Back to resultsColistin Intravenous Administration in Critically Ill Patients Suffering From Hospital Infections Caused by Multi-antibiotic-resistant Germs.
Primary Purpose
Hospital Infection, Multi-antibiotic Resistance, Critically Ill
Status
Unknown status
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
Colistin
Sponsored by
About this trial
This is an interventional treatment trial for Hospital Infection focused on measuring Colistin
Eligibility Criteria
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
Sites / Locations
- Fondazione Policlinico A.Gemelli IRCSSRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Colistin Arm
Arm Description
Intravenous administration of 6.75 x 106 Units Colistin for 30 minutes
Outcomes
Primary Outcome Measures
Area under the plasma concentration versus time curve (AUC)
Colistin A and B misuration in the plasma and in the pre-post filter.
Peak plasma concentration
Colistin A and B misuration in the plasma
Half-life
Colistin A and B misuration in the plasma
Secondary Outcome Measures
Full Information
NCT ID
NCT04995133
First Posted
July 23, 2021
Last Updated
August 2, 2021
Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
1. Study Identification
Unique Protocol Identification Number
NCT04995133
Brief Title
Colistin Intravenous Administration in Critically Ill Patients Suffering From Hospital Infections Caused by Multi-antibiotic-resistant Germs.
Official Title
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.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Unknown status
Study Start Date
July 14, 2021 (Actual)
Primary Completion Date
January 30, 2022 (Anticipated)
Study Completion Date
January 30, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hospital Infection, Multi-antibiotic Resistance, Critically Ill
Keywords
Colistin
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Colistin Arm
Arm Type
Experimental
Arm Description
Intravenous administration of 6.75 x 106 Units Colistin for 30 minutes
Intervention Type
Drug
Intervention Name(s)
Colistin
Intervention Description
intravenous administration
Primary Outcome Measure Information:
Title
Area under the plasma concentration versus time curve (AUC)
Description
Colistin A and B misuration in the plasma and in the pre-post filter.
Time Frame
0-12 hours
Title
Peak plasma concentration
Description
Colistin A and B misuration in the plasma
Time Frame
0-12 hours
Title
Half-life
Description
Colistin A and B misuration in the plasma
Time Frame
0-12 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Fondazione Policlinico A.Gemelli IRCSS
City
Roma
State/Province
Italia
ZIP/Postal Code
00168
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Margherita Zona
Phone
+390630155701
Email
margherita.zona@policlinicogemelli.it
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Colistin Intravenous Administration in Critically Ill Patients Suffering From Hospital Infections Caused by Multi-antibiotic-resistant Germs.
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