Community Acquired InfectionsTELÉMACONCT06706583
Clinical and Ecological Impact of a Primary Care Antimicrobial Stewardship Program Based on Telematic Educational Interviews (TELÉMACO Trial)
A study testing Telematic educational interviews + standard training and Standard training in people with Community Acquired Infections, run by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla at 1 site in Spain.
Trial summary
Brief Summary: Open-label, cluster randomized, multicenter clinical trial to evaluate the clinical and ecological impact of a Primary Care ASP based on telematic educational interviews. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Community Acquired Infections
- What is being tested?
- Telematic educational interviews + standard training and Standard training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSpain
- Study dates
- 1 Dec 2024to 31 Mar 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Primary Care centres within the reference area of the University Hospital Virgen del Rocío.
Who cannot join
- Emergency departments.
- Odontology offices.
- DDD per Health centre less than 5.78
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Jose Molina Gil-Bermejo, MD-PhD contact
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitario Virgen del Rocío
Seville, 41013
Jose Molina Gil-Bermejo, MD-PhD, josemolinagb@gmail.com
Jose Molina Gil-Bermejo
About this study
Official title: Clinical and Ecological Impact of a Primary Care Antimicrobial Stewardship Program Based on Telematic Educational Interviews. A Cluster Randomized Clinical Trial (TELÉMACO Trial)
Brief Summary: Open-label, cluster randomized, multicenter clinical trial to evaluate the clinical and ecological impact of a Primary Care ASP based on telematic educational interviews.
Read the detailed description
The objective of this project is to measure the effect of an Antimicrobial Stewardship Program (ASP) in Primary Care, based on an educational intervention.
This will consist of periodic structured telematic educational interviews between Infectious Diseases experts and Family Medicine and paediatrics specialists. In these interviews, the principles for the optimal use of antimicrobials will be addressed on real cases, analyzing together prescriptions randomly chosen from the Primary Care physician himself.
The repetition over time of key pedagogical messages for the optimisation of prescriptions is expected to improve the quality of antibiotic use, reduce the overall consumption, improve the use of microbiological tests, reduce the incidence of community infections caused by resistant microorganisms, and preserve patients' safety measured by the rate of admission for serious infections.
The results derived from these educational interventions, in the framework of a multimodal ASP, have been evaluated in hospital and Primary Care settings in quasi-experimental studies with a favourable outcome, but not in a clinical trial that specifically assesses the efficacy of educational interviews and avoids the bias of uncontrolled studies. To demonstrate this hypothesis, a cluster randomized trial has been designed, in wich all healthcare centers will be assigned either to a control group (the standard measures defined by the regional ASP PIRASOA will be maintained), and an experimental group (whose physicians will receive the educational intervention described).
- Conditions
- Community Acquired Infections
- Being tested
- Telematic educational interviews + standard training, Standard training
- Keywords
- Antimicrobial Stewardship Program (ASP), Primary Care, Telemedicine, PIRASOA
- Medical subject headings
- Community-Acquired Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telematic educational interviews + standard trainingBehavioural
Physicians attending at healthcare centers in the experimental arm will receive periodic telematic educational interviews in which an Infectious Diseases consultant will provide practical training on the appropriate use of antibiotics through the review of one of the physician´s randomly chosen antibiotic prescription, according to a structured brief interview.
In addition to this, each of these centres will continue carrying out the already established activities of the Regional ASP (PIRASOA).
Standard trainingBehavioural
Primary Care Health Centers assigned to the control group will receive standard educational activities designated by the current Regional ASP (PIRASOA).
| Study group | Role | What they receive |
|---|---|---|
| Enhanced education arm | Experimental | Telematic educational interviews are added to standard PIRASOA training Receives: Behavioral: Telematic educational interviews + standard training |
| Standard education arm | Active comparator | Only standard PIRASOA training is provided Receives: Behavioral: Standard training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total antimicrobial consumption
Total antimicrobial antimicrobial will be measured using the recommended international standard, the Defined Daily Dose (DDD) per 1000 inhabitants per day.
Predefined subgroup analyses will be conducted to assess the intervention\'s effect on the primary outcome based on: patient age, geneder, and socioeconomic level.
Measured: Monthly over a 36-month period
Secondary outcomes (3)
Adequacy of antimicrobial prescriptions
The rate of appropriate antimicrobial prescriptions according to national reference guidelines will be assessed through three point prevalence surveys of randomly selected prescriptions.
Measured: Prevalence surveys will be performed at months +0, +7 and +15.
Incidence density of hospitalizations due to infections
The incidence density of hospitalizations due to infections (urinary, pneumonia and skin and soft tissue infections), and specifically due to Clostridiodes difficile infections per inhabitant.
Measured: Monthly, over a 36-month period.
Incidence density of resistant Enterobacterales in urine cultures
Incidence density of resistant Enterobacterales in urine cultures per inhabitant sent from Primary Care centers from both arms.
