Study to Optimize the Use of New Antibiotics (NEW_SAFE)

May 28, 2020 updated by: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

Quasi-experimental Intervention Study to Optimize the Use of New Antibiotics (Project NEW_SAFE)

Quasi-experimental intervention multicenter trial of patients treated with new antibiotics (before-after study).

The study will be carried out in 14 hospitals of the Andalusian Public Health System with representation from all the provinces and has been designed in two phases:

  1. A first phase in which an observational study of historical preintervention cohorts of patients who have received either empirical or targeted treatment with ceftaroline, tedizolid, dalbavancin, ceftazidime-avibactam, ceftolozane-tazobactam and isavuconazole from January 2016 to December 2019 will be developed. Case detection will be carried out by locating the antimicrobial prescriptions in the electronic prescribing systems and / or pharmaceutical management systems of each hospital. A set of epidemiological, clinical, microbiological and prognostic variables will be completed in each case.
  2. A second phase or intervention period that will be applied to the cohort of patients treated with new antibiotics (intervention cohort) from January 2020 to June 2021. A quasi-experimental intervention study will be carried out through the development of a Program for Optimizing the use of Antibiotics (PROA) in Spanish, Antimicrobial Stewardship Program (ASP) in English, in the participating hospitals. It will consist in the development of a consensus document on the use of new antibiotics following a Delphi methodology, dissemination of the consensus document / guide among the participating hospitals and audit on the prescription of new antimicrobials after the implementation of the guide based on providing non-imposition advice and positive reinforcement to the prescriber. The recommendations will be consigned in a structured form, which will allow to evaluate the degree of follow-up of the recommendations. The audit will be performed on day 0-1 of the prescription.
  3. Cohort of bacteremia due to multiresistant microorganisms ("safety" cohort): In order to evaluate the safety of the use of new antimicrobials against therapeutic alternatives in syndromes where they are potentially a preferred option and parallel to the two phases, episodes for bacteremia by carbapenem-resistant Acinetobacter baumannii and Pseudomonas aeruginosa, carbapenem-resistant enterobacteria, vancomycin-resistant Enterococcus faecium and methicillin-resistant Staphylococcus aureus occurred in participating hospitals from 2017 to 2021 will be collected.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

900

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Spain
      • Almería, Spain
        • Suspended
        • Hospital de Poniente-El Ejido
      • Cadiz, Spain
      • Córdoba, Spain
        • Recruiting
        • University Hospital Reina Sofia
        • Contact:
      • Granada, Spain
        • Recruiting
        • Hospital Clinico Universitario San Cecilio
        • Contact:
      • Granada, Spain
      • Huelva, Spain
        • Recruiting
        • Area Hospitalaria Juan Ramón Jimenez
        • Contact:
      • Jaén, Spain
      • Jerez De La Frontera, Spain
        • Recruiting
        • University Hospital de Jerez de la Frontera
      • Málaga, Spain
        • Recruiting
        • Hospital Regional Universitario de Málaga
        • Sub-Investigator:
          • Ignacio Márquez Gómez
      • Málaga, Spain
        • Recruiting
        • University Hospital Virgen de la Victoria
        • Contact:
      • Puerto Real, Spain
      • Sevilla, Spain
        • Recruiting
        • University Hospital Virgen del Rocio
        • Contact:
      • Sevilla, Spain
        • Recruiting
        • University Hospital Virgen de Valme
      • Sevilla, Spain
        • Recruiting
        • University Hospital Virgen Macarena (Sevilla).
        • Contact:
        • Principal Investigator:
          • Zaira R Palacios Baena
        • Principal Investigator:
          • Pilar Retamar Gentil
        • Sub-Investigator:
          • Natalia A Maldonado Lizarazo
        • Sub-Investigator:
          • Lorena López Cerero
        • Sub-Investigator:
          • Adoración Valiente
        • Sub-Investigator:
          • Margarita Beltrán

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Pre-intervention cohort (historical):

Inclusion criteria:

  • All patients treated with ceftaroline, tedizolid, dalbavancin, ceftazidime-avibactam, ceftolozane-tazobactam or isavuconazole.
  • In a hospital or ambulatory regime.
  • That they have received at least 1 dose of treatment of any of the antimicrobials mentioned, either as empirical or directed treatment.
  • Adults (18 years).
  • Between January 1, 2016 and December 31, 2019.

Exclusion criteria:

• There are no exclusion criteria except for age.

Intervention cohort:

Inclusion criteria:

  • All patients treated with ceftaroline, tedizolid, dalbavancin, ceftazidime-avibactam, ceftolozane-tazobactam or isavuconazole.
  • In a hospital or ambulatory regime.
  • That they have received at least 1 dose of treatment of any of the antimicrobials mentioned, either as empirical or directed treatment.
  • Adults (18 years).
  • From January 1, 2020 to December 31, 2021.
  • Since the publication and diffusion of the recommendation guide.

