- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03543605
Clinical/Microbiological Impact of a Specific Antimicrobial Stewardship Program for Nursing Homes (PROA-SENIOR)
Impacto clínico y microbiológico de un Programa de optimización de Antimicrobianos específico Para Centros Socio-sanitarios. Ensayo clínico Aleatorizado Por Grupos. Ensayo PROA-SENIOR
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.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Seville, Spain, 41013
- Virgen del Rocio University Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: PROA Experimental
It consists of the intervention measures described in the general antimicrobial stewardship program (PROA Control) plus clinical advice.
|
PROA Control plus clinical advice
|
Other: PROA Control
The intervention of the general antimicrobial stewardship program (PROA) contains the following set of measures:
|
PROA Control
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
From date of randomization, assessed monthly up to 12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
From date of randomization, assessed monthly up to 12 months
|
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.
|
From date of randomization, assessed monthly up to 12 months
|
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.
|
From date of randomization, assessed monthly up to 12 months
|
Collaborators and Investigators
Investigators
- Principal Investigator: José Miguel Cisneros Herreros, PhD, MD, Virgen del Rocio University Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- PROA-SENIOR (PRO-FIS-2017-01)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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