Metabolisation and efficiency study of colistin in critically ill patients

Colistin use in critically ill patients: pharmacokinetic population and pharmacodynamic studies, tolerance profil and risk of selection of resistance

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-003708-22-BE

Enrollment

Registered

2015-09-14

Start date

2015-10-23

Completion date

Unknown

Last updated

2025-02-17

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

Conditions

Patients in intensive care unit suffering of infection by multi-drug resistance bacteria treated by colistin MedDRA version: 18.0 Level: HLT Classification code 10040054 Term: Sepsis, bacteraemia, viraemia and fungaemia NEC System Organ Class: 100000004862

Interventions

Trade Name: COLISTINEB Product Name: colistineb Pharmaceutical Form: Powder for solution for infusion

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: -age > 18 years -infection by multidrug resistant Gram negative bacteria -treatment by 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 20 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 40

Exclusion criteria

Exclusion criteria: -age < 18 years -pregnant or breast feeding

Design outcomes

Primary

Measure	Time frame
Main Objective: 1)Prospectively evaluating the pharmacokinetics and pharmacodynamics of colistin in critically ill patients infected by multidrug resistant Gram negative bacteria 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 ;Secondary Objective: Prospectively evaluating the safety and the profile tolerance of colistin in critically ill 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 critically ill patients infected by multidrug resistant Gram negative bacteria 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 ;Secondary Objective: Prospectively evaluating the safety and the profile tolerance of colistin in critically ill 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 ContactCotton Frederic

Hospital Erasme

fcotton@ulb.ac.be003225553702

Outcome results

None listed

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