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

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.

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.

Study Overview

• Status: Recruiting
• Conditions: Critically Ill; Multi-antibiotic Resistance; Hospital Infection
• Intervention / Treatment: Drug: Colistin

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Phase 4

Contacts and Locations

Study Locations

• Italy
  • Italia
    • Roma, Italia, Italy, 00168
      • Recruiting
      • Fondazione Policlinico A.Gemelli IRCSS
      • Contact: Margherita Zona; Phone Number: +390630155701; Email: margherita.zona@policlinicogemelli.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Colistin Arm; Intravenous administration of 6.75 x 106 Units Colistin for 30 minutes	Drug: Colistin; intravenous administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Area under the plasma concentration versus time curve (AUC)	Colistin A and B misuration in the plasma and in the pre-post filter.	0-12 hours
Peak plasma concentration	Colistin A and B misuration in the plasma	0-12 hours
Half-life	Colistin A and B misuration in the plasma	0-12 hours

Collaborators and Investigators

• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Study record dates

Study Major Dates

• Study Start (Actual): July 14, 2021
• Primary Completion (Anticipated): January 30, 2022
• Study Completion (Anticipated): January 30, 2022

Study Registration Dates

• First Submitted: July 23, 2021
• First Submitted That Met QC Criteria: August 2, 2021
• First Posted (Actual): August 6, 2021

Study Record Updates

• Last Update Posted (Actual): August 6, 2021
• Last Update Submitted That Met QC Criteria: August 2, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: Colistin
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Iatrogenic Disease; Infections; Communicable Diseases; Critical Illness; Cross Infection; Anti-Infective Agents; Anti-Bacterial Agents; Colistin
• Other Study ID Numbers: 3946

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No