NCT05586438

Pharmacokinetics of Colistin in Critically-ill Patients With AKI Who Receive SLED

Pharmacokinetics of Colistin in Critically-ill Patients With Acute Kidney Injury Who Receive Sustained Low-Efficiency Dialysis
Mahidol University·Phase 4·ClinicalTrials.gov·drugCompleted
View on ClinicalTrials.gov
Study focus
Disease/Condition
Bacterial Infections
Drug/Device/Intervention
Colistin Sulfomethate
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
Mahidol University
Location
Bangkok, Thailand
Timeline & enrollment
Phase
Phase 4
Start date
Oct 18, 2021
End date
Oct 31, 2022
Enrollment
13 participants
Primary outcome

Area under the concentration-time curve [AUC],Maximum Plasma Concentration [Cmax]

Summary

Colistin was developed in the 1960s and preliminary pharmacokinetic studies were performed at
 that time. Dosing recommendations, on the basis of these pharmacokinetic studies, are listed
 in the drug's product information. However, there are no optimal dosing recommendations for
 patients with acute kidney injury who receive sustained low-efficiency dialysis. Furthermore,
 the science of antibiotic dosing (pharmacodynamics) has changed significantly since the
 1960s and it is quite possible that the dosing recommendations listed in the product
 information are not optimal. Furthermore, even though physicians refer to colistin
 administration, the only intravenous form of the drug is colistin methanesulfonate (CMS). CMS
 is converted in the body to colistin. Both CMS and colistin have different pharmacokinetic
 and antimicrobial activities. For this reason, we, the investigators at the Mahidol
 university, are performing a pharmacokinetic study of the intravenous CMS/colistin in
 patients requiring sustained low-efficiency dialysis. Plasma concentrations will be
 determined around a CMS/colistin dose once the drug has reached steady state. Microbiologic
 and clinical endpoints will be determined and will be correlated with these concentrations.
 The measurement of CMS and colistin levels will be determined by a laboratory in Australia.

ICD-10 classifications
Bacterial infection, unspecifiedBacterial, viral and other infectious agentsOther bacterial intestinal infectionsOther bacterial diseasesOther specified bacterial intestinal infections
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT05586438
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT05586438 through Pure Global AI's free database. This Phase 4 trial is sponsored by Mahidol University and is currently Completed. The study focuses on Bacterial Infections. Target enrollment is 13 participants.

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