Colistin Intravenous Administration in Critically Ill Patients Suffering From Hospital Infections Caused by Multi-antibiotic-resistant Germs.

Institute of Hospitalization and Scientific Care (IRCCS)

Status and phase

Unknown

Phase 4

Conditions

Critically Ill

Multi-antibiotic Resistance

Hospital Infection

Treatments

Drug: Colistin

Study type

Interventional

Funder types

Other

Identifiers

NCT04995133

3946

Details and patient eligibility

About

Colistin is an antibiotic active against several classes of multi-resistant gram-negative bacteria; the drug should be used in high doses in patients on continuous renal replacement therapy, since the drug is eliminated through the dialysis filter.

This is an Open-label, Phase 4, interventional, prospective, single-center pilot study aimed to analyze the concentrations of colistin in plasma and ultrafiltrate by liquid chromatography/mass spectrometry, in 20 critically ill patients admitted to intensive care and suffering from severe infections by multi-resistant bacteria, who receive continuous renal replacement therapy.

Enrollment

20 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Infection where the involvement of MDR germs is documented or highly probable
Continuous renal replacement therapy
Acute renal failure, stage III of the 2012 KDIGO classification
Half-life of the continuous renal replacement therapy filter less than 48 hours.

Exclusion criteria

State of pregnancy or breastfeeding, or patients expecting to conceive children within the projected duration of the study, starting with the screening through 30 days after the last dose of IMP treatment
Patients with a positive urine pregnancy test within 72 hours prior to study drug treatment. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required. In the event that 72 hours have elapsed between the screening pregnancy test and the first dose of study treatment, another pregnancy test (urine or serum) must be performed and must be negative in order for subject to start receiving study medication
Women of childbearing potential
Refusal of informed consent
Known hypersensitivity to polymyxins and to excipients
Clinical condition with high probability of death, according to Symplified Acute Physiology Score (SAPS II)
Partial maintenance of renal function, defined by stages I and II of the 2012 KDIGO classification.
Renal replacement therapy filter other than AN69 ST 150
Prior systemic treatments with any investigational agents within 4 weeks prior to the inclusion in the trial
Any other clinical condition that, in the opinion of the investigator, makes the patient unfit for the trial