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

NCT04261348 | Unknown

• 1 other identifier: 59199
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Antimicrobial Stewardship Program

Outcome Measures

Primary Outcomes (7)

• 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

Interventions

No intervention OTHER

There is no intervention

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All patients who will be administered antibiotics

Sponsors & Collaborators

• Laikο General Hospital, Athens: lead

Study Sites (1)

University Hospital of Laikon

Athens, Attica, 11527, Greece

RECRUITING

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 4, 2020
• First Posted: February 7, 2020
• Study Start: February 1, 2020
• Primary Completion: December 1, 2021
• Study Completion: February 1, 2022
• Last Updated: September 22, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)