- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT02134665
Unexpected Pharmacokinetics of Vancomycin in Patients With Severe Acute Pancreatitis Compared With Pneumonia
Studieöversikt
Status
Betingelser
Detaljerad beskrivning
The purpose of this study was to evaluate the influence of severe acute pancreatitis on the serum level of vancomycin, a glycopeptide antibacterial agent.
After reviewing more than 6000 clinical charts of patients who received vancomycin therapy and whose serum vancomycin level was monitored between January 2010 and December 2013, we identified 212 patients who also had diagnosed as severe acute pancreatitis (SAP group), and 98 patients who also had diagnosed as pneumonia (pneumonia group) at that time. The fluorescence polarization immunoassay method was used to measure vancomycin serum trough concentrations in these patients 30 min before the next administration. Using these measurements, we calculated the pharmacokinetic parameters using the Bayesian estimator.
Studietyp
Inskrivning (Förväntat)
Kontakter och platser
Studieorter
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Shanghai
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Shanghai, Shanghai, Kina, 200025
- Rekrytering
- Ruijin Hospital
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Kontakt:
- He
- Telefonnummer: 662618 86-21-64370045
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
Inclusion Criteria:
- age 18-85years old
- vancomycin use ≥ 3days
Exclusion Criteria:
- age <18years old or >85 years old
- vancomycin use < 3days
Studieplan
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
|---|
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severe acute pancreatitis
patients who received vancomycin therapy and whose serum vancomycin level was monitored, and who also had diagnosed as severe acute pancreatitis.
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Pneumonia
patients who received vancomycin therapy and whose serum vancomycin level was monitored, and who also had diagnosed as pneumonia.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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vancomycin serum trough concentrations in these patients just prior to the next vancomycin serum trough concentrations was measured
Tidsram: patients will be followed for the duration of hospital stay, an expected average of 5 weeks
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vancomycin serum trough concentrations was measured in patients just prior to the next dose at steady-state conditions (approximately after the fourth dose).
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patients will be followed for the duration of hospital stay, an expected average of 5 weeks
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Sekundära resultatmått
Resultatmått |
Tidsram |
|---|---|
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the pharmacokinetic parameters was calculated using the Bayesian estimator.
Tidsram: patients will be followed for the duration of hospital stay, an expected average of 5 weeks
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patients will be followed for the duration of hospital stay, an expected average of 5 weeks
|
Samarbetspartners och utredare
Sponsor
Utredare
- Studierektor: Wan-Hua Yang, Prof., Ruijin Hospital
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Förväntat)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- hejuanwin19811119
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