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Antibiotic Stewardship Program in Pancreatic Surgery: a Multicenter Time Series Analysis (BIOSTEPS).

NCT04199494 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 1200

Last updated 2020-02-19

No results posted yet for this study

Summary

Rationale: Surgical site infection (SSI) is one of the most frequently reported postoperative complication, occurring in up to one-third of patients. Its development causes a substantial increase in the clinical and economic burden of pancreatic surgery. Nowadays, the primary goal of a surgical department is the reduction of the SSI rate, based on a cautious approach to the prescription of the antibiotic prophylaxis (AP) to avoid the spread of multi-drug resistant (MDR) bacteria. An antimicrobial stewardship program and a patient-tailored antibiotic prophylaxis could be an optimal strategy to reduce the impact of infectious complications after pancreatic surgery. However, few data are available regarding this topic.

Objective: To evaluate the useful of an antimicrobial stewardship program and a patient-tailored antibiotic prophylaxis in the reduction of the occurrence of SSI and the inappropriate use of key antibiotics in patients undergoing pancreatic surgery.

Study design: A time series study will be conducted. The antimicrobial stewardship program is shared between three national high-volume centers of pancreatic surgery. Statistical significance and effect size were calculated by segmented regression analysis of interrupted time series of drug use, SSI rate, and costs for 3 years before and after the introduction of the program.

Study population: Patients with an indication for elective pancreatic surgery.

Main study parameters/endpoints: Primary outcome is the reduction of SSI rate. Secondary outcomes are the reduction of the use of the key antibiotics (such as piperacillin/tazobactam and carbapenems), the microbial whole-genome sequencing (WGS) of the carbapenemase-producing Enterobacteriaceae, and the reduction of the treatment costs

Conditions

  • Surgical Site Infection
  • Antibiotic Resistant Infection

Interventions

OTHER

Antibiotic Stewardship Program

The patient do the routinely preoperative lab tests, including the rectal swab (RS). The Antibiotic Stewardship Program (ASP) has been shown to effectively reduce unnecessary antibiotic use and optimize the treatment of infectious diseases. To be successful, multiple aspects should be considered in the ASP. Initially, the infection control specialists will follow the routine activity of each department in order to define what could immediately be improved. Internal antibiotic prophylaxis and therapy guidelines will be defined and shared between groups. The RS, collected at the preoperative testing, is evaluated by the infection control specialist. In case of identification of MDR bacteria, each patient will receive a tailored AP based on the antibiograms of the RS. In any case, the infection control specialist will choose the best solution for the patient avoiding the key antibiotics

Sponsors & Collaborators

  • Agenzia Italiana del Farmaco

    collaborator OTHER_GOV

  • Azienda Ospedaliera Universitaria Integrata Verona

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-12-16
Primary Completion
2022-09-01
Completion
2022-12-16

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04199494 on ClinicalTrials.gov