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.

Phase 1

• Conditions: Critically ill patients suffering from hospital infections caused by multi-antibiotic-resistant germs and receiving continuous renal replacement therapy.; MedDRA version: 20.0Level: PTClassification code 10053840Term: Bacterial sepsisSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2021-001019-95-IT
• Lead Sponsor: FONDAZIONE POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI IRCCS UNIVERSITA' CATTOLICA DEL SACRO CUORE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-06-08
• Last Update Posted: 30 August 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

oAge> 18 yy
oDuration of treatment planned for at least 48 hours
oInfection where the involvement of MDR germs is documented or highly probable
oContinuous renal replacement therapy
oAcute renal failure, stage III of the 2012 KDIGO classification
oHalf-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

oState of pregnancy
oRefusal of informed consent
oKnown hypersensitivity to polymyxins
oClinical condition with high probability of death, according to Symplified Acute Physiology Score (SAPS II)
oPartial maintenance of renal function, defined by stages I and II of the 2012 KDIGO classification.
oRenal replacement therapy filter other than AN69 ST 150

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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