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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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04261348
Enrollment
500
Registered
2020-02-07
Start date
2020-02-01
Completion date
2022-02-28
Last updated
2020-09-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Antimicrobial Stewardship Program

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)

Interventions

OTHERNo intervention

There is no intervention

Sponsors

Laikο General Hospital, Athens
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

NA

Exclusion criteria

NA

Design outcomes

Primary

MeasureTime frameDescription
Consumption of antibiotics2 yearsconsumption of antimicrobials (defined daily doses / 100 patient-days)
Days of therapy2 yearsdays of therapy for each drug (number of days)
Days of antibiotics2 yarsdays of antibiotics (number of days)
Patients receiving surgical prophylaxis2 yearspercentage of patients receiving appropriate surgical prophylaxis
Hospital mortality rate2 yearsin-hospital mortality rate (%)
Clinical cure rate2 yearsclinical cure rate of the initial antibiotic regimen (%)
Length of stay2 yearslength of stay (number of days)

Countries

Greece

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 17, 2026