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OpenTrials
Completed

NCT Number: NCT03543605

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

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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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Virgen del Rocío University Hospital

Seville, 41013, Spain

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PROA Experimental

Behavioral

PROA Control plus clinical advice

PROA Control

Other

PROA Control

Primary outcomes

  1. 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

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

Other

Registry information

Official study 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

Acronym: PROA-SENIOR

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Jun 1, 2018
Registry last updated
Mar 16, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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