Antibiotic Resistant Infection, Human Microbiome, Nursing Homes
Conditions
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.
Interventions
BEHAVIORALPROA Experimental
PROA Control plus clinical advice
OTHERPROA Control
PROA Control
Sponsors
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Investigator)
Masking description
The study will be masked in the first year (pre-intervention) and open in the year of intervention
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of Total antimicrobial pressure | 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
| Measure | Time frame | Description |
|---|---|---|
| Antimicrobials adverse events | 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. |
| Incidence of infections by multiresistant bacteria | 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. |
| Incidence of infections of C. difficile | 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. |
Countries
Spain
Outcome results
None listed