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
| NCT number | NCT04261348 |
| Other study ID # | 59199 |
| Secondary ID | |
| Status | Recruiting |
| Phase | |
| First received | |
| Last updated | |
| Start date | February 1, 2020 |
| Est. completion date | February 2022 |
| Verified date | September 2020 |
| Source | Laik? General Hospital, Athens |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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)
| 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 |
| Country | Name | City | State |
|---|---|---|---|
| Greece | University Hospital of Laikon | Athens | Attica |
| Lead Sponsor | Collaborator |
|---|---|
| Laik? General Hospital, Athens |
Greece,
| 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 |