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

Antibiotic Resistant Infection Clinical Trial

— PROA-SENIOR  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03543605
• Other study ID #: PROA-SENIOR (PRO-FIS-2017-01)
• Status: Completed
• Phase: N/A
• Start date: July 1, 2018
• Est. completion date: December 31, 2020

Study information

• Verified date: March 2022
• Source: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1667
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Public nursing homes under the ownership of the Department of Equality and Social Policies of the Junta de Andalucía

Exclusion Criteria:

• Nursing homes that are not under the ownership of the Department of Equality and Social Policies of the Junta de Andalucía

Related Conditions & MeSH terms

• Antibiotic Resistant Infection
• Human Microbiome
• Nursing Homes

Intervention

Behavioral:
• PROA Experimental
PROA Control plus clinical advice

Other:
• PROA Control
PROA Control

Locations

Country	Name	City	State
Spain	Virgen del Rocío University Hospital	Seville

Sponsors (1)

Lead Sponsor	Collaborator
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	Incidence of infections by multiresistant bacteria	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
Secondary	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