Pharmacokinetic/pharmacodynamic aspects of colistin intravenous administration in critically ill patients suffering from hospital infections caused by multi-antibiotic-resistant germs and receiving continuous renal replacement therapy.

Pharmacokinetic/pharmacodynamic aspects of colistin intravenous administration in critically ill patients suffering from hospital infections caused by multi-antibiotic-resistant germs and receiving continuous renal replacement therapy. - COLIMICINA

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2021-001019-95-IT

Enrollment

Registered

2021-06-08

Start date

2021-05-31

Completion date

Unknown

Last updated

2024-10-28

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

Conditions

Critically ill patients suffering from hospital infections caused by multi-antibiotic-resistant germs and receiving continuous renal replacement therapy. MedDRA version: 20.0 Level: PT Classification code 10053840 Term: Bacterial sepsis System Organ Class: 10021881 - Infections and infestations

Interventions

Product Name: COLIMICINA Product Code: [COLIMICINA] Pharmaceutical Form: Powder and solvent for solution for injection/infusion INN or Proposed INN: COLIMICINA CAS Number: 1264-72-8 Current Sponsor co

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: o Age> 18 yy o Duration of treatment planned for at least 48 hours o Infection where the involvement of MDR germs is documented or highly probable o Continuous renal replacement therapy o Acute renal failure, stage III of the 2012 KDIGO classification o Half-life of the continuous renal replacement therapy filter less than 48 hours. 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 15 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 5

Exclusion criteria

Exclusion criteria: o State of pregnancy o Refusal of informed consent o Known hypersensitivity to polymyxins o Clinical condition with high probability of death, according to Symplified Acute Physiology Score (SAPS II) o Partial maintenance of renal function, defined by stages I and II of the 2012 KDIGO classification. o Renal replacement therapy filter other than AN69 ST 150

Design outcomes

Primary

Measure	Time frame
Main Objective: Primary objective. Describe the pharmacokinetic and pharmacodynamic profile of colistin, determining the drug levels in the plasma compartment of critically ill patients admitted to intensive care, suffering from serious infections that require the use of this drug as well as continuous renal replacement therapy.;Secondary Objective: Secondary objectives. In addition, we will evaluate: 1) the extent of colistin removal by continuous renal replacement therapy, 2) the clinical and microbiological response, 3) the emergence of resistant pathogens, 4) the rate of Clostridium difficile infections and 5) any fungal colonization.;Primary end point(s): Colimycin plasma levels after IV infusion;Timepoint(s) of evaluation of this end point: 0 - 12 hours	—

Measure

Time frame

Main Objective: Primary objective. Describe the pharmacokinetic and pharmacodynamic profile of colistin, determining the drug levels in the plasma compartment of critically ill patients admitted to intensive care, suffering from serious infections that require the use of this drug as well as continuous renal replacement therapy.;Secondary Objective: Secondary objectives. In addition, we will evaluate: 1) the extent of colistin removal by continuous renal replacement therapy, 2) the clinical and microbiological response, 3) the emergence of resistant pathogens, 4) the rate of Clostridium difficile infections and 5) any fungal colonization.;Primary end point(s): Colimycin plasma levels after IV infusion;Timepoint(s) of evaluation of this end point: 0 - 12 hours

—

Countries

Italy

Contacts

Public ContactDIREZIONE SCIENTIFICA

FONDAZIONE POLICLINICO UNIVERSITARIO A. GEMELLI IRCCS

MARGHERITA.ZONA@POLICLINICOGEMELLI.IT0630155701

Outcome results

None listed

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