Colistin Clinical Trial
Official title:
Evaluation of Steady-state Pharmacokinetic and Pharmacodynamic Properties of Intravenous Colistimethate Sodium in Cystic Fibrosis and Critically Ill Patients
NCT number | NCT02288429 |
Other study ID # | 13-2597 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | September 2013 |
Est. completion date | June 2019 |
Verified date | June 2019 |
Source | University of Colorado, Denver |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Colistin is a polymixin antibiotic used in the treatment of multidrug-resistant gram-negative infections. Given the limited use of colistin and previous challenges with laboratory assays to determine plasma concentrations, there is a lack of knowledge of the pharmacokinetic profile of colistin. The purpose of the investigators observational prospective pharmacokinetic cohort study is to examine the steady-state pharmacokinetic and pharmacodynamic properties of intravenous colistimethate sodium in cystic fibrosis and critically ill patients.
Status | Completed |
Enrollment | 16 |
Est. completion date | June 2019 |
Est. primary completion date | June 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 89 Years |
Eligibility |
Inclusion Criteria: - Patients = 18 years old receiving intravenous colistimethate sodium for the treatment of infection - Have cystic fibrosis and/or are critically ill (admitted to a critical care unit) Exclusion Criteria: - Pregnancy - Breastfeeding - Prisoners |
Country | Name | City | State |
---|---|---|---|
United States | University of Colorado Hospital | Aurora | California |
Lead Sponsor | Collaborator |
---|---|
University of Colorado, Denver |
United States,
Imberti R, Cusato M, Villani P, Carnevale L, Iotti GA, Langer M, Regazzi M. Steady-state pharmacokinetics and BAL concentration of colistin in critically Ill patients after IV colistin methanesulfonate administration. Chest. 2010 Dec;138(6):1333-9. doi: 10.1378/chest.10-0463. Epub 2010 Jun 17. — View Citation
Karnik ND, Sridharan K, Jadhav SP, Kadam PP, Naidu RK, Namjoshi RD, Gupta V, Gore MS, Surase PV, Mehta PR, Gogtay JA, Thatte UM, Gogtay NJ. Pharmacokinetics of colistin in critically ill patients with multidrug-resistant Gram-negative bacilli infection. Eur J Clin Pharmacol. 2013 Jul;69(7):1429-36. doi: 10.1007/s00228-013-1493-9. Epub 2013 Mar 19. — View Citation
Landman D, Georgescu C, Martin DA, Quale J. Polymyxins revisited. Clin Microbiol Rev. 2008 Jul;21(3):449-65. doi: 10.1128/CMR.00006-08. Review. — View Citation
Li J, Coulthard K, Milne R, Nation RL, Conway S, Peckham D, Etherington C, Turnidge J. Steady-state pharmacokinetics of intravenous colistin methanesulphonate in patients with cystic fibrosis. J Antimicrob Chemother. 2003 Dec;52(6):987-92. Epub 2003 Oct 29. — View Citation
Markou N, Markantonis SL, Dimitrakis E, Panidis D, Boutzouka E, Karatzas S, Rafailidis P, Apostolakos H, Baltopoulos G. Colistin serum concentrations after intravenous administration in critically ill patients with serious multidrug-resistant, gram-negative bacilli infections: a prospective, open-label, uncontrolled study. Clin Ther. 2008 Jan;30(1):143-51. doi: 10.1016/j.clinthera.2008.01.015. — View Citation
Plachouras D, Karvanen M, Friberg LE, Papadomichelakis E, Antoniadou A, Tsangaris I, Karaiskos I, Poulakou G, Kontopidou F, Armaganidis A, Cars O, Giamarellou H. Population pharmacokinetic analysis of colistin methanesulfonate and colistin after intravenous administration in critically ill patients with infections caused by gram-negative bacteria. Antimicrob Agents Chemother. 2009 Aug;53(8):3430-6. doi: 10.1128/AAC.01361-08. Epub 2009 May 11. — View Citation
Ratjen F, Rietschel E, Kasel D, Schwiertz R, Starke K, Beier H, van Koningsbruggen S, Grasemann H. Pharmacokinetics of inhaled colistin in patients with cystic fibrosis. J Antimicrob Chemother. 2006 Feb;57(2):306-11. Epub 2006 Jan 5. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Number of patients experiencing neurotoxicity | Neurotoxicity (headache, dizziness, weakness, facial and peripheral paresthesia, vertigo, visual disturbances, confusion, ataxia, and neuromuscular blockade, or other central nervous system related symptoms) as determined by patient report | Baseline, during colistin therapy course (expected to be approximately 14 days), and until hospital discharge (participants will be followed for the duration of hospital stay, expected to be 2-4 weeks) | |
Primary | Area under the plasma concentration time curve (AUC0-24) | Steady-state plasma concentrations will be obtained after at least 2 days of therapy. Blood draws (5 ml) will be taken just before the start of the colistimethate sodium infusion and at 30, 60, 120, 240, and 360 minutes after the IV infusion. | 0, 30, 60, 120, 240, and 360 minutes after the IV infusion | |
Secondary | Number of patients experiencing nephrotoxicity | Nephrotoxicity defined as either 1) a rise in serum creatinine (SCr) > or = 0.5 mg/dl; 2) 50% increase in SCr or 3) 25% decrease in estimated creatinine clearance | Baseline, during colistin therapy course (expected to be approximately 14 days), and until hospital discharge (participants will be followed for the duration of hospital stay, expected to be 2-4 weeks) |
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