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

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

Study Overview

• Status: Unknown
• Conditions: Surgical Site Infection; Antibiotic Resistant Infection
• Intervention / Treatment: Other: Antibiotic Stewardship Program

Detailed Description

A multicenter time series with segmented regression analysis will be conducted at three national high-volume centers of pancreatic surgery: The General and Pancreatic Surgery Department, Pancreas Institute, of Verona, the Oncological and Robotic General Surgery, Careggi University of Florence, and the Department of Surgery, University Campus Bio-Medico of Rome. All patients visited at the General and Pancreatic Surgery Department, Pancreas Institute, of Verona, the Oncological and Robotic General Surgery, Careggi Hospital, University of Florence, and the Department of Surgery, University Campus Bio-Medico of Rome and scheduled for pancreatic resection will be enrolled. The patients will be submitted to the routinely diagnostic preoperative procedures, including the RS culture, two weeks before surgery. All patients enrolled will receive a preoperative clinical visit two weeks before surgery. During the patient's interview, the surgeon will collect the medical history, exposing the clinical and surgical perioperative pathways. The patient is also submitted to the routinely preoperative lab tests, including the RS. The study design is based on evidence collected by previous studies of the group and after a systematic review of the literature. The 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.

• Study Type: Observational
• Enrollment (Anticipated): 1200

Contacts and Locations

Study Locations

• Italy
  • Verona, Italy, 37124
    • Recruiting
    • AOUI Verona

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All patients visited at the General and Pancreatic Surgery Department, Pancreas Institute, of Verona, the Oncological and Robotic General Surgery, Careggi Hospital, University of Florence, and the Department of Surgery, University Campus Bio-Medico of Rome and scheduled for pancreatic resection will be enrolled. The patients will be submitted to the routinely diagnostic preoperative procedures, including the Rectal Swab culture, two weeks before surgery.

Description

Inclusion Criteria:

• Scheduled for elective pancreatic resection
• Age ≥ 18 years
• American Society of Anesthesiologists (ASA) score < 4
• The ability of the subject to understand the character and individual consequences of the clinical trial
• Written informed consent

Exclusion Criteria:

• Under 18 years of age
• ASA score ≥4
• Immune suppressed patients
• Pregnant women
• Participation in another study with interference of study outcomes
• Impaired mental state or language problems

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
SSI rate after pancreatic surgery	To evaluate the useful of an antimicrobial stewardship program and a patient-tailored antibiotic prophylaxis in the reduction of the occurrence of SSI until 30th day after surgery in patients undergoing pancreatic surgery	30th day after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Antibiotic Stewardship Program in Pancreatic Surgery	To evaluate the useful of an antibiotic stewardship program in the change of the inappropriate use of key antibiotics, such as piperacillin/tazobactam and carbapenems, in administered for prophylaxis or treatment of the SSI	30th day after surgery
Whole genome sequencing of MDR bacteria	To analyze the genotype of the carbapenemase-producing Enterobacteriaceae performing the microbial WGS	30th day after surgery
Treatment costs	To evaluate the useful of an antibiotic stewardship program in the change of the treatment costs	30th day after surgery

Collaborators and Investigators

• Sponsor: Azienda Ospedaliera Universitaria Integrata Verona
• Collaborators: Agenzia Italiana del Farmaco

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 16, 2019
• Primary Completion (ANTICIPATED): September 1, 2022
• Study Completion (ANTICIPATED): December 16, 2022

Study Registration Dates

• First Submitted: December 12, 2019
• First Submitted That Met QC Criteria: December 12, 2019
• First Posted (ACTUAL): December 16, 2019

Study Record Updates

• Last Update Posted (ACTUAL): February 19, 2020
• Last Update Submitted That Met QC Criteria: February 17, 2020
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Disease Attributes; Wound Infection; Infections; Communicable Diseases; Surgical Wound Infection; Anti-Infective Agents; Anti-Bacterial Agents
• Other Study ID Numbers: TRS 2018-00001695

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No