NCT03543605

Clinical/Microbiological Impact of a Specific Antimicrobial Stewardship Program for Nursing Homes

Impacto clínico y microbiológico de un Programa de optimización de Antimicrobianos específico Para Centros Socio-sanitarios. Ensayo clínico Aleatorizado Por Grupos. Ensayo PROA-SENIOR

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,667 (actual)
• Sponsor: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Human Microbiome
• Antibiotic Resistant Infection
• Nursing Homes

Interventions

Type	Name	Description
BEHAVIORAL	PROA Experimental	PROA Control plus clinical advice
OTHER	PROA Control	PROA Control

Timeline

• Start date: 2018-07-01
• Primary completion: 2020-12-31
• Completion: 2020-12-31
• First posted: 2018-06-01
• Last updated: 2022-03-16

Locations

1 site across 1 country: Spain