Study to Optimize the Use of New Antibiotics (NEW_SAFE)

Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

Status: Unknown

Conditions: Fungal Infection; Bacterial Infections

Treatments: Behavioral: Non-impositive Program for Optimizing the Use of Antimicrobials

Study type: Interventional

Funder types: Other

Identifiers

NCT03941951

FIS-TED-2019-01

Details and patient eligibility

About

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.

Enrollment: 900 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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900 participants in 3 patient groups

Pre-intervention Cohort

No Intervention group

Description:

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.

Intervention cohort

Other group

Description:

Cohort of patients with complex infections treated with ceftaroline, tedizolid, dalbavancin, ceftazidime-avibactam, ceftolozane-tazobactam or isavuconazole from January 2010 to June 2021.

Treatment:

Behavioral: Non-impositive Program for Optimizing the Use of Antimicrobials

Safety cohort

No Intervention group

Description:

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.