NEW_SAFE: Study to Optimize the Use of New Antibiotics

Sponsor

Fundación Pública Andaluza para la gestión de la Investigación en Sevilla (Other)

Overall Status

Recruiting

CT.gov ID

NCT03941951

Collaborator

(none)

900

Enrollment

Locations

Arms

41.8

Anticipated Duration (Months)

64.3

Patients Per Site

1.5

Patients Per Site Per Month

Study Details

Study Description

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:

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.
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.
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.

Condition or Disease	Intervention/Treatment	Phase
Bacterial Infections Fungal Infection	Behavioral: Non-impositive Program for Optimizing the Use of Antimicrobials	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

900 participants

Allocation:

Non-Randomized

Intervention Model:

Sequential Assignment

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.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.

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jul 9, 2019

Anticipated Primary Completion Date :

Dec 31, 2020

Anticipated Study Completion Date :

Dec 31, 2022

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Total antibiotic consumption [Yearly from date of intervention up to 24 months of follow-up]
Defined daily doses (DDD) of each antibiotic per 1000 stays

Secondary Outcome Measures

Total cost per antimicrobial [Yearly from date of intervention up to 24 months of follow-up]
Total expense in euros of each antimicrobial per 1000 stays
Mortality rate [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.
Total length of hospital stay [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.
Incidence of colitis due to Clostridium difficile. [Monthly from date of intervention up to 24 months of follow-up]
Clostridium difficile infection documented during treatment with any of the antibiotics described
Percentage of patients with infections by multiresistant microorganisms. Colonization during treatment by resistant microorganisms [Monthly from date of intervention up to 24 months of follow-up]
Percentage of patients with infections by multiresistant microorganisms in each cohort.
Percentage of patients colonized by multiresistant microorganisms [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.
Re-admission rate [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	Country
1	Hospital de Poniente-El Ejido	Almería	Spain
2	University Hospital Puerta del Mar	Cadiz	Spain
3	University Hospital Reina Sofía	Córdoba	Spain
4	Hospital Clínico Universitario San Cecilio	Granada	Spain
5	University Hospital Virgen de las Nieves	Granada	Spain
6	Área Hospitalaria Juan Ramón Jiménez	Huelva	Spain
7	Complejo Hospitalario de Jaén	Jaén	Spain
8	University Hospital de Jerez de la Frontera	Jerez De La Frontera	Spain
9	Hospital Regional Universitario de Málaga	Málaga	Spain
10	University Hospital Virgen de la Victoria	Málaga	Spain
11	Hospital de Puerto Real	Puerto Real	Spain
12	University Hospital Virgen de Valme	Sevilla	Spain
13	University Hospital Virgen del Rocío	Sevilla	Spain
14	University Hospital Virgen Macarena (Sevilla).	Sevilla	Spain