trial is conducted

France, 

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