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

NCT ID: NCT04261348

Last Updated: 2020-09-22

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-02-01
• Study Completion Date: 2022-02-28

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)

Conditions

Antimicrobial Stewardship Program

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Interventions

No intervention

There is no intervention

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

NA

Exclusion Criteria

NA

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Laikο General Hospital, Athens

OTHER

Sponsor Role: lead

Responsible Party

Nikolaos Sipsas

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University Hospital of Laikon

Athens, Attica, Greece

Site Status: RECRUITING

Countries

Greece

Facility Contacts

Nikolaos Sipsas

Role: primary

nsipsas@med.uoa.gr

6974957338

Other Identifiers

59199

Identifier Type: -

Identifier Source: org_study_id