- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02134665
Unexpected Pharmacokinetics of Vancomycin in Patients With Severe Acute Pancreatitis Compared With Pneumonia
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Forventet)
Kontakter og lokationer
Studiesteder
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Shanghai
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Shanghai, Shanghai, Kina, 200025
- Rekruttering
- Ruijin Hospital
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Kontakt:
- He
- Telefonnummer: 662618 86-21-64370045
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion Criteria:
- age 18-85years old
- vancomycin use ≥ 3days
Exclusion Criteria:
- age <18years old or >85 years old
- vancomycin use < 3days
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
|---|
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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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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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vancomycin serum trough concentrations in these patients just prior to the next vancomycin serum trough concentrations was measured
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
the pharmacokinetic parameters was calculated using the Bayesian estimator.
Tidsramme: patients will be followed for the duration of hospital stay, an expected average of 5 weeks
|
patients will be followed for the duration of hospital stay, an expected average of 5 weeks
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Studieleder: Wan-Hua Yang, Prof., Ruijin Hospital
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- hejuanwin19811119
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