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出境医 / 临床实验 / Study to Optimize the Use of New Antibiotics (NEW_SAFE)

Study to Optimize the Use of New Antibiotics (NEW_SAFE)

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:

  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.

Condition or disease Intervention/treatment Phase
Bacterial Infections Fungal Infection Behavioral: Non-impositive Program for Optimizing the Use of Antimicrobials Not Applicable

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated 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.
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 : July 9, 2019
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 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.
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 :
  1. Total antibiotic consumption [ Time Frame: 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 :
  1. Total cost per antimicrobial [ Time Frame: Yearly from date of intervention up to 24 months of follow-up ]
    Total expense in euros of each antimicrobial per 1000 stays

  2. Mortality rate [ Time Frame: 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.

  3. Total length of hospital stay [ Time Frame: 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.

  4. Incidence of colitis due to Clostridium difficile. [ Time Frame: Monthly from date of intervention up to 24 months of follow-up ]
    Clostridium difficile infection documented during treatment with any of the antibiotics described

  5. Percentage of patients with infections by multiresistant microorganisms. Colonization during treatment by resistant microorganisms [ Time Frame: Monthly from date of intervention up to 24 months of follow-up ]
    Percentage of patients with infections by multiresistant microorganisms in each cohort.

  6. Percentage of patients colonized by multiresistant microorganisms [ Time Frame: 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.

  7. Re-admission rate [ Time Frame: 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
Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Contacts and Locations

Contacts
Layout table for location contacts
Contact: Zaira Palacios Baena 34 653276353 zaira.palacios.baena@hotmail.com
Contact: Pilar Retamar Gentil 600162313 pilaretamar@hotmail.com

Locations
Layout table for location information
Spain
Hospital de Poniente-El Ejido Suspended
Almería, Spain
University Hospital Puerta del Mar Recruiting
Cadiz, Spain
Contact: Andrés Martín Aspas       andres.martin.sspa@juntadeandalucia.es   
University Hospital Reina Sofía Recruiting
Córdoba, Spain
Contact: Juan José Castón Osorio       juanjoco2005@yahoo.es   
Hospital Clínico Universitario San Cecilio Recruiting
Granada, Spain
Contact: Francisco Anguita Santos       miparedro@gmail.com   
University Hospital Virgen de las Nieves Recruiting
Granada, Spain
Contact: Pilar Aznarte Padial       aznarte.sspa@juntadeandalucia.es   
Área Hospitalaria Juan Ramón Jiménez Recruiting
Huelva, Spain
Contact: Francisco Javier Martinez Marcos       fcojmtz@telefonica.net   
Complejo Hospitalario de Jaén Recruiting
Jaén, Spain
Contact: Carmen Herrero Rodríguez       gonees.data@hotmail.es   
University Hospital de Jerez de la Frontera Recruiting
Jerez De La Frontera, Spain
Contact: Salvador López Cárdenas       salvador_lopez_cardenas@jerez.es   
Hospital Regional Universitario de Málaga Recruiting
Málaga, Spain
Contact: Lucía Valiente De Santis       luciabvds26@hotmail.com   
Sub-Investigator: Ignacio Márquez Gómez         
University Hospital Virgen de la Victoria Recruiting
Málaga, Spain
Contact: Guillermo Gonzalo Ojeda Burgos       guilleojeda@gmail.com   
Hospital de Puerto Real Recruiting
Puerto Real, Spain
Contact: Patricia Jimenez Aguilar       patriciajaguilar@gmail.com   
University Hospital Virgen de Valme Recruiting
Sevilla, Spain
Contact: Juan E Corzo Delgado       juanecorzo@telefonica.net   
University Hospital Virgen del Rocío Recruiting
Sevilla, Spain
Contact: Julia M Praena Segovia       juliapraena@gmail.com   
University Hospital Virgen Macarena (Sevilla). Recruiting
Sevilla, Spain
Contact: Zaira Palacios       zaira.palacios.baena@hotmail.com   
Principal Investigator: Zaira R Palacios Baena         
Principal Investigator: Pilar Retamar Gentil         
Sub-Investigator: Natalia A Maldonado Lizarazo         
Sub-Investigator: Lorena López Cerero         
Sub-Investigator: Adoración Valiente         
Sub-Investigator: Margarita Beltrán         
Sponsors and Collaborators
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Investigators
Layout table for investigator information
Principal Investigator: Zaira Palacios Baena University Hospital Virgen Macarena
Tracking Information
First Submitted Date  ICMJE April 4, 2019
First Posted Date  ICMJE May 8, 2019
Last Update Posted Date June 1, 2020
Actual Study Start Date  ICMJE July 9, 2019
Estimated Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 7, 2019) 		Total antibiotic consumption [ Time Frame: Yearly from date of intervention up to 24 months of follow-up ]
Defined daily doses (DDD) of each antibiotic per 1000 stays
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 7, 2019)
  • Total cost per antimicrobial [ Time Frame: Yearly from date of intervention up to 24 months of follow-up ]
    Total expense in euros of each antimicrobial per 1000 stays
  • Mortality rate [ Time Frame: 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 [ Time Frame: 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. [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study to Optimize the Use of New Antibiotics
Official Title  ICMJE Quasi-experimental Intervention Study to Optimize the Use of New Antibiotics (Project NEW_SAFE)
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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.
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Bacterial Infections
  • Fungal Infection
Intervention  ICMJE 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.
Study Arms  ICMJE
  • 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.
  • 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.
    Intervention: Behavioral: Non-impositive Program for Optimizing the Use of Antimicrobials
  • 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.
Publications *
  • Versporten A, Zarb P, Caniaux I, Gros MF, Drapier N, Miller M, Jarlier V, Nathwani D, Goossens H; Global-PPS network. Antimicrobial consumption and resistance in adult hospital inpatients in 53 countries: results of an internet-based global point prevalence survey. Lancet Glob Health. 2018 Jun;6(6):e619-e629. doi: 10.1016/S2214-109X(18)30186-4. Epub 2018 Apr 23. Erratum in: Lancet Glob Health. 2018 Sep;6(9):e968.
  • Rodríguez-Baño J, Cisneros JM, Cobos-Trigueros N, Fresco G, Navarro-San Francisco C, Gudiol C, Horcajada JP, López-Cerero L, Martínez JA, Molina J, Montero M, Paño-Pardo JR, Pascual A, Peña C, Pintado V, Retamar P, Tomás M, Borges-Sa M, Garnacho-Montero J, Bou G; Study Group of Nosocomial Infections (GEIH) of the Spanish Society of Infectious Diseases, Infectious Diseases (SEIMC). Diagnosis and antimicrobial treatment of invasive infections due to multidrug-resistant Enterobacteriaceae. Guidelines of the Spanish Society of Infectious Diseases and Clinical Microbiology. Enferm Infecc Microbiol Clin. 2015 May;33(5):337.e1-337.e21. doi: 10.1016/j.eimc.2014.11.009. Epub 2015 Jan 15.
