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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PROA Experimental | Experimental | It consists of the intervention measures described in the general antimicrobial stewardship program (PROA Control) plus clinical advice.
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| PROA Control | Other | The intervention of the general antimicrobial stewardship program (PROA) contains the following set of measures:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PROA Experimental | Behavioral | PROA Control plus clinical advice |
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| Measure | Description | Time Frame |
|---|---|---|
| Change of Total antimicrobial pressure | Change from baseline of antimicrobial pressure, which will be measured using the recommended international standard, the defined daily dose (DDD) / 1000 residents / day | From date of randomization, assessed monthly up to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Antimicrobials adverse events | 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. | From date of randomization, assessed monthly up to 12 months |
| Incidence of infections by multiresistant bacteria |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| José Miguel Cisneros Herreros, PhD, MD | Virgen del RocÃo University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Virgen del RocÃo University Hospital | Seville | 41013 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36268822 | Derived | Penalva G, Crespo-Rivas JC, Guisado-Gil AB, Rodriguez-Villodres A, Pachon-Ibanez ME, Cachero-Alba B, Rivas-Romero B, Gil-Moreno J, Galva-Borras MI, Garcia-Moreno M, Salamanca-Bautista MD, Martinez-Rascon MB, Cantudo-Cuenca MR, Ninahuaman-Poma RC, Enrique-Miron MLA, Perez-Barroso A, Marin-Ariza I, Gonzalez-Florido M, Mora-Santiago MDR, Belda-Rustarazo S, Exposito-Tirado JA, Rosso-Fernandez CM, Gil-Navarro MV, Lepe-Jimenez JA, Cisneros JM; PROA-SENIOR Study Group. Clinical and Ecological Impact of an Educational Program to Optimize Antibiotic Treatments in Nursing Homes (PROA-SENIOR): A Cluster, Randomized, Controlled Trial and Interrupted Time-Series Analysis. Clin Infect Dis. 2023 Mar 4;76(5):824-832. doi: 10.1093/cid/ciac834. |
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The study will be masked in the first year (pre-intervention) and open in the year of intervention
| PROA Control |
| Other |
PROA Control |
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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. |
| From date of randomization, assessed monthly up to 12 months |
| Incidence of infections of C. difficile | Incidence density (number of C. difficile isolates in clinical samples / 1000 residents / day) sent for toxin detection. | From date of randomization, assessed monthly up to 12 months |