Study to Optimize the Use of New Antibiotics

NCT03941951 | Unknown DMC

• 1 other identifier: FIS-TED-2019-01
• Study Type: interventional
• Target: 900
• Locations: 1 country
• Sites: 14

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. 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. 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. 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.

Conditions

Bacterial Infections; Fungal Infection

Keywords

Quasi-experimental study; Multidrug resistant bacteria; Antimicrobial stewardship; Ceftaroline; Tedizolid; Dalbavancin; Ceftazidime-avibactam; Ceftolozane-tazobactam; Isavuconazole

Outcome Measures

Primary Outcomes (1)

• Total antibiotic consumption

  Defined daily doses (DDD) of each antibiotic per 1000 stays

  Yearly from date of intervention up to 24 months of follow-up

Secondary Outcomes (7)

• Total cost per antimicrobial

  Yearly from date of intervention up to 24 months of follow-up

• Mortality rate

  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

• Incidence of colitis due to Clostridium difficile.

  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

  Monthly from date of intervention up to 24 months of follow-up

Study Arms (3)

Pre-intervention Cohort

NO INTERVENTION

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

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

Safety cohort

NO INTERVENTION

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.

Interventions

Non-impositive Program for Optimizing the Use of Antimicrobials 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.

Intervention cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Intervention cohort:
• 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.
• Safety cohort:
• 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.

Sponsors & Collaborators

• Fundación Pública Andaluza para la gestión de la Investigación en Sevilla: lead

Study Sites (14)

Hospital de Poniente-El Ejido

Almería, Spain

SUSPENDED

University Hospital Puerta del Mar

Cadiz, Spain

RECRUITING

University Hospital Reina Sofía

Córdoba, Spain

RECRUITING

Hospital Clínico Universitario San Cecilio

Granada, Spain

RECRUITING

University Hospital Virgen de las Nieves

Granada, Spain

RECRUITING

Área Hospitalaria Juan Ramón Jiménez

Huelva, Spain

RECRUITING

Complejo Hospitalario de Jaén

Jaén, Spain

RECRUITING

University Hospital de Jerez de la Frontera

Jerez de la Frontera, Spain

RECRUITING

Hospital Regional Universitario de Málaga

Málaga, Spain

RECRUITING

University Hospital Virgen de la Victoria

Málaga, Spain

RECRUITING

Hospital de Puerto Real

Puerto Real, Spain

RECRUITING

University Hospital Virgen de Valme

Seville, Spain

RECRUITING

University Hospital Virgen del Rocío

Seville, Spain

RECRUITING

University Hospital Virgen Macarena (Sevilla).

Seville, Spain

RECRUITING

Related Publications (35)

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  BACKGROUND

• Rodriguez-Bano J, Pano-Pardo JR, Alvarez-Rocha L, Asensio A, Calbo E, Cercenado E, Cisneros JM, Cobo J, Delgado O, Garnacho-Montero J, Grau S, Horcajada JP, Hornero A, Murillas-Angoiti J, Oliver A, Padilla B, Pasquau J, Pujol M, Ruiz-Garbajosa P, San Juan R, Sierra R; GEIH-SEIMC; SEFH; SEMPSPH. [Programs for optimizing the use of antibiotics (PROA) in Spanish hospitals: GEIH-SEIMC, SEFH and SEMPSPH consensus document]. Farm Hosp. 2012 Jan-Feb;36(1):33.e1-30. doi: 10.1016/j.farma.2011.10.001. Epub 2011 Dec 1. Spanish.

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• Programa integral de prevención y control de las infecciones relacionadas con la asistencia sanitaria y uso apropiado de los antimicrobianos (PIRASOA). pirasoa.iavante.es/

  BACKGROUND

• European Centre for Disease Prevention and Control. Rapid risk assessment: Carbapenem-resistant Enterobacteriaceae - first update 4 June 2018. Stockholm: ECDC; 2018. https://ecdc.europa.eu/sites/portal/files/documents/RRA-Enterobacteriaceae-Carbapenems-European-Union-countries.pdf

  BACKGROUND

• Lopez-Cerero L, Egea P, Gracia-Ahufinger I, Gonzalez-Padilla M, Rodriguez-Lopez F, Rodriguez-Bano J, Pascual A. Characterisation of the first ongoing outbreak due to KPC-3-producing Klebsiella pneumoniae (ST512) in Spain. Int J Antimicrob Agents. 2014 Dec;44(6):538-40. doi: 10.1016/j.ijantimicag.2014.08.006. Epub 2014 Sep 26.

