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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03543605
Other study ID # PROA-SENIOR (PRO-FIS-2017-01)
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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 AndalucĂ­a Exclusion Criteria: - Nursing homes that are not under the ownership of the Department of Equality and Social Policies of the Junta de AndalucĂ­a

Study Design


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
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