NCT04995133

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jul 2021

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 14, 2021

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

July 23, 2021

Completed
14 days until next milestone

First Posted

Study publicly available on registry

August 6, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2022

Completed
Last Updated

August 6, 2021

Status Verified

August 1, 2021

Enrollment Period

7 months

First QC Date

July 23, 2021

Last Update Submit

August 2, 2021

Conditions

Hospital InfectionMulti-antibiotic ResistanceCritically Ill

Keywords

Colistin

Outcome Measures

Primary Outcomes (3)

  • 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

Study Arms (1)

Colistin Arm

EXPERIMENTAL

Intravenous administration of 6.75 x 106 Units Colistin for 30 minutes

Drug: Colistin

Interventions

ColistinDRUG

intravenous administration

Colistin Arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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
  • Any other clinical condition that, in the opinion of the investigator, makes the patient unfit for the trial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fondazione Policlinico A.Gemelli IRCSS

Roma, Italia, 00168, Italy

RECRUITING

Related Publications (1)

  • De Pascale G, Lisi L, Cutuli SL, Marinozzi C, Palladini A, Ferrando ES, Tanzarella ES, Lombardi G, Grieco DL, Caroli A, Xhemalaj R, Cascarano L, Ciotti GMP, Sandroni C, Sanguinetti M, Navarra P, Antonelli M. High-dose colistin pharmacokinetics in critically ill patients receiving continuous renal replacement therapy. Ann Intensive Care. 2024 Sep 28;14(1):152. doi: 10.1186/s13613-024-01384-1.

    PMID: 39340688DERIVED

MeSH Terms

Conditions

Cross InfectionCritical Illness

Interventions

Colistin

Condition Hierarchy (Ancestors)

InfectionsIatrogenic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PolymyxinsPeptides, CyclicMacrocyclic CompoundsPolycyclic CompoundsLipopeptidesLipidsAntimicrobial Cationic PeptidesPeptidesAmino Acids, Peptides, and ProteinsAntimicrobial PeptidesPore Forming Cytotoxic ProteinsMembrane ProteinsProteins

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 23, 2021

First Posted

August 6, 2021

Study Start

July 14, 2021

Primary Completion

January 30, 2022

Study Completion

January 30, 2022

Last Updated

August 6, 2021

Record last verified: 2021-08

Locations

IT(1)