Study to Optimize the Use of New Antibiotics

NCT ID: NCT03941951

Last Updated: 2020-06-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

900 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-09

Study Completion Date

2022-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Bacterial Infections Fungal Infection

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

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 Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type OTHER

Non-impositive Program for Optimizing the Use of Antimicrobials

Intervention Type BEHAVIORAL

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.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.


* 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.


* 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

Intervention cohort:



Safety cohort:
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Zaira Palacios Baena

Role: PRINCIPAL_INVESTIGATOR

University Hospital Virgen Macarena

Locations

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Hospital de Poniente-El Ejido

Almería, , Spain

Site Status SUSPENDED

University Hospital Puerta del Mar

Cadiz, , Spain

Site Status RECRUITING

University Hospital Reina Sofía

Córdoba, , Spain

Site Status RECRUITING

Hospital Clínico Universitario San Cecilio

Granada, , Spain

Site Status RECRUITING

University Hospital Virgen de las Nieves

Granada, , Spain

Site Status RECRUITING

Área Hospitalaria Juan Ramón Jiménez

Huelva, , Spain

Site Status RECRUITING

Complejo Hospitalario de Jaén

Jaén, , Spain

Site Status RECRUITING

University Hospital de Jerez de la Frontera

Jerez de la Frontera, , Spain

Site Status RECRUITING

Hospital Regional Universitario de Málaga

Málaga, , Spain

Site Status RECRUITING

University Hospital Virgen de la Victoria

Málaga, , Spain

Site Status RECRUITING

Hospital de Puerto Real

Puerto Real, , Spain

Site Status RECRUITING

University Hospital Virgen de Valme

Seville, , Spain

Site Status RECRUITING

University Hospital Virgen del Rocío

Seville, , Spain

Site Status RECRUITING

University Hospital Virgen Macarena (Sevilla).

Seville, , Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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Zaira Palacios Baena

Role: CONTACT

34 653276353

Pilar Retamar Gentil

Role: CONTACT

600162313

Facility Contacts

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Andrés Martín Aspas

Role: primary

Juan José Castón Osorio

Role: primary

Francisco Anguita Santos

Role: primary

Pilar Aznarte Padial

Role: primary

Francisco Javier Martinez Marcos

Role: primary

Carmen Herrero Rodríguez

Role: primary

Salvador López Cárdenas

Role: primary

Lucía Valiente De Santis

Role: primary

Guillermo Gonzalo Ojeda Burgos

Role: primary

Patricia Jimenez Aguilar

Role: primary

Juan E Corzo Delgado

Role: primary

Julia M Praena Segovia

Role: primary

Zaira Palacios

Role: primary

References

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Other Identifiers

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FIS-TED-2019-01

Identifier Type: -

Identifier Source: org_study_id

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