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.
Přehled studie
Postavení
Podmínky
Detailní popis
Typ studie
Zápis (Aktuální)
Kontakty a umístění
Studijní místa
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Aarhus N
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Aarhus, Aarhus N, Dánsko, 8220
- Department of Infectious Diseases, Aarhus University Hospital
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Metoda odběru vzorků
Studijní populace
Popis
Inclusion Criteria:
- Patients with Cystic Fibrosis, suffering from acute pulmonary exacerbations, treated with continuous infusion of Piperacillin/Tazobactam for a period of two weeks.
Exclusion Criteria:
- Age under 18
Studijní plán
Jak je studie koncipována?
Detaily designu
Kohorty a intervence
Skupina / kohorta |
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Pharmacokinetics Piperacillin
Patients with cystic fibrosis , treated with Piperacillin/Tazobactam, given as continuous infusion for a period of two weeks.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Blood-plasma Concentration of Piperacillin
Časové okno: Piperacillin plasma-concentration was determined 3-5 times for each patient, during the 2 weeks of piperacillin treatment
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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. |
Piperacillin plasma-concentration was determined 3-5 times for each patient, during the 2 weeks of piperacillin treatment
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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The Time Above the Minimum Inhibitory Concentration (T>MIC)
Časové okno: Patients will be followed for the duration of treatment, which is approximately 2 weeks.
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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. |
Patients will be followed for the duration of treatment, which is approximately 2 weeks.
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MIC of Pathogen Detected in Sputum Sample, Prior to Initiation of Treatment.
Časové okno: Sputum sample was collected 3 to 7 days before treatment initiation.
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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.
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Sputum sample was collected 3 to 7 days before treatment initiation.
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Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Ředitel studie: Eskild Petersen, Professor, Department of Infectious Diseases, Aarhus University Hospital, Denmark
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Odhad)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- CF-275-13
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