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Unexpected Pharmacokinetics of Vancomycin in Patients With Severe Acute Pancreatitis Compared With Pneumonia

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ClinicalTrials.gov Identifier: NCT02134665
Recruitment Status : Unknown
Verified May 2014 by He Juan, Ruijin Hospital.
Recruitment status was:  Recruiting
First Posted : May 9, 2014
Last Update Posted : May 9, 2014
Sponsor:
Information provided by (Responsible Party):
He Juan, Ruijin Hospital

Tracking Information
First Submitted Date January 24, 2014
First Posted Date May 9, 2014
Last Update Posted Date May 9, 2014
Study Start Date May 2013
Actual Primary Completion Date May 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 7, 2014)
vancomycin serum trough concentrations in these patients just prior to the next vancomycin serum trough concentrations was measured [ Time Frame: patients will be followed for the duration of hospital stay, an expected average of 5 weeks ]
vancomycin serum trough concentrations was measured in patients just prior to the next dose at steady-state conditions (approximately after the fourth dose).
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: May 7, 2014)
the pharmacokinetic parameters was calculated using the Bayesian estimator. [ Time Frame: patients will be followed for the duration of hospital stay, an expected average of 5 weeks ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Unexpected Pharmacokinetics of Vancomycin in Patients With Severe Acute Pancreatitis Compared With Pneumonia
Official Title Unexpected Pharmacokinetics of Vancomycin in Patients With Severe Acute Pancreatitis Compared With Pneumonia
Brief Summary The purpose of this study was to evaluate the influence of severe acute pancreatitis on the serum level of vancomycin, a glycopeptide antibacterial agent.
Detailed Description

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.

Study Type Observational
Study Design Observational Model: Case Control
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population patients who used vancomycin and who had diagnosed as severe acute pancreatitis (SAP group), and patients who had diagnosed as pneumonia (pneumonia group) . meanwhile, the fluorescence polarization immunoassay method was used to measure vancomycin serum trough concentrations in these patients 30 min before the next administration.
Condition Arbitrary Restriction Polymorphism 1
Intervention Not Provided
Study Groups/Cohorts
  • severe acute pancreatitis
    patients who received vancomycin therapy and whose serum vancomycin level was monitored, and who also had diagnosed as severe acute pancreatitis.
  • Pneumonia
    patients who received vancomycin therapy and whose serum vancomycin level was monitored, and who also had diagnosed as pneumonia.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: May 7, 2014)
200
Original Estimated Enrollment Same as current
Estimated Study Completion Date May 2014
Actual Primary Completion Date May 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • age 18-85years old
  • vancomycin use ≥ 3days

Exclusion Criteria:

  • age <18years old or >85 years old
  • vancomycin use < 3days
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries China
Removed Location Countries  
 
Administrative Information
NCT Number NCT02134665
Other Study ID Numbers hejuanwin19811119
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party He Juan, Ruijin Hospital
Study Sponsor Ruijin Hospital
Collaborators Not Provided
Investigators
Study Director: Wan-Hua Yang, Prof. Ruijin Hospital
PRS Account Ruijin Hospital
Verification Date May 2014