Bacterial Infections Clinical Trial
Official title:
Pharmacokinetics of Colistin in Critically-ill Patients With Acute Kidney Injury Who Receive Sustained Low-Efficiency Dialysis
Verified date | November 2022 |
Source | Mahidol University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 13 |
Est. completion date | October 31, 2022 |
Est. primary completion date | October 31, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 95 Years |
Eligibility | Inclusion Criteria: - Males or females greater than 18 years of age. - All patients will remain in the hospital for pharmacokinetic sampling. - All subjects must be on the medication colistin as part of their standard of care. - All subjects must be on sustained low-efficiency dialysis Exclusion Criteria: - Pregnancy and lactation - The patients receiving colistin inhalation |
Country | Name | City | State |
---|---|---|---|
Thailand | Faculty of Medicine Siriraj Hospital, Mahidol University | Bangkok |
Lead Sponsor | Collaborator |
---|---|
Mahidol University | Monash University |
Thailand,
Jitmuang A, Nation RL, Koomanachai P, Chen G, Lee HJ, Wasuwattakul S, Sritippayawan S, Li J, Thamlikitkul V, Landersdorfer CB. Extracorporeal clearance of colistin methanesulphonate and formed colistin in end-stage renal disease patients receiving intermittent haemodialysis: implications for dosing. J Antimicrob Chemother. 2015;70(6):1804-11. doi: 10.1093/jac/dkv031. Epub 2015 Feb 18. — View Citation
Nation RL, Garonzik SM, Thamlikitkul V, Giamarellos-Bourboulis EJ, Forrest A, Paterson DL, Li J, Silveira FP. Dosing guidance for intravenous colistin in critically-ill patients. Clin Infect Dis. 2017 Mar 1;64(5):565-571. doi: 10.1093/cid/ciw839. Epub 2016 Dec 23. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Area under the concentration-time curve [AUC] | The area under the plasma drug concentration-time curve (AUC) reflects the actual body exposure to colistin after administration of a dose of colistin and is expressed in mg*h/L. Predose, and 1, 2, 5, 8, 12 hours after administration |
24 hours | |
Primary | Maximum Plasma Concentration [Cmax] | Cmax is the maximum (or peak) serum concentration that colistin achieves in a specified compartment or test area of the body after colistin has been administered and before the administration of a second dose. Predose, and 1, 2, 5, 8, 12 hours after administration. |
24 hours | |
Secondary | Treatment-Related Adverse Events CTCAE v4.0 | Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0 | 14 days |
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