  PMID: 25446907 BACKGROUND

• PIRASOA: actividad laboratorio de referencia. Accesible en: pirasoa.iavante.es/mod/resource/view.php?id=797

  BACKGROUND

• Rodriguez-Bano J, Gutierrez-Gutierrez B, Machuca I, Pascual A. Treatment of Infections Caused by Extended-Spectrum-Beta-Lactamase-, AmpC-, and Carbapenemase-Producing Enterobacteriaceae. Clin Microbiol Rev. 2018 Feb 14;31(2):e00079-17. doi: 10.1128/CMR.00079-17. Print 2018 Apr.

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• Mensa J, Soriano A, Llinares P, Barberan J, Montejo M, Salavert M, Alvarez-Rocha L, Maseda E, Moreno A, Pasquau J, Gomez J, Parra J, Candel F, Azanza JR, Garcia JE, Marco F, Soy D, Grau S, Arias J, Fortun J, de Alarcon CA, Picazo J; Sociedad Espanola de Quimioterapia (SEQ); Sociedad Espanola de Medicina Interna (SEMI); GTIPO-Sociedad Espanola de Anestesiologia y Reanimacion. [Guidelines for antimicrobial treatment of the infection by Staphylococcus aureus]. Rev Esp Quimioter. 2013 Jan;26 Suppl 1:1-84. No abstract available. Spanish.

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  PMID: 27624957 BACKGROUND

• Ficha técnica de ceftarolina. https://ec.europa.eu/health/documents/communityregister/2012/20120823123835/anx_123835_es.pdf

  BACKGROUND

• Ficha técnica de tedizolid. http://www.ema.europa.eu/docs/es_ES/document_library /EPAR_-_Product_Information/human/002846/WC500184802.pdf

  BACKGROUND

• Informa de posicionamiento terapéutico de dalbavancina. https://www.aemps.gob.es/medicamentosUsoHumano/informesPublicos/docs/IPTdalbavancina-Xydalba.pdf

  BACKGROUND

• Ficha técnica de ceftazidima-avibactam. http://www.ema.europa.eu/docs/es_ES /document_library /EPAR_-_Product_Information/human/004027/WC500210234.pdf

  BACKGROUND

• Ficha técnica de ceftolozano-tazobactam. https://ec.europa.eu/health/documents /communityregister/2015/20150918132786/anx_132786_es.pdf

  BACKGROUND

• Ficha técnica de isavuconazol. https://ec.europa.eu/health/documents/community-register/2015/20151015132781/anx_132781_es.pdf.

  BACKGROUND

• Cosimi RA, Beik N, Kubiak DW, Johnson JA. Ceftaroline for Severe Methicillin-Resistant Staphylococcus aureus Infections: A Systematic Review. Open Forum Infect Dis. 2017 May 2;4(2):ofx084. doi: 10.1093/ofid/ofx084. eCollection 2017 Spring.

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• Iacovelli A, Spaziante M, Al Moghazi S, Giordano A, Ceccarelli G, Venditti M. A challenging case of carbapenemase-producing Klebsiella pneumoniae septic thrombophlebitis and right mural endocarditis successfully treated with ceftazidime/avibactam. Infection. 2018 Oct;46(5):721-724. doi: 10.1007/s15010-018-1166-9. Epub 2018 Jun 20.

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MeSH Terms

Conditions

Bacterial Infections; Mycoses

Condition Hierarchy (Ancestors)

Bacterial Infections and Mycoses; Infections

Study Officials

• Zaira Palacios Baena

  University Hospital Virgen Macarena

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zaira Palacios Baena

CONTACT

34 653276353; zaira.palacios.baena@hotmail.com

Pilar Retamar Gentil

CONTACT

600162313; pilaretamar@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 4, 2019
• First Posted: May 8, 2019
• Study Start: July 9, 2019
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2022
• Last Updated: June 1, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

ES (14)