  • López Cortés LE, Mujal Martínez A, Fernández Martínez de Mandojana M, Martín N, Gil Bermejo M, Solà Aznar J, Villegas Bruguera E, Peláez Cantero MJ, Retamar Gentil P, Delgado Vicente M, González-Ramallo VJ, Ponce González MÁ, Mirón Rubio M, Gómez Rodríguez de Mendarozqueta MM, Goenaga Sánchez MÁ, Sanroma Mendizábal P, Delgado Mejía E, Pajarón Guerrero M; Sociedad Española de Enfermedades Infecciosas y Microbiología Clínica (SEIMC), the Sociedad Española de Hospitalización a Domicilio (SEHAD) Group. Executive summary of outpatient parenteral antimicrobial therapy: Guidelines of the Spanish Society of Clinical Microbiology and Infectious Diseases and the Spanish Domiciliary Hospitalisation Society. Enferm Infecc Microbiol Clin (Engl Ed). 2019 Jun - Jul;37(6):405-409. doi: 10.1016/j.eimc.2018.03.012. Epub 2018 May 18. English, Spanish.
  • Tacconelli E, Carrara E, Savoldi A, Harbarth S, Mendelson M, Monnet DL, Pulcini C, Kahlmeter G, Kluytmans J, Carmeli Y, Ouellette M, Outterson K, Patel J, Cavaleri M, Cox EM, Houchens CR, Grayson ML, Hansen P, Singh N, Theuretzbacher U, Magrini N; WHO Pathogens Priority List Working Group. Discovery, research, and development of new antibiotics: the WHO priority list of antibiotic-resistant bacteria and tuberculosis. Lancet Infect Dis. 2018 Mar;18(3):318-327. doi: 10.1016/S1473-3099(17)30753-3. Epub 2017 Dec 21.
  • Plan estratégico y de acción para reducir el riesgo de selección y diseminación de la resistencia a los antibióticos http://www.resistenciaantibioticos.es/es/system/files/ content_images/plan_nacional_resistencia_antibioticos.pdf
  • Rodríguez-Baño J, Paño-Pardo JR, Alvarez-Rocha L, Asensio Á, 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.
  • Hernández-García I, Sáenz-González MC, Meléndez D. [Assessment of an educational program for the prevention of healthcare-associated infections]. Rev Calid Asist. 2013 Mar-Apr;28(2):96-108. doi: 10.1016/j.cali.2012.09.001. Epub 2012 Nov 2. Spanish.
  • 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
  • López-Cerero L, Egea P, Gracia-Ahufinger I, González-Padilla M, Rodríguez-López F, Rodríguez-Baño 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.
  • PIRASOA: actividad laboratorio de referencia. Accesible en: pirasoa.iavante.es/mod/resource/view.php?id=797
  • Rodríguez-Baño J, Gutiérrez-Gutiérrez 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). pii: e00079-17. doi: 10.1128/CMR.00079-17. Print 2018 Apr. Review.
  • Mensa J, Soriano A, Llinares P, Barberán J, Montejo M, Salavert M, Alvarez-Rocha L, Maseda E, Moreno A, Pasquau J, Gómez J, Parra J, Candel J, Azanza JR, García JE, Marco F, Soy D, Grau S, Arias J, Fortún J, de Alarcón CA, Picazo J; Sociedad Española de Quimioterapia (SEQ); Sociedad Española de Medicina Interna (SEMI); GTIPO-Sociedad Española de Anestesiología y Reanimación. [Guidelines for antimicrobial treatment of the infection by Staphylococcus aureus]. Rev Esp Quimioter. 2013 Jan;26 Suppl 1:1-84. Review. Spanish.
  • Spellberg B, Bonomo RA. Editorial Commentary: Ceftazidime-Avibactam and Carbapenem-Resistant Enterobacteriaceae: "We're Gonna Need a Bigger Boat". Clin Infect Dis. 2016 Dec 15;63(12):1619-1621. Epub 2016 Sep 13.
  • Ficha técnica de ceftarolina. https://ec.europa.eu/health/documents/communityregister/2012/20120823123835/anx_123835_es.pdf
  • Ficha técnica de tedizolid. http://www.ema.europa.eu/docs/es_ES/document_library /EPAR_-_Product_Information/human/002846/WC500184802.pdf
  • Informa de posicionamiento terapéutico de dalbavancina. https://www.aemps.gob.es/medicamentosUsoHumano/informesPublicos/docs/IPTdalbavancina-Xydalba.pdf
  • Ficha técnica de ceftazidima-avibactam. http://www.ema.europa.eu/docs/es_ES /document_library /EPAR_-_Product_Information/human/004027/WC500210234.pdf
  • Ficha técnica de ceftolozano-tazobactam. https://ec.europa.eu/health/documents /communityregister/2015/20150918132786/anx_132786_es.pdf
  • Ficha técnica de isavuconazol. https://ec.europa.eu/health/documents/community-register/2015/20151015132781/anx_132781_es.pdf.
  • 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. Review.
  • Zasowski EJ, Trinh TD, Claeys KC, Casapao AM, Sabagha N, Lagnf AM, Klinker KP, Davis SL, Rybak MJ. Multicenter Observational Study of Ceftaroline Fosamil for Methicillin-Resistant Staphylococcus aureus Bloodstream Infections. Antimicrob Agents Chemother. 2017 Jan 24;61(2). pii: e02015-16. doi: 10.1128/AAC.02015-16. Print 2017 Feb.
  • Si S, Durkin MJ, Mercier MM, Yarbrough ML, Liang SY. Successful Treatment of Prosthetic Joint Infection due to Vancomycin-resistant Enterococci with Tedizolid. Infect Dis Clin Pract (Baltim Md). 2017 Mar;25(2):105-107. doi: 10.1097/IPC.0000000000000469.
