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Bacterial InfectionsNEW_SAFENCT03941951

Study to Optimize the Use of New Antibiotics

A study testing Non-impositive Program for Optimizing the Use of Antimicrobials in people with Bacterial Infections and Fungal Infection, run by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla at 14 sites in Spain.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Bacterial Infections, Fungal Infection
What is being tested?
Non-impositive Program for Optimizing the Use of Antimicrobials
Could I receive a placebo?
No, everyone receives an active treatment
How many people
900 participants
Where
14 sitesSpain
Study dates
9 Jul 2019to 31 Dec 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 19Show fewer
  • 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).

Who cannot join

  • There are no exclusion criteria except for age.
  • Intervention cohort:
  • There are no exclusion criteria except for age.
  • Safety cohort:
  • There are no exclusion criteria except for age.

Trial locations and contacts

14 sites in 1 country.

Zaira Palacios Baena contact

34 653276353

zaira.palacios.baena@hotmail.com

Pilar Retamar Gentil contact

600162313

pilaretamar@hotmail.com

14 sites in 1 country

Spain14 sites, 13 recruiting

  • Hospital de Poniente-El Ejido

    Almería

    Suspended

  • University Hospital Puerta del Mar

    Cadiz

    Andrés Martín Aspas, andres.martin.sspa@juntadeandalucia.es

    Recruiting

  • University Hospital Reina Sofía

    Córdoba

    Juan José Castón Osorio, juanjoco2005@yahoo.es

    Recruiting

  • Hospital Clínico Universitario San Cecilio

    Granada

    Francisco Anguita Santos, miparedro@gmail.com

    Recruiting

  • University Hospital Virgen de las Nieves

    Granada

    Pilar Aznarte Padial, aznarte.sspa@juntadeandalucia.es

    Recruiting

  • Área Hospitalaria Juan Ramón Jiménez

    Huelva

    Francisco Javier Martinez Marcos, fcojmtz@telefonica.net

    Recruiting

  • Complejo Hospitalario de Jaén

    Jaén

    Carmen Herrero Rodríguez, gonees.data@hotmail.es

    Recruiting

  • University Hospital de Jerez de la Frontera

    Jerez de la Frontera

    Salvador López Cárdenas, salvador_lopez_cardenas@jerez.es

    Recruiting

  • Hospital Regional Universitario de Málaga

    Málaga

    Lucía Valiente De Santis, luciabvds26@hotmail.com

    Ignacio Márquez Gómez

    Recruiting

  • University Hospital Virgen de la Victoria

    Málaga

    Guillermo Gonzalo Ojeda Burgos, guilleojeda@gmail.com

    Recruiting

  • Hospital de Puerto Real

    Puerto Real

    Patricia Jimenez Aguilar, patriciajaguilar@gmail.com

    Recruiting

  • University Hospital Virgen de Valme

    Seville

    Juan E Corzo Delgado, juanecorzo@telefonica.net

    Recruiting

  • University Hospital Virgen del Rocío

    Seville

    Julia M Praena Segovia, juliapraena@gmail.com

    Recruiting

  • University Hospital Virgen Macarena (Sevilla).

    Seville

    Zaira Palacios, zaira.palacios.baena@hotmail.com

    Zaira R Palacios Baena

    Recruiting

Other trials in Spain

About this study

Official title: Quasi-experimental Intervention Study to Optimize the Use of New Antibiotics (Project NEW_SAFE)

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.
Being tested
Non-impositive Program for Optimizing the Use of Antimicrobials
Keywords
Quasi-experimental study, Multidrug resistant bacteria, Antimicrobial stewardship, Ceftaroline, Tedizolid, Dalbavancin, Ceftazidime-avibactam, Ceftolozane-tazobactam, Isavuconazole
Medical subject headings
Bacterial Infections, Mycoses

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Non-impositive Program for Optimizing the Use of AntimicrobialsBehavioural

    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 groups in NCT03941951
Study groupRoleWhat they receive
Pre-intervention CohortNo interventionCohort 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 cohortOtherCohort of patients with complex infections treated with ceftaroline, tedizolid, dalbavancin, ceftazidime-avibactam, ceftolozane-tazobactam or isavuconazole from January 2010 to June 2021.
Receives: Behavioral: Non-impositive Program for Optimizing the Use of Antimicrobials
Safety cohortNo interventionCohort 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Total antibiotic consumption

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

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

Secondary outcomes (7)

  1. Total cost per antimicrobial

    Total expense in euros of each antimicrobial per 1000 stays

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

  2. Mortality rate

    Mortality from any cause at 7, 14 and 30 days after the start of the treatment.

    Measured: At 7, 14 and 30 days after the start of the treatment.

  3. 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.

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

  4. Incidence of colitis due to Clostridium difficile.

    Clostridium difficile infection documented during treatment with any of the antibiotics described

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

  5. 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.

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

  6. 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.

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

  7. Re-admission rate

    Re-admission of the patient in the hospital at 90 days after the start of the antibiotic treatment.

    Measured: 90 days after the start of the antibiotic treatment.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 May 2019
  2. Study start9 Jul 2019
  3. Primary completion31 Dec 2020 (estimated)
  4. Study completion31 Dec 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
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)
Enrolment
900 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03941951
Sponsor's protocol ID
FIS-TED-2019-01
Acronym
NEW_SAFE
Status last verified
May 2020
First submitted
4 Apr 2019
Last updated
1 Jun 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 29681513

  • Rodriguez-Bano J, Cisneros JM, Cobos-Trigueros N, Fresco G, Navarro-San Francisco C, Gudiol C, Horcajada JP, Lopez-Cerero L, Martinez JA, Molina J, Montero M, Pano-Pardo JR, Pascual A, Pena C, Pintado V, Retamar P, Tomas 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.

    PubMed 25600218

  • Lopez Cortes LE, Mujal Martinez A, Fernandez Martinez de Mandojana M, Martin N, Gil Bermejo M, Sola Aznar J, Villegas Bruguera E, Pelaez Cantero MJ, Retamar Gentil P, Delgado Vicente M, Gonzalez-Ramallo VJ, Ponce Gonzalez MA, Miron Rubio M, Gomez Rodriguez de Mendarozqueta MM, Goenaga Sanchez MA, Sanroma Mendizabal P, Delgado Mejia E, Pajaron Guerrero M; Sociedad Espanola de Enfermedades Infecciosas y Microbiologia Clinica (SEIMC), the Sociedad Espanola de Hospitalizacion 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.

    PubMed 29784453

  • 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.

    PubMed 29276051

  • 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

  • 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.

    PubMed 22137161

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

  • 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

  • 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.

    PubMed 25446907

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

  • 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.

    PubMed 29444952

  • 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.

    PubMed 23824510

  • 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.

    PubMed 27624957

  • 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

Questions about this trial

What is this clinical trial studying?

A study testing Non-impositive Program for Optimizing the Use of Antimicrobials in people with Bacterial Infections and Fungal Infection, run by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla at 14 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 19 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 1 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Zaira Palacios Baena (34 653276353, zaira.palacios.baena@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Total antibiotic consumption (time frame: Yearly from date of intervention up to 24 months of follow-up). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03941951, which also lists 35 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2020.

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