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

Antimicrobial Stewardship Program Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04261348
• Other study ID #: 59199
• Status: Recruiting
• Start date: February 1, 2020
• Est. completion date: February 2022

Study information

• Verified date: September 2020
• Source: Laik? General Hospital, Athens
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: February 2022
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

NA

Exclusion Criteria:

NA

Related Conditions & MeSH terms

• Antimicrobial Stewardship Program

Intervention

Other:
• No intervention
There is no intervention

Locations

Country	Name	City	State
Greece	University Hospital of Laikon	Athens	Attica

Sponsors (1)

Lead Sponsor	Collaborator
Laik? General Hospital, Athens

Country where clinical trial is conducted

Greece, 

Outcome

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