NCT03543605: PROA-SENIOR

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

Completed NA Last updated 16 March 2022

What this trial tests

NA trial testing PROA Experimental in Human Microbiome in 1,667 participants. Completed in 31 December 2020.

Timeline

1 July 2018

Primary endpoint
31 December 2020

31 December 2020

Quick facts

Lead sponsor	Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	prevention
Enrollment	1,667
Start date	1 July 2018
Primary completion	31 December 2020
Estimated completion	31 December 2020
Sites	1 location across Spain

Drugs / interventions tested

• PROA Experimental
• PROA Control

Conditions studied

• Human Microbiome — all drugs for Human Microbiome →
• Antibiotic Resistant Infection — all drugs for Antibiotic Resistant Infection →
• Nursing Homes — all drugs for Nursing Homes →

Sponsor

Fundación Pública Andaluza para la gestión de la Investigación en Sevilla — full company profile →

Who can join

Eligibility, any sex, with Human Microbiome or Antibiotic Resistant Infection. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Clinical and Ecological Impact of an Educational Program to Optimize Antibiotic Treatments in Nursing Homes (PROA-SENIOR): A Cluster, Randomized, Controlled Trial and Interrupted Time-Series Analysis.
   Peñalva G, Crespo-Rivas JC, Guisado-Gil AB, Rodríguez-Villodres Á, et al · · 2023 · cited 7× · PMID 36268822 · DOI 10.1093/cid/ciac834