|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
24 October 2016 |
|
Main ID: |
NCT01537614 |
|
Date of registration:
|
17/02/2012 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Pharmacokinetic Study of Aerosolized Colimycin in Cystic Fibrosis
COLI-VLM |
|
Scientific title:
|
|
|
Date of first enrolment:
|
October 2011 |
|
Target sample size:
|
7 |
|
Recruitment status: |
Completed |
|
URL:
|
https://clinicaltrials.gov/show/NCT01537614 |
|
Study type:
|
Interventional |
|
Study design:
|
N/A
|
|
Phase:
|
Phase 1
|
|
|
Countries of recruitment
|
|
France
| | | | | | | |
|
Key inclusion & exclusion 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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Cystic Fibrosis
|
|
Intervention(s)
|
|
Drug: COLIMYCINE inhalation
|
|
Drug: COLIMYCINE injectable
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|