Pharmacokinetics of Piperacillin, Given as Continuous Infusion to Patients With Cystic Fibrosis
|ClinicalTrials.gov Identifier: NCT01983787|
Recruitment Status : Completed
First Posted : November 14, 2013
Results First Posted : October 1, 2015
Last Update Posted : December 11, 2015
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.
|Condition or disease||Phase|
|Cystic Fibrosis||Phase 4|
|Study Type :||Observational|
|Actual Enrollment :||10 participants|
|Official Title:||Pharmacokinetics of Piperacillin, Given as Continuous Infusion to Patients With Cystic Fibrosis|
|Study Start Date :||July 2013|
|Primary Completion Date :||June 2015|
|Study Completion Date :||June 2015|
U.S. FDA Resources
Patients with cystic fibrosis , treated with Piperacillin/Tazobactam, given as continuous infusion for a period of two weeks.
- 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 ]
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. ]
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.
Patient 1-5 were treated with piperacillin 16g/day. Patient 6-10 were treated with piperacillin 12g/day.
- MIC of Pathogen Detected in Sputum Sample, Prior to Initiation of Treatment. [ Time Frame: Sputum sample was collected 3 to 7 days before treatment initiation. ]MIC to piperacillin/tazobactam was obtained by using E-tests (AB Biodisk, Solna, Sweden) on Mueller-Hinton agar plates incubated at 35 ± 2 degrees Celcius with inoculum, incubation time and atmosphere in accordance to the E-test application guide.
Biospecimen Retention: Samples Without DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|