Effects of an Antimicrobial Stewardship (AMS) Program, on the Prevalence of Multidrug-resistant Gram - Negative Pathogens, in an Area of High Consumption of Antibiotics and High Resistance Rates

• Conditions: Antimicrobial Stewardship Program

• Registration Number: NCT04261348
• Lead Sponsor: Laikο General Hospital, Athens

Brief Summary

1. To evaluate the long-term effect of the AMS program on the consumption of broad-spectrum antibiotics and on the consumption of antibiotics in general (sustainability of the efficacy of the program). More specifically, the investigators shall examine the consumption of protected antibiotics during the years 2019 - 2020 and they shall compare it with the consumption of antibiotics before the implementation of the AMS program.

2. To evaluate the impact of the AMS program, combined with an infection control program, on the incidence of MDRGN infections in a hospital with high MDR incidence. Confounding factors are a barrier to analyze the impact of ASPs on antibiotic resistance. In a hospital setting, one of the most important confounding factors is the implementation of infection control practices at the same time as the ASPs. It is extremely difficult to infer causality between an ASP and antibiotic resistance reduction when infection control is a confounding factor, especially if the study intervention combines an ASP and infection control practices performed at the same time. The way to go around the problem is to implement ASP and IC at different time points. The investigators implemented the ASP program in September 2015 and they added the IC program in September 2018. Therefore, the investigators shall be able to compare the two-time periods (i.e. ASP alone vs. ASP/IC) by using the time series analysis and delineate the impact of each intervention.

3. To evaluate the effect of the AMS program on patient outcomes (in-hospital mortality, length of stay)

Detailed Description

Not available

Study Timeline

• Study Start: 2020-02-01
• Study First Submitted: 2020-02-04
• Study First Submitted QC: 2020-02-06
• Study First Posted: 2020-02-07
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-21
• Last Update Posted: 2020-09-22
• Primary Completion: 2021-12
• Study Completion: 2022-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

NA

Exclusion Criteria

NA

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Days of antibiotics	2 yars	days of antibiotics (number of days)
Consumption of antibiotics	2 years	consumption of antimicrobials (defined daily doses / 100 patient-days)
Length of stay	2 years	length of stay (number of days)
Days of therapy	2 years	days of therapy for each drug (number of days)
Patients receiving surgical prophylaxis	2 years	percentage of patients receiving appropriate surgical prophylaxis
Clinical cure rate	2 years	clinical cure rate of the initial antibiotic regimen (%)
Hospital mortality rate	2 years	in-hospital mortality rate (%)

Trial Locations

Locations (1)

University Hospital of Laikon; 🇬🇷 Athens, Attica, Greece