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

Colistin use in Cystic Fibrosis patients: pharmacokinetic studies (intravenous administration) in relation with pharmacodynamics, tolerance profile and risk of selection of resistance.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-004987-80-BE

Enrollment

100

Registered

2014-02-18

Start date

2014-08-28

Completion date

Unknown

Last updated

2025-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

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 COMPO

Eligibility

Sex/Gender

All

Inclusion 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

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

Design outcomes

Primary

Measure	Time frame
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.;Secondary Objective: 1) Prospectively evaluating the safety and the profile tolerance of colistin in adult CF patients;Primary end point(s): not applicable;Timepoint(s) of evaluation of this end point: not applicable	—

Measure

Time frame

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.;Secondary Objective: 1) Prospectively evaluating the safety and the profile tolerance of colistin in adult CF patients;Primary end point(s): not applicable;Timepoint(s) of evaluation of this end point: not applicable

—

Secondary

Measure	Time frame
Secondary end point(s): not applicable;Timepoint(s) of evaluation of this end point: not applicable	—

Countries

Belgium

Contacts

Public ContactDr Wellemans Isabelle

CUB - Hôpital Erasme

isabelle.wellemans@erasme.ulb.ac.be003225558111

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026