Measured: Monthly, over a 36-month period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2024
- Study start1 Dec 2024 (estimated)
- Primary completion31 Mar 2026 (estimated)
- Study completion31 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Community Acquired InfectionsStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Cluster randomized clinical trial
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
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, MD-PhD, Study director, Hospitales Universitarios Virgen del Rocío
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06706583
- Sponsor's protocol ID
- TELÉMACO
- Acronym
- TELÉMACO
- Status last verified
- Nov 2024
- First submitted
- 22 Nov 2024
- Last updated
- 26 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Ecological Impact of a Primary Care Antimicrobial Stewardship Program Based on Telematic Educational Interviews. A Cluster Randomized Clinical Trial (TELÉMACO Trial)
- ClinicalTrials.gov ID
- NCT06706583
- Acronym / sponsor ID
- TELÉMACO / TELÉMACO
- Conditions
- Community Acquired Infections
- Keywords
- Antimicrobial Stewardship Program (ASP), Primary Care, Telemedicine, PIRASOA
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Fundación Pública Andaluza para la gestión de la Investigación en SevillaUniversity, hospital or other
- Study start
- 1 Dec 2024 (estimated)
- Primary completion
- 31 Mar 2026 (estimated)
- Study completion
- 31 Mar 2026 (estimated)
- First posted
- 26 Nov 2024 (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.
Brief Summary: Open-label, cluster randomized, multicenter clinical trial to evaluate the clinical and ecological impact of a Primary Care ASP based on telematic educational interviews.
Detailed description
The objective of this project is to measure the effect of an Antimicrobial Stewardship Program (ASP) in Primary Care, based on an educational intervention.
This will consist of periodic structured telematic educational interviews between Infectious Diseases experts and Family Medicine and paediatrics specialists. In these interviews, the principles for the optimal use of antimicrobials will be addressed on real cases, analyzing together prescriptions randomly chosen from the Primary Care physician himself.
The repetition over time of key pedagogical messages for the optimisation of prescriptions is expected to improve the quality of antibiotic use, reduce the overall consumption, improve the use of microbiological tests, reduce the incidence of community infections caused by resistant microorganisms, and preserve patients' safety measured by the rate of admission for serious infections.
The results derived from these educational interventions, in the framework of a multimodal ASP, have been evaluated in hospital and Primary Care settings in quasi-experimental studies with a favourable outcome, but not in a clinical trial that specifically assesses the efficacy of educational interviews and avoids the bias of uncontrolled studies. To demonstrate this hypothesis, a cluster randomized trial has been designed, in wich all healthcare centers will be assigned either to a control group (the standard measures defined by the regional ASP PIRASOA will be maintained), and an experimental group (whose physicians will receive the educational intervention described).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Cluster randomized clinical trial
| Arm | Type | Receives |
|---|---|---|
| Enhanced education arm | Experimental | Behavioral: Telematic educational interviews + standard trainingTelematic educational interviews are added to standard PIRASOA training |
| Standard education arm | Active comparator | Behavioral: Standard trainingOnly standard PIRASOA training is provided |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Primary Care centres within the reference area of the University Hospital Virgen del Rocío.
Key exclusion criteria (3 listed)
- Emergency departments.
- Odontology offices.
- DDD per Health centre less than 5.78
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 |
|---|---|---|
| Telematic educational interviews + standard trainingPhysicians attending at healthcare centers in the experimental arm will receive periodic telematic educational interviews in which an Infectious Diseases consultant will provide practical training on the appropriate use of antibiotics through the review of one of the physician´s randomly chosen antibiotic prescription, according to a structured brief interview. In addition to this, each of these centres will continue carrying out the already established activities of the Regional ASP (PIRASOA). | Behavioural | Enhanced education arm |
| Standard trainingPrimary Care Health Centers assigned to the control group will receive standard educational activities designated by the current Regional ASP (PIRASOA). | Behavioural | Standard education arm |
Primary outcome
Total antimicrobial consumption
Time frame: Monthly over a 36-month period
Total antimicrobial antimicrobial will be measured using the recommended international standard, the Defined Daily Dose (DDD) per 1000 inhabitants per day. Predefined subgroup analyses will be conducted to assess the intervention\'s effect on the primary outcome based on: patient age, geneder, and socioeconomic level.
3 secondary outcomes
Adequacy of antimicrobial prescriptions
Time frame: Prevalence surveys will be performed at months +0, +7 and +15.
Incidence density of hospitalizations due to infections
Time frame: Monthly, over a 36-month period.
Incidence density of resistant Enterobacterales in urine cultures
Time frame: Monthly, over a 36-month period.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2024.
- Individual participant dataSharing planned: Yes
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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.
Jose Molina Gil-Bermejo, MD-PhD contact
José Miguel Cisneros Herreros, MD-PhD study director
Hospitales Universitarios Virgen del Rocío
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telematic educational interviews + standard training and Standard training in people with Community Acquired Infections, 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 3 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: looking for participants now, as of the sponsor's last update on 26 Nov 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clara M Rosso Fernández, MD-PhD (+34955013414, claram.rosso.sspa@juntadeandalucia.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total antimicrobial consumption (time frame: Monthly over a 36-month period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Nov 2024.