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:
Condition or disease | Intervention/treatment | Phase |
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Bacterial Infections Fungal Infection | Behavioral: Non-impositive Program for Optimizing the Use of Antimicrobials | Not Applicable |
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 |
Arm | Intervention/treatment |
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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.
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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.
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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.
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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.
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.
Contact: Zaira Palacios Baena | 34 653276353 | zaira.palacios.baena@hotmail.com | |
Contact: Pilar Retamar Gentil | 600162313 | pilaretamar@hotmail.com |
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 |
Principal Investigator: | Zaira Palacios Baena | University Hospital Virgen Macarena |
Tracking Information | |||||||||
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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 |
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
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Original Primary Outcome Measures ICMJE | Same as current | ||||||||
Change History | |||||||||
Current Secondary Outcome Measures ICMJE |
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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:
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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 |
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Condition ICMJE |
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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.
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Study Arms ICMJE |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status ICMJE | Recruiting | ||||||||
Estimated Enrollment ICMJE |
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:
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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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||
Contacts ICMJE |
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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 |
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IPD Sharing Statement ICMJE |
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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 |
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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 |