Colistin dosage through blood samples and sputum in Cystic Fibrosis (CF) population

• Register: EUCTR
• Last refreshed on: 7 October 2014
• Main ID: EUCTR2013-004987-80-BE
• Date of registration: 18/02/2014
• Prospective Registration: Yes
• Primary sponsor: CUB - Hôpital Erasme
• Public title: Colistin dosage through blood samples and sputum in Cystic Fibrosis (CF) population
• Scientific title: Colistin use in Cystic Fibrosis patients: pharmacokinetic studies (intravenous administration) in relation with pharmacodynamics, tolerance profile and risk of selection of resistance.
• Date of first enrolment: 28/08/2014
• Recruitment status: Authorised-recruitment may be ongoing or finished
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2013-004987-80
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: no Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no

Countries of recruitment

Belgium

Contacts

• Name: Dr Wellemans Isabelle
• Affiliation: CUB - Hôpital Erasme

• Name: Dr Wellemans Isabelle
• Affiliation: CUB - Hôpital Erasme

Key inclusion & exclusion criteria

Inclusion criteria:
1. CF patients aged of > 18 years
2. BMI > 18 kg/m2,
3. P. aeruginosa positive exacerbations,
4. requiring IV antibiotics including colistin
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 100
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
1. chronic renal insufficiency,
2. pregnancy or lactation,
3. no IV antibiotics in the month prior to inclusion.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

Colistin use in Cystic Fibrosis patients
MedDRA version: 16.1 Level: PT Classification code 10011762 Term: Cystic fibrosis System Organ Class: 10010331 - Congenital, familial and genetic disorders

Intervention(s)

Trade Name: COLISTINEB 2MUI
Pharmaceutical Form: Powder for solution for injection/infusion
INN or Proposed INN: Colistineb
CAS Number: 8068-28-8
Other descriptive name: COLISTIMETHATE SODIUM (A COMPONENT)
Concentration unit: million IU million international units
Concentration type: equal
Concentration number: 2-

Primary Outcome(s)

Main Objective: 1) Prospectively evaluating the pharmacokinetics and pharmacodynamics of colistin in adult CF patients infected by multidrug resistant P. aeruginosa in order to propose algorithms for optimizing doses in this patients' population
2) Studying in vitro the pharmacodynamics of colistin activity against clinical isolates from the same patients when grown as biofilms as well as the conditions of drug exposure favoring selection of resistance in vitro.

Primary end point(s): not applicable

Secondary Objective: 1) Prospectively evaluating the safety and the profile tolerance of colistin in adult CF patients

Timepoint(s) of evaluation of this end point: not applicable

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: not applicable

Secondary end point(s): not applicable

Secondary ID(s)

2013-Colistin

Source(s) of Monetary Support

CUB - Hôpital Erasme