Clinical trial NCT03543605: Clinical/Microbiological Impact of a Specific Antimicrobial Stewardship Program for Nursing Homes
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Human Microbiome
Antibiotic Resistant Infection
Nursing Homes
Lead sponsor: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Sponsor class: OTHER
First posted: 2018-06-01
Enrollment: 1667
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Change of Total antimicrobial pressure
timeFrame: From date of randomization, assessed monthly up to 12 months
Secondary outcomes:
measure: Antimicrobials adverse events
timeFrame: From date of randomization, assessed monthly up to 12 months
measure: Incidence of infections by multiresistant bacteria
timeFrame: From date of randomization, assessed monthly up to 12 months
measure: Incidence of infections of C. difficile
timeFrame: From date of randomization, assessed monthly up to 12 months
Other outcomes:
Locations:
city: Seville
country: Spain
facility: Virgen del Rocío University Hospital
Study officials:
affiliation: Virgen del Rocío University Hospital
name: José Miguel Cisneros Herreros, PhD, MD
role: PRINCIPAL_INVESTIGATOR
References: