Colistin Clinical Trial
— COL-ECMO2022Official title:
Pharmacokinetics of Colistin in Critically Ill Patients With Extracorporeal Membrane Oxygenation
Verified date | January 2024 |
Source | St. Anne's University Hospital Brno, Czech Republic |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Colistin is a lipopeptide antibiotic administered as an inactive prodrug - colistin methanesulfonate (CMS). Colistin is a drug with a narrow therapeutic window; the limiting factors are mainly nephrotoxicity and neurotoxicity dependent on plasma concentrations. The number of patients with these types of infections, as well as the number of patients requiring extracorporeal membrane oxygenation (ECMO) support for severe respiratory failure, increased significantly in association with COVID-19-induced infections. ECMO can generally affect the pharmacokinetics of drugs by creating a new compartment.
Status | Terminated |
Enrollment | 8 |
Est. completion date | January 19, 2024 |
Est. primary completion date | January 19, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 120 Years |
Eligibility | Inclusion Criteria: - Age = 18 years - Men and women (with a negative pregnancy test prior to study enrolment in women of childbearing potential) - Hospitalized at the Department of Anaesthesiology and Resuscitation, St. AnneĀ“s University Hospital Brno - Indication for parenteral colistin (or CMS) as part of standard medical care, i.e., in patients with severe bacterial infection - Informed consent given. In unconscious patients, the study investigator will decide whether to include the patient in the study; this decision is made whenever possible in a medical council consisting of at least one independent physician informed about the study details and one study investigator. An interim informed consent will be given after considering all individual risks. In this case, the Ethics Committee of St. Anne's Hospital in Brno will be informed of the patient's inclusion. The investigator will ask study participants in whom good quality consciousness is restored to give subsequent informed consent without unreasonable delay. Additional inclusion criterion: For some patients (15 individuals are expected), in addition to all the criteria listed in the Eligibility Criteria section, the following inclusion criterion is provided: - ECMO support is needed as part of standard therapy for severe respiratory failure. Exclusion Criteria: - Pregnancy, - Breast-feeding, - Refusal to give the informed consent (primarily or after regaining consciousness). |
Country | Name | City | State |
---|---|---|---|
Czechia | St. Anne's University Hospital Brno | Brno | Czech Republic |
Lead Sponsor | Collaborator |
---|---|
St. Anne's University Hospital Brno, Czech Republic | Palacky University |
Czechia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Verification of the ECMO-induced changes of colistin or CMS area under the plasma concentration versus time curve (AUC) in critically ill patients. | The primary objective of the clinical trial is to determine the area under the plasma concentration versus time curve of colistin and CMS in critically ill patients with and without ECMO during the dosing interval, calculate and compare the area under the plasma concentration versus time curve of CMS and colistin in each group. | 24 hours | |
Secondary | Model of population pharmacokinetics of colistin in critically ill patients - Cmax | To propose a model of population pharmacokinetics of colistin in critically ill patients. The pharmacokinetic model will be designed as a composite of several pharmacokinetics parameters that will be obtained during the individual measurements. The first one is maximum plasma concentrations [Cmax] that will be obtain 2 hours after colistin administration. | 2 hours after colistin administration. The model will be designed through study completion, an average of 1 year | |
Secondary | Model of population pharmacokinetics of colistin in critically ill patients - Tmaxc | To propose a model of population pharmacokinetics of colistin in critically ill patients. The pharmacokinetic model will be designed as a composite of several pharmacokinetics parameters that will be obtained during the individual measurements. The second one is time to maximum plasma concentration (Tmaxc) that will be calculated within 2 hours after colistin administration. | 2 hours after colistin administration. The model will be designed through study completion, an average of 1 year | |
Secondary | Model of population pharmacokinetics of colistin in critically ill patients - Tminc | To propose a model of population pharmacokinetics of colistin in critically ill patients. The pharmacokinetic model will be designed as a composite of several pharmacokinetics parameters that will be obtained during the individual measurements. The third one is time to minimum plasma concentration (Tminc) that will be calculated within 12 hours after colistin administration. | 12 hours after colistin administration. The model will be designed through study completion, an average of 1 year | |
Secondary | Model of population pharmacokinetics of colistin in critically ill patients - Cmin | To propose a model of population pharmacokinetics of colistin in critically ill patients. The pharmacokinetic model will be designed as a composite of several pharmacokinetics parameters that will be obtained during the individual measurements. The fourth one is minimum plasma concentration (Cmin) that will be calculated within 12 hours after colistin administration. | 12 hours after colistin administration. The model will be designed through study completion, an average of 1 year | |
Secondary | Model of population pharmacokinetics of colistin in critically ill patients - AUC | To propose a model of population pharmacokinetics of colistin in critically ill patients. The pharmacokinetic model will be designed as a composite of several pharmacokinetics parameters that will be obtained during the individual measurements. The fifth one is Area Under the Curve (AUC) that will be calculated within 24 hours after colistin administration. | 24 hours after colistin administration. The model will be designed through study completion, an average of 1 year |
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