Clinical/Microbiological Impact of a Specific Antimicrobial Stewardship Program for Nursing Homes (PROA-SENIOR)
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|ClinicalTrials.gov Identifier: NCT03543605|
Recruitment Status : Not yet recruiting
First Posted : June 1, 2018
Last Update Posted : February 15, 2019
Background: In nursing homes, excessive and inappropriate use of antimicrobials, adverse events caused by these drugs, and infections by multidrug-resistant bacteria (MDRB) are more frequent than in the general population, posing a serious Public Health risk. Antimicrobial stewardship programs (ASP) are a key strategy to improve the use of antibiotics and to fight against bacterial resistance. Its usefulness in hospitals has been demonstrated. The Centers for Disease Control and Prevention urge the implementation ASP in nursing homes, with measures taken from the ASP in hospitals, but the available information is so limited that it does not allow specific recommendations to be made for these centers.
Objectives: To know if an ASP with an individual intervention measure, the clinical assessments, is better to an ASP with general intervention measures, both designed specifically for nursing homes, and what is the clinical and ecological impact of both, on the baseline situation.
Methods: a) Randomized clinical trial, in parallel groups, for comparison of both ASP. b) Quasi-Experimental study of timeseries for the evaluation of the clinical and ecological impact on the baseline situation. The following indicators will be analyzed: the use of antimicrobials in the centers; the intestinal microbiota diversity of nursing home residents, and the incidence of MDRB and Clostridium difficile infections; and the frequency of adverse events caused by antimicrobials and hospital admissions for infections. The study population will be 2.220 residents from 20 public nursing homes.
|Condition or disease||Intervention/treatment||Phase|
|Human Microbiome Antibiotic Resistant Infection Nursing Homes||Behavioral: PROA Experimental Other: PROA Control||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||2220 participants|
|Intervention Model:||Parallel Assignment|
|Masking Description:||The study will be masked in the first year (pre-intervention) and open in the year of intervention|
|Official Title:||Impacto clínico y microbiológico de un Programa de optimización de Antimicrobianos específico Para Centros Socio-sanitarios. Ensayo clínico Aleatorizado Por Grupos. Ensayo PROA-SENIOR|
|Estimated Study Start Date :||March 1, 2019|
|Estimated Primary Completion Date :||June 1, 2020|
|Estimated Study Completion Date :||June 1, 2020|
Experimental: PROA Experimental
It consists of the intervention measures described in the general antimicrobial stewardship program (PROA Control) plus clinical advice.
Behavioral: PROA Experimental
PROA Control plus clinical advice
The intervention of the general antimicrobial stewardship program (PROA) contains the following set of measures:
Other: PROA Control
- Change of Total antimicrobial pressure [ Time Frame: From date of randomization, assessed monthly up to 12 months ]Change from baseline of antimicrobial pressure, which will be measured using the recommended international standard, the defined daily dose (DDD) / 1000 residents / day
- Antimicrobials adverse events [ Time Frame: From date of randomization, assessed monthly up to 12 months ]The frequency of side effects of the antimicrobials that require admission will be evaluated by measuring the number of hospital admissions due to adverse effects of antimicrobials / 1000 residents / day.
- Incidence of infections by multiresistant bacteria [ Time Frame: From date of randomization, assessed monthly up to 12 months ]Incidence density (number of isolates in clinical samples / 1000 residents / day) of the following pathogens: quinolone resistant E.coli; E. coli BLEE, Klebsiella pneumoniae BLEE, carbapenemase-producing enterobacteria, methicillin-resistant Staphylococcus aureus (MRSA), in samples sent for culture.
- Incidence of infections of C. difficile [ Time Frame: From date of randomization, assessed monthly up to 12 months ]Incidence density (number of C. difficile isolates in clinical samples / 1000 residents / day) sent for toxin detection.
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): NCT03543605
|Contact: Clara Rosso Fernández, PhD, MD||0034 firstname.lastname@example.org|
|Virgen del Rocío University Hospital||Not yet recruiting|
|Seville, Spain, 41013|
|Contact: Clara Rosso Fernández, MD, PhD 0034 955 01 21 44 email@example.com|
|Principal Investigator: José Miguel Cisneros Herreros, PhD, MD|
|Sub-Investigator: María Aranzazu Irastorza Aldasoro|
|Sub-Investigator: Carmen Serrano Martino|
|Sub-Investigator: José Antonio Lepe Jiménez|
|Sub-Investigator: José Antonio Expósito Tirado|
|Sub-Investigator: Silvia Jiménez-Jorge, PhD|
|Sub-Investigator: Eloy González Barbero|
|Sub-Investigator: Rocío Fernández Urrusuno|
|Sub-Investigator: Patricia Fernández Del Valle|
|Sub-Investigator: José Molina Gil-Bermejo|
|Sub-Investigator: Francisco José Guerrero García|
|Sub-Investigator: María Victoria Gil Navarro|
|Sub-Investigator: Gema Labrador Herrera|
|Sub-Investigator: Joaquín Torres Moreno|
|Sub-Investigator: Lucía Carmen Carrión Domínguez|
|Sub-Investigator: Germán Peñalva Moreno|
|Sub-Investigator: María Inmaculada Vázquez Cruz|
|Sub-Investigator: Yolanda Santaella Guardiola|
|Principal Investigator:||José Miguel Cisneros Herreros, PhD, MD||Virgen del Rocío University Hospital|