Pharmacokinetics of Piperacillin, Given as Continuous Infusion to Patients With Cystic Fibrosis
At the Department of Infectious Diseases, Aarhus University Hospital, continuous infusion with piperacillin/tazobactam for a period of 2 weeks, has been used for several years in patients with cystic fibrosis, suffering from acute pulmonary exacerbations (APE).
It is an outpatient treatment. To assess the efficacy and quality of the treatment, a blood test every 3rd day is taken to determine the concentration of Piperacillin in blood-plasma.
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||Pharmacokinetics of Piperacillin, Given as Continuous Infusion to Patients With Cystic Fibrosis|
- Blood-plasma Concentration of Piperacillin [ Time Frame: Piperacillin plasma-concentration was determined 3-5 times for each patient, during the 2 weeks of piperacillin treatment ] [ Designated as safety issue: No ]
The free, non-protein bound fraction of plasma piperacillin for each patient was determined using Ultra High Performance Liquid Chromatography. The concentration was compared to the MIC-value (Minimal Inhibitory Concentration) of the pathogen isolated in a sputum sample collected prior to initiation of antibiotic treatment.
Infusion pumps with 16 g of piperacillin per 24 hours were initially used and five patients had piperacillin plasma-concentrations monitored during this treatment regimen. However, in three of these patients, the piperacillin plasma concentrations were unexpectedly low and dropped to a level below the MIC. This was found to be due to antibiotic crystallization within the infusion pumps as a result of the antibiotic concentration being too high. Consequently, infusion pumps with 12 g of piperacillin per 24 hours were used in stead. The median piperaillin concentrations reported below are derived from all measurements within the two weeks of treatment.
- The Time Above the Minimum Inhibitory Concentration (T>MIC) [ Time Frame: Patients will be followed for the duration of treatment, which is approximately 2 weeks. ] [ Designated as safety issue: No ]The time, expressed in percentage, for which the plasma concentration of Piperacillin lies above the minimum inhibitory concentration for the pathogen,during the treatment. If the piperacillin concentration at all measurements during the treatment period was at a level above the MIC, T>MIC is reported as 100%. MIC for the pathogen in sputum was not reported in patient 5. Therefore,T>MIC for this patient could not be estimated.
Biospecimen Retention: Samples Without DNA
|Study Start Date:||July 2013|
|Study Completion Date:||June 2015|
|Primary Completion Date:||June 2015 (Final data collection date for primary outcome measure)|
Patients with cystic fibrosis , treated with Piperacillin/Tazobactam, given as continuous infusion for a period of two weeks.
Patients with cystic fibrosis (CF) are often colonized with multidrug-resistant microorganisms, which increases the risk of suboptimal dosing of antibiotics as the time above the minimum inhibitory concentration (T>MIC) is suboptimal. Continuous infusion of beta-lactam antibiotics is more likely to optimize T>MIC than intermittent infusion. At the Department of Infectious Diseases, Aarhus University Hospital, continuous infusion with piperacillin/tazobactam for a period of 2 weeks, has been used for several years in patients with CF, suffering from acute pulmonary exacerbations (APE). It is an outpatient treatment, and the patients are given 16 g of piperacillin per 24 hours. To assess the efficacy and quality of the treatment, a blood test every 3rd day will be required to monitor the blood-plasma concentration of piperacillin, as well as C-reactive protein (CRP) and white blood cell count (WBC).
Please refer to this study by its ClinicalTrials.gov identifier: NCT01983787
|Department of Infectious Diseases, Aarhus University Hospital|
|Aarhus, Aarhus N, Denmark, 8220|
|Study Director:||Eskild Petersen, Professor||Department of Infectious Diseases, Aarhus University Hospital, Denmark|