Clinical trial NCT03941951: Study to Optimize the Use of New Antibiotics
Official title: Quasi-experimental Intervention Study to Optimize the Use of New Antibiotics (Project NEW_SAFE)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Bacterial Infections
Fungal Infection
Keywords: Quasi-experimental study
Multidrug resistant bacteria
Antimicrobial stewardship
Ceftaroline
Tedizolid
Dalbavancin
Ceftazidime-avibactam
Ceftolozane-tazobactam
Isavuconazole
Lead sponsor: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Sponsor class: OTHER
First posted: 2019-05-08
Enrollment: 900
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: The prescribers are assigned to receive the intervention if they have prescribed any of the antibiotics ceftaroline, tedizolid, dalbavancin, ceftazidime-avibactam, ceftolozane-tazobactam or isavuconazole from January 2010 to June 2021.
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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.

Primary outcomes:
measure: Total antibiotic consumption
timeFrame: Yearly from date of intervention up to 24 months of follow-up
Secondary outcomes:
measure: Total cost per antimicrobial
timeFrame: Yearly from date of intervention up to 24 months of follow-up
measure: Mortality rate
timeFrame: At 7, 14 and 30 days after the start of the treatment.
measure: Total length of hospital stay
timeFrame: Monthly from date of intervention up to 24 months of follow-up
measure: Incidence of colitis due to Clostridium difficile.
timeFrame: Monthly from date of intervention up to 24 months of follow-up
measure: Percentage of patients with infections by multiresistant microorganisms. Colonization during treatment by resistant microorganisms
timeFrame: Monthly from date of intervention up to 24 months of follow-up
measure: Percentage of patients colonized by multiresistant microorganisms
timeFrame: Monthly from date of intervention up to 24 months of follow-up
measure: Re-admission rate
timeFrame: 90 days after the start of the antibiotic treatment.
Other outcomes:
Locations:
city: Almería
country: Spain
facility: Hospital de Poniente-El Ejido
city: Cadiz
country: Spain
facility: University Hospital Puerta del Mar
city: Córdoba
country: Spain
facility: University Hospital Reina Sofía
city: Granada
country: Spain
facility: Hospital Clínico Universitario San Cecilio
city: Granada
country: Spain
facility: University Hospital Virgen de las Nieves
city: Huelva
country: Spain
facility: Área Hospitalaria Juan Ramón Jiménez
city: Jaén
country: Spain
facility: Complejo Hospitalario de Jaén
city: Jerez De La Frontera
country: Spain
facility: University Hospital de Jerez de la Frontera
city: Málaga
country: Spain
facility: Hospital Regional Universitario de Málaga
city: Málaga
country: Spain
facility: University Hospital Virgen de la Victoria
city: Puerto Real
country: Spain
facility: Hospital de Puerto Real
city: Sevilla
country: Spain
facility: University Hospital Virgen de Valme
city: Sevilla
country: Spain
facility: University Hospital Virgen del Rocío
city: Sevilla
country: Spain
facility: University Hospital Virgen Macarena (Sevilla).
Study officials:
affiliation: University Hospital Virgen Macarena
name: Zaira Palacios Baena
role: PRINCIPAL_INVESTIGATOR
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