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

Arbitrary Restriction Polymorphism 1 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02134665
• Other study ID #: hejuanwin19811119
• Status: Recruiting
• Phase: N/A
• First received: January 24, 2014
• Last updated: May 7, 2014
• Start date: May 2013
• Est. completion date: May 2014

Study information

• Verified date: May 2014
• Source: Ruijin Hospital
• Contact: Juan He
• Phone: 86-21-64370045
• Email: hejuanwin[@]126.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• age 18-85years old

• vancomycin use = 3days

Exclusion Criteria:

• age <18years old or >85 years old

• vancomycin use < 3days

Study Design

Observational Model: Case Control, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Arbitrary Restriction Polymorphism 1
• Pancreatitis

Locations

Country	Name	City	State
China	Ruijin Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Ruijin Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	vancomycin serum trough concentrations in these patients just prior to the next vancomycin serum trough concentrations was measured	vancomycin serum trough concentrations was measured in patients just prior to the next dose at steady-state conditions (approximately after the fourth dose).	patients will be followed for the duration of hospital stay, an expected average of 5 weeks	No
Secondary	the pharmacokinetic parameters was calculated using the Bayesian estimator.		patients will be followed for the duration of hospital stay, an expected average of 5 weeks	No