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Trial record 45 of 532 for:    VANCOMYCIN

Safety and Efficacy of Vancomycin Plus Beta-lactams (SEVPB)

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ClinicalTrials.gov Identifier: NCT03776409
Recruitment Status : Recruiting
First Posted : December 14, 2018
Last Update Posted : December 27, 2018
Sponsor:
Collaborator:
Second Affiliated Hospital Xi'an Jiaotong University
Information provided by (Responsible Party):
First Affiliated Hospital Xi'an Jiaotong University

Tracking Information
First Submitted Date December 6, 2018
First Posted Date December 14, 2018
Last Update Posted Date December 27, 2018
Actual Study Start Date December 12, 2018
Estimated Primary Completion Date December 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 12, 2018)
  • AKI(acute kidney injury) [ Time Frame: from 24 hours after the start of the combination until discharge up to one month ]
    the incidence of acute kidney injury
  • clinical efficacy [ Time Frame: from 24 hours after the start of the combination until discharge up to one month ]
    microbial eradication
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03776409 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: December 12, 2018)
  • the length of hospital stay [ Time Frame: from hospital admission to discharge up to one month ]
  • duration of AKI [ Time Frame: the time from AKI onset to resolution of AKI up to one month ]
  • onset of AKI [ Time Frame: the first occurence of AKI after starting concomitant antimicrobial use up to one month ]
  • whether renal function return to baseline or not [ Time Frame: from AKI onset to resolution of defined AKI up to one month ]
    whether defined AKI was resoluted or not
  • major acute kidney events at 30 days (MAKE30) [ Time Frame: MAKE30 is assessed 30 days following AKI diagnosis ]
    MAKE30 is assessed 30 days following AKI diagnosis, which is a composite outcome of death, new dialysis, and worsened renal function.
  • vancomycin trough value assessment [ Time Frame: from hospital admission to discharge up to one month ]
    assess the impact of vancomycin exposures on development of AKI
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 Safety and Efficacy of Vancomycin Plus Beta-lactams
Official Title Comparison of the Nephrotoxicity of Vancomycin in Combination With Piperacillin/Tazobactam or Other Beta-lactams in Critically Ill Patients: A Retrospective, Multicenter Study in China
Brief Summary The combination of vancomycin and piperacillin-tazobactam has been associated with an increased risk of acute kidney injury (AKI) in non-critically ill patient populations, but it is still unknown if this association exists in critically ill patients. The objective of this study is to compare AKI and efficacy of vancomycin plus piperacillin-tazobactam or beta-lactams.
Detailed Description

The combination of vancomycin and piperacillin-tazobactam has been associated with an increased risk of acute kidney injury (AKI) in non-critically ill patient populations, but limited data regarding this association exists in critically ill patients. The objective of this study is to compare AKI and efficacy of vancomycin plus piperacillin-tazobactam or beta-lactams.

This is a multicenter, retrospective cohort study. Patients from the retrospective cohort will be divided into 2 groups based on the combination regimen received . Patients who meet the inclusion and exclusion criteria will be included in our registry. As a non-intervention study, these information as below will be collected: basic demographics, diagnosis, concomitant nephrotoxic and other antibiotic medications, serum creatine levels, vancomycin concentrations, and indication for antibiotics.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population critically ill patients
Condition Critical Illness
Intervention
  • Drug: vancomycin plus piperacillin/tazobactam
    Patients in intensive care unit who received the combination of VAN(vancomycin) and PTZ (piperacillin/tazobactam) for at least 48 hours, had a serum creatinine level measured in the 24-hour of hospital admission.The dosage and frequency of VAN and PTZ was adjusted based on clinical practice and patient characteristics.
  • Drug: vancomycin plus other beta-lactams
    Patients in intensive care unit who received the combination of VAN (vancomycin) and other beta-lactams (cefoperazone/sulbactam, meropenem, imipenem/siastatin, ceftriaxone, ceftazidime, et al) for at least 48 hours, had a baseline serum creatinine (Scr) concentration value within 24 hours of hospital admission.The dosage and frequency of VAN and other beta-lactams were adjusted based on clinical practice and patient characteristics.
Study Groups/Cohorts
  • vancomycin plus piperacillin/tazobactam
    Critically ill patients who received the combination of VAN (vancomycin) and PTZ (piperacillin/tazobactam) for at least 48 hours during an ICU (intensive care unit) admission, had a baseline serum creatinine (Scr) concentration value within 24 hours of hospital admission.The dosage and frequency of VAN and PTZ were adjusted based on clinical practice and patient characteristics. This is an observational study without any intervention.
    Intervention: Drug: vancomycin plus piperacillin/tazobactam
  • vancomycin plus other beta-lactams
    Critically ill patients who received the combination of VAN (vancomycin) and other beta-lactams (cefoperazone/sulbactam, meropenem, imipenem/siastatin, ceftriaxone, ceftazidime, et al) for at least 48 hours during an ICU (intensive care unit) admission, had a baseline serum creatinine (Scr) concentration value within 24 hours of hospital admission.The dosage and frequency of VAN and other beta-lactams were adjusted based on clinical practice and patient characteristics. This is an observational study without any intervention.
    Intervention: Drug: vancomycin plus other beta-lactams
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 Recruiting
Estimated Enrollment
 (submitted: December 12, 2018)
1458
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 1, 2019
Estimated Primary Completion Date December 1, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • 18 years or older,
  • admitted to intensive care unit
  • received the combination of vancomycin and beta-lactams for at least 48 hours
  • had a serum creatinine level measured within 24-hour hospital admission
  • had at least one VAN level drawn while receiving a combination of study antibiotics

Exclusion Criteria:

  • pregnancy or lactating patients
  • admission to the intensive care unit during administration or within 72 hours of completing the antibiotics
  • had end-stage renal disease
  • died within 48 hours of combination antibiotic therapy initiation
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Yalin Dong, Ph.D 86-13891800917 dongyalin@mail.xjtu.edu.cn
Contact: Ying Zhang 86-18710451126 xjtuzy941126@stu.xjtu.edu.cn
Listed Location Countries China
Removed Location Countries  
 
Administrative Information
NCT Number NCT03776409
Other Study ID Numbers XJTU1AF2018LSK-169
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party First Affiliated Hospital Xi'an Jiaotong University
Study Sponsor First Affiliated Hospital Xi'an Jiaotong University
Collaborators Second Affiliated Hospital Xi'an Jiaotong University
Investigators
Principal Investigator: Yalin Dong, Ph.D First Affiliated Hospital of Xian Jiaotong University
PRS Account First Affiliated Hospital Xi'an Jiaotong University
Verification Date December 2018