Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Clinical/Microbiological Impact of a Specific Antimicrobial Stewardship Program for Nursing Homes (PROA-SENIOR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03543605
Recruitment Status : Not yet recruiting
First Posted : June 1, 2018
Last Update Posted : February 15, 2019
Sponsor:
Information provided by (Responsible Party):
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

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.


Condition or disease Intervention/treatment Phase
Human Microbiome Antibiotic Resistant Infection Nursing Homes Behavioral: PROA Experimental Other: PROA Control Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2220 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Masking Description: The study will be masked in the first year (pre-intervention) and open in the year of intervention
Primary Purpose: Prevention
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
Estimated Study Start Date : March 1, 2019
Estimated Primary Completion Date : June 1, 2020
Estimated Study Completion Date : June 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: PROA Experimental

It consists of the intervention measures described in the general antimicrobial stewardship program (PROA Control) plus clinical advice.

  • The clinical assessments have been adapted for this project to the unique characteristics of infectious diseases in nursing homes.
  • These are individual training activities whose main objective is to modify prescribing behaviors when they are inadequate and reinforce them when they are correct.
  • They are carried out between the medical adviser, an expert in infectious diseases, and the doctor of the nursing home, through the structured review of a case attended by the doctor in the last 24 hours. The recommendations are not compulsory, and do not seek to change the decisions made in that patient, but the future ones in the case that is necessary.
  • The counseling will be done by video-conference, with an approximate duration of 10 minutes. Each of the doctors will receive two monthly assessments during the intervention period.
Behavioral: PROA Experimental
PROA Control plus clinical advice

PROA Control

The intervention of the general antimicrobial stewardship program (PROA) contains the following set of measures:

  • Creation of the local team of the PROA: one of the Family Physicians responsible for the patients and the pharmacist of the reference hospital of the center.
  • Presentation of the project by the local team in its own center.
  • Choice of the Aljarafe guide as a reference document for the diagnosis and treatment of infectious diseases. It is an accredited guide and widely disseminated among primary care and hospital doctors.
  • Permanent information of the project (poster with its synthesis, a pocket triptych with the guide for the clinical management of the main clinical syndromes of infections in the residents of the nursing homes).
  • Feedback of the results that will serve each center to know the evolution of its results, and to stimulate the comparison with the other centers.
Other: PROA Control
PROA Control




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03543605


Contacts
Layout table for location contacts
Contact: Clara Rosso Fernández, PhD, MD 0034 955012144 claram.rosso.sspa@juntadeandalucia.es

Locations
Layout table for location information
Spain
Virgen del Rocío University Hospital Not yet recruiting
Seville, Spain, 41013
Contact: Clara Rosso Fernández, MD, PhD    0034 955 01 21 44    claram.rosso.sspa@juntadeandalucia.es   
Principal Investigator: José Miguel Cisneros Herreros, PhD, MD         
Sub-Investigator: María Aranzazu Irastorza Aldasoro         
Sub-Investigator: Carmen Serrano Martino         
Sub-Investigator: José Antonio Lepe Jiménez         
Sub-Investigator: José Antonio Expósito Tirado         
Sub-Investigator: Silvia Jiménez-Jorge, PhD         
Sub-Investigator: Eloy González Barbero         
Sub-Investigator: Rocío Fernández Urrusuno         
Sub-Investigator: Patricia Fernández Del Valle         
Sub-Investigator: José Molina Gil-Bermejo         
Sub-Investigator: Francisco José Guerrero García         
Sub-Investigator: María Victoria Gil Navarro         
Sub-Investigator: Gema Labrador Herrera         
Sub-Investigator: Joaquín Torres Moreno         
Sub-Investigator: Lucía Carmen Carrión Domínguez         
Sub-Investigator: Germán Peñalva Moreno         
Sub-Investigator: María Inmaculada Vázquez Cruz         
Sub-Investigator: Yolanda Santaella Guardiola         
Sponsors and Collaborators
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Investigators
Layout table for investigator information
Principal Investigator: José Miguel Cisneros Herreros, PhD, MD Virgen del Rocío University Hospital

Layout table for additonal information
Responsible Party: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
ClinicalTrials.gov Identifier: NCT03543605     History of Changes
Other Study ID Numbers: PROA-SENIOR (PRO-FIS-2017-01)
First Posted: June 1, 2018    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: February 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Anti-Infective Agents
Anti-Bacterial Agents