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Trial record 86 of 10359 for:    Anti-Infective Agents AND Bacterial

Study to Optimize the Use of New Antibiotics (NEW_SAFE)

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ClinicalTrials.gov Identifier: NCT03941951
Recruitment Status : Not yet recruiting
First Posted : May 8, 2019
Last Update Posted : May 8, 2019
Sponsor:
Information provided by (Responsible Party):
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

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-impositive 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

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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)
Estimated Study Start Date : June 1, 2019
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics

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.



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.



Information from the National Library of Medicine

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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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03941951


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

Locations
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Spain
Hospital de Poniente-El Ejido Not yet recruiting
Almería, Spain
Contact: Ana Belén Lozano Serrano       anbelose@gmail.com   
University Hospital Puerta del Mar Not yet recruiting
Cadiz, Spain
Contact: Andrés Martín Aspas       andres.martin.sspa@juntadeandalucia.es   
University Hospital Reina Sofía Not yet recruiting
Córdoba, Spain
Contact: Juan José Castón Osorio       juanjoco2005@yahoo.es   
Hospital Clínico Universitario San Cecilio Not yet recruiting
Granada, Spain
Contact: Francisco Anguita Santos       miparedro@gmail.com   
University Hospital Virgen de las Nieves Not yet recruiting
Granada, Spain
Contact: Pilar Aznarte Padial       aznarte.sspa@juntadeandalucia.es   
Área Hospitalaria Juan Ramón Jiménez Not yet recruiting
Huelva, Spain
Contact: Francisco Javier Martinez Marcos       fcojmtz@telefonica.net   
Complejo Hospitalario de Jaén Not yet recruiting
Jaén, Spain
Contact: Carmen Herrero Rodríguez       gonees.data@hotmail.es   
University Hospital de Jerez de la Frontera
Jerez De La Frontera, Spain
Hospital Regional Universitario de Málaga Not yet recruiting
Málaga, Spain
Contact: Lucía Valiente De Santis       luciabvds26@hotmail.com   
Sub-Investigator: Ignacio Márquez Gómez         
University Hospital Virgen de la Victoria Not yet recruiting
Málaga, Spain
Contact: Guillermo Gonzalo Ojeda Burgos       guilleojeda@gmail.com   
Hospital de Puerto Real Not yet recruiting
Puerto Real, Spain
Contact: Patricia Jimenez Aguilar       patriciajaguilar@gmail.com   
University Hospital Virgen de Valme Not yet recruiting
Sevilla, Spain
Contact: Juan E Corzo Delgado       juanecorzo@telefonica.net   
University Hospital Virgen del Rocío Not yet recruiting
Sevilla, Spain
Contact: Julia M Praena Segovia       juliapraena@gmail.com   
University Hospital Virgen Macarena (Sevilla). Not yet 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
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Principal Investigator: Zaira Palacios Baena University Hospital Virgen Macarena

Publications:
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. 2019 Jun - Jul;37(6):405-409. doi: 10.1016/j.eimc.2018.03.012. Epub 2018 May 18. English, Spanish.
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
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
PIRASOA: actividad laboratorio de referencia. Accesible en: pirasoa.iavante.es/mod/resource/view.php?id=797
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.

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Responsible Party: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
ClinicalTrials.gov Identifier: NCT03941951     History of Changes
Other Study ID Numbers: FIS-TED-2019-01
First Posted: May 8, 2019    Key Record Dates
Last Update Posted: May 8, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla:
Quasi-experimental study
Multidrug resistant bacteria
Antimicrobial stewardship
Ceftaroline
Tedizolid
Dalbavancin
Ceftazidime-avibactam
Ceftolozane-tazobactam
Isavuconazole

Additional relevant MeSH terms:
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Bacterial Infections
Anti-Bacterial Agents
Avibactam, ceftazidime drug combination
Ceftolozane, tazobactam drug combination
Anti-Infective Agents
Antitubercular Agents
Antifungal Agents
Anti-Infective Agents, Urinary
Renal Agents
Infection
Communicable Diseases
Mycoses
Tazobactam
Ceftazidime
Ceftaroline fosamil
Dalbavancin
Avibactam
Ceftolozane
Tedizolid
Cephalosporins
Penicillanic Acid
Antibiotics, Antitubercular
Isavuconazole
beta-Lactamase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action