AzTrials
AzTrials

Antimicrobial Stewardship ProgramNCT04261348

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

An observational study of Antimicrobial Stewardship Program, run by Laikο General Hospital, Athens at 1 site in Greece.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

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). Read more about this study

Who is it for?
Any age
Conditions the study is for
Antimicrobial Stewardship Program
How many people
500 participants
Where
1 siteGreece
Study dates
1 Feb 2020to Feb 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: All patients who will be administered antibiotics

Who may be able to join

  • NA

Who cannot join

  • NA

Trial locations and contacts

1 site in 1 country.

Greece1 site, 1 recruiting

  • University Hospital of Laikon

    Athens, Attica, 11527

    Nikolaos Sipsas, 6974957338, nsipsas@med.uoa.gr

    Recruiting

Other trials in Greece

About this study

  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)
Being tested
No intervention

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • No interventionOther

    There is no intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Consumption of antibiotics

    consumption of antimicrobials (defined daily doses / 100 patient-days)

    Measured: 2 years

  2. Days of therapy

    days of therapy for each drug (number of days)

    Measured: 2 years

  3. Days of antibiotics

    days of antibiotics (number of days)

    Measured: 2 yars

  4. Patients receiving surgical prophylaxis

    percentage of patients receiving appropriate surgical prophylaxis

    Measured: 2 years

  5. Hospital mortality rate

    in-hospital mortality rate (%)

    Measured: 2 years

  6. Clinical cure rate

    clinical cure rate of the initial antibiotic regimen (%)

    Measured: 2 years

  7. Length of stay

    length of stay (number of days)

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Feb 2020
  2. Study start1 Feb 2020
  3. Primary completionDec 2021 (estimated)
  4. Study completionFeb 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
500 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04261348
Sponsor's protocol ID
59199
Status last verified
Sep 2020
First submitted
4 Feb 2020
Last updated
22 Sep 2020
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Samarkos M, Markogiannakis A, Deliolanis J, Pantazis N, Apostolidi EA, Gamaletsou MN, Psychogiou M, Daikos GL, Sipsas NV. Effect of an antibiotic stewardship program on antimicrobial use and resistance in a high prescribing, high resistance setting: A single-center, interrupted time series analysis. Eur J Clin Microbiol Infect Dis. 2026 Sep 15. doi: 10.1007/s10096-026-05671-6. Online ahead of print.

    PubMed 42742921

Questions about this trial

What is this clinical trial studying?

An observational study of Antimicrobial Stewardship Program, run by Laikο General Hospital, Athens at 1 site in Greece.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 22 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Consumption of antibiotics (time frame: 2 years). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04261348, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2020.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in