Human MicrobiomePROA-SENIORNCT03543605
Clinical/Microbiological Impact of a Specific Antimicrobial Stewardship Program for Nursing Homes
A study testing PROA Experimental in people with Human Microbiome and Antibiotic Resistant Infection, run by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Human Microbiome, Antibiotic Resistant Infection, Nursing Homes
- What is being tested?
- PROA Experimental
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,667 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jul 2018to 31 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Public nursing homes under the ownership of the Department of Equality and Social Policies of the Junta de Andalucía
Who cannot join
- Nursing homes that are not under the ownership of the Department of Equality and Social Policies of the Junta de Andalucía
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Being tested
- PROA Experimental, PROA Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PROA ExperimentalBehavioural
PROA Control plus clinical advice
PROA ControlOther
PROA Control
| Study group | Role | What they receive |
|---|---|---|
| PROA Experimental | 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. Receives: Behavioral: PROA Experimental |
| PROA Control | Other | 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. Receives: Other: PROA Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: From date of randomization, assessed monthly up to 12 months
Secondary outcomes (3)
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.
Measured: From date of randomization, assessed monthly up to 12 months
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.
Measured: From date of randomization, assessed monthly up to 12 months
Incidence of infections of C. difficile
Incidence density (number of C. difficile isolates in clinical samples / 1000 residents / day) sent for toxin detection.
Measured: From date of randomization, assessed monthly up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2018
- Study start1 Jul 2018
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Human MicrobiomeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 1,667 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- José Miguel Cisneros Herreros, PhD, MD, Principal investigator, Virgen del Rocío University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03543605
- Sponsor's protocol ID
- PROA-SENIOR (PRO-FIS-2017-01)
- Acronym
- PROA-SENIOR
- Status last verified
- Mar 2022
- First submitted
- 8 May 2018
- Last updated
- 16 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Penalva G, Crespo-Rivas JC, Guisado-Gil AB, Rodriguez-Villodres A, Pachon-Ibanez ME, Cachero-Alba B, Rivas-Romero B, Gil-Moreno J, Galva-Borras MI, Garcia-Moreno M, Salamanca-Bautista MD, Martinez-Rascon MB, Cantudo-Cuenca MR, Ninahuaman-Poma RC, Enrique-Miron MLA, Perez-Barroso A, Marin-Ariza I, Gonzalez-Florido M, Mora-Santiago MDR, Belda-Rustarazo S, Exposito-Tirado JA, Rosso-Fernandez CM, Gil-Navarro MV, Lepe-Jimenez JA, Cisneros JM; PROA-SENIOR Study Group. 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. Clin Infect Dis. 2023 Mar 4;76(5):824-832. doi: 10.1093/cid/ciac834.
PubMed 36268822
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03543605
- Acronym / sponsor ID
- PROA-SENIOR / PROA-SENIOR (PRO-FIS-2017-01)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,667 participants (actual)
- Lead sponsor
- Fundación Pública Andaluza para la gestión de la Investigación en SevillaUniversity, hospital or other
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 1 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PROA Experimental | Experimental | Behavioral: PROA ExperimentalIt 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. |
| PROA Control | Other | Other: PROA ControlThe 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Public nursing homes under the ownership of the Department of Equality and Social Policies of the Junta de Andalucía
Key exclusion criteria (1 listed)
- Nursing homes that are not under the ownership of the Department of Equality and Social Policies of the Junta de Andalucía
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PROA ExperimentalPROA Control plus clinical advice | Behavioural | PROA Experimental |
| PROA ControlPROA Control | Other | PROA Control |
Primary outcome
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
3 secondary outcomes
Antimicrobials adverse events
Time frame: 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 of infections of C. difficile
Time frame: From date of randomization, assessed monthly up to 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2022.
- Derived from this study: PubMed 36268822Penalva G, Crespo-Rivas JC, Guisado-Gil AB, Rodriguez-Villodres A, Pachon-Ibanez ME, Cachero-Alba B, Rivas-Romero B, Gil-Moreno J, Galva-Borras MI, Garcia-Moreno M, Salamanca-Bautista MD, Martinez-Rascon MB, Cantudo-Cuenca MR, Ninahuaman-Poma RC, Enrique-Miron MLA, Perez-Barroso A, Marin-Ariza I, Gonzalez-Florido M, Mora-Santiago MDR, Belda-Rustarazo S, Exposito-Tirado JA, Rosso-Fernandez CM, Gil-Navarro MV, Lepe-Jimenez JA, Cisneros JM; PROA-SENIOR Study Group. 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. Clin Infect Dis. 2023 Mar 4;76(5):824-832. doi: 10.1093/cid/ciac834.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
José Miguel Cisneros Herreros, PhD, MD principal investigator
Virgen del Rocío University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PROA Experimental in people with Human Microbiome and Antibiotic Resistant Infection, run by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Total antimicrobial pressure (time frame: From date of randomization, assessed monthly up to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03543605, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2022.