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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Total cost per antimicrobial | Total expense in euros of each antimicrobial per 1000 stays | Yearly from date of intervention up to 24 months of follow-up |
| Mortality rate | Mortality from any cause at 7, 14 and 30 days after the start of the treatment. |
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Pre-intervention cohort (historical):
Inclusion criteria:
Exclusion criteria:
• There are no exclusion criteria except for age.
Intervention cohort:
Inclusion criteria:
Exclusion criteria:
• There are no exclusion criteria except for age.
Safety cohort:
Inclusion criteria:
Exclusion criteria:
• There are no exclusion criteria except for age.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zaira Palacios Baena | Contact | 34 653276353 | zaira.palacios.baena@hotmail.com | |
| Pilar Retamar Gentil | Contact | 600162313 | pilaretamar@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Zaira Palacios Baena | University Hospital Virgen Macarena | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital de Poniente-El Ejido | Suspended | Almería | Spain | |||
| University Hospital Puerta del Mar |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29681513 | Background | 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. | |
| 25600218 |
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| ID | Term |
|---|---|
| D001424 | Bacterial Infections |
| D009181 | Mycoses |
| ID | Term |
|---|---|
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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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.
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|
| At 7, 14 and 30 days after the start of the treatment. |
| Total length of hospital stay | 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. | Monthly from date of intervention up to 24 months of follow-up |
| Incidence of colitis due to Clostridium difficile. | Clostridium difficile infection documented during treatment with any of the antibiotics described | 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 | Percentage of patients with infections by multiresistant microorganisms in each cohort. | Monthly from date of intervention up to 24 months of follow-up |
| Percentage of patients colonized by multiresistant microorganisms | Percentage of patients colonized by multiresistant microorganisms in each cohort after completion of treatment with antibiotic under study. | Monthly from date of intervention up to 24 months of follow-up |
| Re-admission rate | Re-admission of the patient in the hospital at 90 days after the start of the antibiotic treatment. | 90 days after the start of the antibiotic treatment. |
| Recruiting |
| Cadiz |
| Spain |
|
| University Hospital Reina Sofía | Recruiting | Córdoba | Spain |
|
| Hospital Clínico Universitario San Cecilio | Recruiting | Granada | Spain |
|
| University Hospital Virgen de las Nieves | Recruiting | Granada | Spain |
|
| Área Hospitalaria Juan Ramón Jiménez | Recruiting | Huelva | Spain |
|
| Complejo Hospitalario de Jaén | Recruiting | Jaén | Spain |
|
| University Hospital de Jerez de la Frontera | Recruiting | Jerez de la Frontera | Spain |
|
| Hospital Regional Universitario de Málaga | Recruiting | Málaga | Spain |
|
| University Hospital Virgen de la Victoria | Recruiting | Málaga | Spain |
|
| Hospital de Puerto Real | Recruiting | Puerto Real | Spain |
|
| University Hospital Virgen de Valme | Recruiting | Seville | Spain |
|
| University Hospital Virgen del Rocío | Recruiting | Seville | Spain |
|
| University Hospital Virgen Macarena (Sevilla). | Recruiting | Seville | Spain |
|
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| 29276051 | Background | 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. |
| Background | 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 |
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| Background | 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 |
| 25446907 | 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. |
| Background | PIRASOA: actividad laboratorio de referencia. Accesible en: pirasoa.iavante.es/mod/resource/view.php?id=797 |
| 29444952 | 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. |
| 23824510 | Background | 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. |
| 27624957 | Background | 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. doi: 10.1093/cid/ciw639. Epub 2016 Sep 13. No abstract available. |
| 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. |
| 28702467 | 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. |
| 27895012 | Background | 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):e02015-16. doi: 10.1128/AAC.02015-16. Print 2017 Feb. |
| 28428726 | Background | 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. |
| 29370350 | Background | 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. No abstract available. |
| 29659732 | Background | 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. |
| 29180276 | Background | Bouza E, Valerio M, Soriano A, Morata L, Carus EG, Rodriguez-Gonzalez C, Hidalgo-Tenorio MC, Plata A, Munoz P, Vena A; DALBUSE Study Group (Dalbavancina: Estudio de su uso clinico en Espana). 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. |
| 29926399 | Background | 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. |
| 29941534 | Background | 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. |
| 29905925 | Background | De Leon-Borras R, Alvarez-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. |
| 29158144 | Background | Dietl B, Sanchez I, Arcenillas P, Cuchi E, Gomez L, Gonzalez de Molina FJ, Boix-Palop L, Nicolas 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. |
| 27522066 | Background | 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. |
| 29727213 | Background | 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. No abstract available. |
| 29566151 | Background | 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. |
| 28178770 | Background | 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(2):CD003543. doi: 10.1002/14651858.CD003543.pub4. |
| 24581294 | Background | 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. |
| 32737088 | Derived | Palacios-Baena ZR, Valiente de Santis L, Maldonado N, Rosso-Fernandez CM, Borreguero I, Herrero-Rodriguez C, Lopez-Cardenas S, Martinez-Marcos FJ, Martin-Aspas A, Jimenez-Aguilar P, Caston JJ, Anguita-Santos F, Ojeda-Burgos G, Aznarte-Padial MP, Praena-Segovia J, Corzo-Delgado JE, Esteban-Moreno MA, Rodriguez-Bano 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. |