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

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)

Study Overview

• Status: Unknown
• Conditions: Antimicrobial Stewardship Program
• Intervention / Treatment: Other: No intervention

• Study Type: Observational
• Enrollment (Anticipated): 500

Contacts and Locations

Study Locations

• Greece
  • Attica
    • Athens, Attica, Greece, 11527
      • Recruiting
      • University Hospital of Laikon
      • Contact: Nikolaos Sipsas; Phone Number: 6974957338; Email: nsipsas@med.uoa.gr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

All patients who will be administered antibiotics

Description

Inclusion Criteria:

NA

Exclusion Criteria:

NA

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Laikο General Hospital, Athens

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2020
• Primary Completion (Anticipated): December 1, 2021
• Study Completion (Anticipated): February 1, 2022

Study Registration Dates

• First Submitted: February 4, 2020
• First Submitted That Met QC Criteria: February 6, 2020
• First Posted (Actual): February 7, 2020

Study Record Updates

• Last Update Posted (Actual): September 22, 2020
• Last Update Submitted That Met QC Criteria: September 21, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: 59199

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