  • Nigo M, Luce AM, Arias CA. Long-term Use of Tedizolid as Suppressive Therapy for Recurrent Methicillin-Resistant Staphylococcus aureus Graft Infection. Clin Infect Dis. 2018 Jun 1;66(12):1975-1976. doi: 10.1093/cid/ciy041.
  • Tobudic S, Forstner C, Burgmann H, Lagler H, Ramharter M, Steininger C, Vossen MG, Winkler S, Thalhammer F. Dalbavancin as Primary and Sequential Treatment for Gram-Positive Infective Endocarditis: 2-Year Experience at the General Hospital of Vienna. Clin Infect Dis. 2018 Aug 16;67(5):795-798. doi: 10.1093/cid/ciy279.
  • Bouza E, Valerio M, Soriano A, Morata L, Carus EG, Rodríguez-González C, Hidalgo-Tenorio MC, Plata A, Muñoz P, Vena A; DALBUSE Study Group (Dalbavancina: Estudio de su uso clinico en España). Dalbavancin in the treatment of different gram-positive infections: a real-life experience. Int J Antimicrob Agents. 2018 Apr;51(4):571-577. doi: 10.1016/j.ijantimicag.2017.11.008. Epub 2017 Nov 24.
  • 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. Erratum in: Infection. 2018 Jul 10;:.
  • Gofman N, To K, Whitman M, Garcia-Morales E. Successful treatment of ventriculitis caused by Pseudomonas aeruginosa and carbapenem-resistant Klebsiella pneumoniae with i.v. ceftazidime-avibactam and intrathecal amikacin. Am J Health Syst Pharm. 2018 Jul 1;75(13):953-957. doi: 10.2146/ajhp170632.
  • De León-Borrás R, Álvarez-Cardona J, Vidal JA, Guiot HM. Ceftazidime/Avibactam for Refractory Bacteremia, Vertebral Diskitis/Osteomyelitis with Pre-Vertebral Abscess and Bilateral Psoas Pyomyositis Secondary to Klebsiella Pneumoniae Carbapenemase-Producing Bacteria (KPC). P R Health Sci J. 2018 Jun;37(2):128-131.
  • Dietl B, Sánchez I, Arcenillas P, Cuchi E, Gómez L, González de Molina FJ, Boix-Palop L, Nicolás J, Calbo E. Ceftolozane/tazobactam in the treatment of osteomyelitis and skin and soft-tissue infections due to extensively drug-resistant Pseudomonas aeruginosa: clinical and microbiological outcomes. Int J Antimicrob Agents. 2018 Mar;51(3):498-502. doi: 10.1016/j.ijantimicag.2017.11.003. Epub 2017 Nov 20.
  • Vickery SB, McClain D, Wargo KA. Successful Use of Ceftolozane-Tazobactam to Treat a Pulmonary Exacerbation of Cystic Fibrosis Caused by Multidrug-Resistant Pseudomonas aeruginosa. Pharmacotherapy. 2016 Oct;36(10):e154-e159. doi: 10.1002/phar.1825. Epub 2016 Sep 1.
  • Plant AJ, Dunn A, Porter RJ. Ceftolozane-tazobactam resistance induced in vivo during the treatment of MDR Pseudomonas aeruginosa pneumonia. Expert Rev Anti Infect Ther. 2018 May;16(5):367-368. doi: 10.1080/14787210.2018.1473079.
  • Gaibani P, Campoli C, Lewis RE, Volpe SL, Scaltriti E, Giannella M, Pongolini S, Berlingeri A, Cristini F, Bartoletti M, Tedeschi S, Ambretti S. In vivo evolution of resistant subpopulations of KPC-producing Klebsiella pneumoniae during ceftazidime/avibactam treatment. J Antimicrob Chemother. 2018 Jun 1;73(6):1525-1529. doi: 10.1093/jac/dky082.
  • Davey P, Marwick CA, Scott CL, Charani E, McNeil K, Brown E, Gould IM, Ramsay CR, Michie S. Interventions to improve antibiotic prescribing practices for hospital inpatients. Cochrane Database Syst Rev. 2017 Feb 9;2:CD003543. doi: 10.1002/14651858.CD003543.pub4. Review.
  • Diamond IR, Grant RC, Feldman BM, Pencharz PB, Ling SC, Moore AM, Wales PW. Defining consensus: a systematic review recommends methodologic criteria for reporting of Delphi studies. J Clin Epidemiol. 2014 Apr;67(4):401-9. doi: 10.1016/j.jclinepi.2013.12.002. Review.
  • Palacios-Baena ZR, Valiente de Santis L, Maldonado N, Rosso-Fernández CM, Borreguero I, Herrero-Rodríguez C, López-Cárdenas S, Martínez-Marcos FJ, Martín-Aspas A, Jiménez-Aguilar P, Castón JJ, Anguita-Santos F, Ojeda-Burgos G, Aznarte-Padial MP, Praena-Segovia J, Corzo-Delgado JE, Esteban-Moreno MÁ, Rodríguez-Baño J, Retamar P. Quasiexperimental intervention study protocol to optimise the use of new antibiotics in Spain: the NEW_SAFE project. BMJ Open. 2020 Jul 31;10(7):e035460. doi: 10.1136/bmjopen-2019-035460.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 7, 2019) 		900
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2022
Estimated Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Zaira Palacios Baena 34 653276353 zaira.palacios.baena@hotmail.com
Contact: Pilar Retamar Gentil 600162313 pilaretamar@hotmail.com
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03941951
Other Study ID Numbers  ICMJE FIS-TED-2019-01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Study Sponsor  ICMJE Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Zaira Palacios Baena University Hospital Virgen Macarena
PRS Account Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Verification Date May 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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