Exclusion criteria:

• There are no exclusion criteria except for age.

Safety cohort:

Inclusion criteria:

  • All episodes of clinically significant bacteremia (that have received any treatment) produced by:
  • Acinetobacter baumannii resistant or with intermediate susceptibility to any carbapenem.
  • Pseudomonas aeruginosa resistant or with intermediate susceptibility to any carbapenem.
  • Enterobacteria resistant or with intermediate susceptibility to any carbapenem.
  • Vancomycin-resistant Enterococcus faecium.
  • Methicillin-resistant Staphylococcus aureus.
  • From January 1, 2017 to December 31, 2021.
  • Adult patients (18 years old).

Exclusion criteria:

• There are no exclusion criteria except for age.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SEQUENTIAL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: Pre-intervention Cohort
Cohort of patients who have received either empirical or targeted treatment with ceftaroline, tedizolid, dalbavancin, ceftazidime-avibactam, ceftolozane-tazobactam or isavuconazole from January 2016 to December 2019 will be included.
OTHER: Intervention cohort
Cohort of patients with complex infections treated with ceftaroline, tedizolid, dalbavancin, ceftazidime-avibactam, ceftolozane-tazobactam or isavuconazole from January 2010 to June 2021.
Behavioral: Non-impositive Program for Optimizing the Use of Antimicrobials
Quasi-experimental intervention through the development of a Program for Optimizing the Use of Antimicrobials in the participating hospitals. The intervention will consist of the development of a consensus guide on the use of new antibiotics, its dissemination in Andalusian hospitals and an audit on the prescription of new antibiotics.
NO_INTERVENTION: Safety cohort
Cohort of patients with bacteremia due to carbapenem-resistant Acinetobacter baumannii and Pseudomonas aeruginosa, carbapenem-resistant enterobacteria, vancomycin-resistant Enterococcus faecium and methicillin-resistant Staphylococcus aureus occurred in participating hospitals from 2017 to 2021 will be collected.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total antibiotic consumption
Time Frame: Yearly from date of intervention up to 24 months of follow-up
Defined daily doses (DDD) of each antibiotic per 1000 stays
Yearly from date of intervention up to 24 months of follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total cost per antimicrobial
Time Frame: Yearly from date of intervention up to 24 months of follow-up
Total expense in euros of each antimicrobial per 1000 stays
Yearly from date of intervention up to 24 months of follow-up
Mortality rate
Time Frame: At 7, 14 and 30 days after the start of the treatment.
Mortality from any cause at 7, 14 and 30 days after the start of the treatment.
At 7, 14 and 30 days after the start of the treatment.
Total length of hospital stay
Time Frame: Monthly from date of intervention up to 24 months of follow-up
Duration of a single episode of hospitalization defined as the time between hospital admission and discharge measured in days. During this episode the patient has to be prescribed with one of the antibiotics included in the study.
Monthly from date of intervention up to 24 months of follow-up
Incidence of colitis due to Clostridium difficile.
Time Frame: Monthly from date of intervention up to 24 months of follow-up
Clostridium difficile infection documented during treatment with any of the antibiotics described
Monthly from date of intervention up to 24 months of follow-up
Percentage of patients with infections by multiresistant microorganisms. Colonization during treatment by resistant microorganisms
Time Frame: Monthly from date of intervention up to 24 months of follow-up
Percentage of patients with infections by multiresistant microorganisms in each cohort.
Monthly from date of intervention up to 24 months of follow-up
Percentage of patients colonized by multiresistant microorganisms
Time Frame: Monthly from date of intervention up to 24 months of follow-up
Percentage of patients colonized by multiresistant microorganisms in each cohort after completion of treatment with antibiotic under study.
Monthly from date of intervention up to 24 months of follow-up
Re-admission rate
Time Frame: 90 days after the start of the antibiotic treatment.
Re-admission of the patient in the hospital at 90 days after the start of the antibiotic treatment.
90 days after the start of the antibiotic treatment.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

Investigators

  • Principal Investigator: Zaira Palacios Baena, University Hospital Virgen Macarena

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 9, 2019

Primary Completion (ANTICIPATED)

December 31, 2020

Study Completion (ANTICIPATED)

December 31, 2022

Study Registration Dates

First Submitted

April 4, 2019

First Submitted That Met QC Criteria

May 7, 2019

First Posted (ACTUAL)

May 8, 2019

Study Record Updates

Last Update Posted (ACTUAL)

June 1, 2020

Last Update Submitted That Met QC Criteria

May 28, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FIS-TED-2019-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Bacterial Infections

Clinical Trials on Non-impositive Program for Optimizing the Use of Antimicrobials

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Saudi Arabia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe