Acute Respiratory Tract InfectionsOptimAPNCT05166369
Optimisation of Antibiotic Prescription in Acute Noncomplicated Respiratory Tract Infections in Children (OptimAP Study)
A study testing Communication skills training and Mobile phone application on RTI in people with Acute Respiratory Tract Infections, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 4 sites in Spain.
Trial summary
Background: High-volume antibiotic prescribing in primary care is a major driver of antibiotic resistance. Education of physicians and patients can lower prescribing levels, but it frequently relies on highly trained staff. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Acute Respiratory Tract Infections
- What is being tested?
- Communication skills training and Mobile phone application on RTI
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 222 participants
- Where
- 4 sitesSpain
- Study dates
- 3 Jan 2022to 5 Sep 2023
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthcare professionals who care for children in primary care centres and community pharmacists of reference in four Autonomous Communities of Spain (Catalonia, Balearic Islands, Navarra and Basque Country).
Who cannot join
- None
Trial locations and contacts
4 sites in 1 country.
Spain4 sites
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Barcelona, 08041
Institut d'Investigació de les Illes Balears (IdISBa)
Palma de Mallorca, Balearic Islands, 07120
Servicio Navarro de Salud - Osasunbidea
Pamplona
Osakidetza - Ambulatorio de Pasai San Pedro
Pasaia, Gipuzkoa, 20110
About this study
Official title: Optimisation of Antibiotic Prescription in Acute Non-complicated Respiratory Tract Infections in Children: a Multicenter Factorial Randomised Controlled Trial Targeting Health Professionals and Parents.
Background: High-volume antibiotic prescribing in primary care is a major driver of antibiotic resistance. Education of physicians and patients can lower prescribing levels, but it frequently relies on highly trained staff. We will assess whether remotely delivered complex interventions including internet-based training for health care provider, and an educational intervention for parents could improve prescribing practices for respiratory tract infections (RTI) in Spain.
Methods: We will develop and evaluate the feasibility of two interventions in a 16-months randomized controlled factorial trial. Primary care (PC) centres will be allocated to one of the following four groups:
Read more
- Intervention targeting healthcare providers (paediatricians, nurses and pharmacists): i) Internet based training about communication skills and optimal antibiotic prescribing (including delayed prescribing); ii) bimonthly antibiotic prescription feedback.
- Intervention targeting parents: PC centres allocated to this group will display posters and flyers presenting a mobile app that will include information about respiratory tract infections and optimal use of antibiotics. The app can be used before, during and after the consultation, providing condition specific and patient tailored information.
- Intervention targeting both providers and parents
- No intervention.
During the trial duration we will conduct a process evaluation and a cost-effectiveness analysis. Our primary outcome will be change in the total antibiotic prescription rate. Our secondary outcomes will include: respiratory complications (e.g. pneumonia), antibiotic related adverse effects, repeated consultations, and antibiotic consumption in relation with antibiotic prescribing (delayed antibiotic prescribing). Assuming an average cluster size of 200 RTI consultations per centre, we will need to recruit 222 PC centres.
Read the detailed description
This project will evaluate the effectiveness of two complex interventions to optimize the use of antibiotics in acute uncomplicated respiratory tract infections (RTI). We will first develop the different components of the interventions and evaluate their feasibility (user testing). We will then conduct a multicenter, randomized, controlled trial to evaluate the effectiveness of the overall intervention and its two main constituents in reducing antibiotic consumption. For this reason we will implement a 2x2 factorial randomized cluster clinical trial based on healthcare practices. They will be randomized to receive the intervention targeted to parents, intervention targeted health care professionals, both interventions, or none of them. We will need to recruit a sample size of 222 primary care centres, allocated in a ratio of 1:1:1:1 to one of the four intervention groups (assuming an average cluster size of 200 RTI consultations per centre). Study setting will be defined as primary care centres in four Autonomous Communities in Spain (Catalonia, Balearic Islands, Navarra and Basque Country) with a total of more than 600 PC centers, 1,200 pediatricians, and more of one million children. Finally, during the trial duration, we will conduct a process evaluation and an economic evaluation with a cost-effectiveness analysis.
The interventions include the main characteristics of successful interventions to reduce antibiotic prescribing identified in a systematic review: engage children, occur prior to an illness episode, employ delayed prescribing, and provide guidance on specific symptoms (Andrews 2012). Furthermore, the factorial design will inform about their relative merits and the process evaluation about the potential effect of the individual components.
The research team in in Barcelona (Spain) will coordinate the overall running of the project. A research coordinator in Barcelona will run the day to day of the project from day one under the supervision of the principal investigator. The research teams in four different Spanish Autonomous Communities will contribute to all the stages (intervention development, clinical trial, and economic and process evaluation). Patient representatives will be involved in the project as co-investigators and members of the Steering Committee. Throughout the project groups of parents at each of the regions will be providing feedback.
- Conditions
- Acute Respiratory Tract Infections
- Being tested
- Communication skills training, Mobile phone application on RTI
- Keywords
- Acute respiratory tract infection, Microbial Antibiotic Resistance, Communication skills training, Mobile app-based health information and education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Communication skills trainingBehavioural
This intervention consists of a course on communication skills for healthcare professionals.
It will be done remotely via the internet and will include: communication skills training and optimal management of acute non-complicated RTI and delayed antibiotic prescription. Training modules will be delivered via a specific website password protected. Healthcare professionals will also receive a by-monthly feedback about the rate of antibiotic prescription and consumption for RTI.
Mobile phone application on RTIBehavioural
This intervention involves the use of a mobile phone application by parents and caregivers.
The mobile app will provide information, education and interactive tools about acute noncomplicated respiratory tract infections.
PC centres allocated to this group will display posters and flyers to inform parents and caregivers about the mobile app. Healthcare staff will also promote the use of this app by parents and caregivers.
The app information will be useful before the consultation, and will also allow the patient to interact with the physician during the consultation, potentially improving share decision-making.
Importantly, the app will allow tailoring the guidance provided according to the type of infection or the number of days with symptoms.
Healthcare professionals in the primary care centres allocated to this group will also receive a by-monthly feedback about the rate of antibiotic prescription and consumption for RTI.
| Study group | Role | What they receive |
|---|---|---|
| Intervention targeted to healthcare providers (paediatricians, nurses and pharmacists) (ITHP) | Experimental | Professionals in the PC centres allocated to this group will receive a complex intervention, delivered remotely, which will include the following components:
i) Web based training that will include: communication skills training and optimal management of acute non-complicated RTI, including a specific training on delayed antibiotic prescription.
ii) By-monthly feedback about the rate of antibiotic prescription and consumption for RTI, center level and individual pediatrician level (information automatically gathered from electronic health records). Receives: Behavioral: Communication skills training |
| Intervention targeted to parents (ITP) | Experimental | PC centres allocated to this group will display posters and flyers to inform parents and/or caregivers about a mobile app. It will provide detailed information about respiratory tract infections and optimal use of antibiotics. The app will include information that will be of use before the consultation, but it will also allow the patient to interact with the physician during the consultation, potentially improving share decision-making. Importantly, the app will allow tailoring the guidance provided according to the type of infection or number of days with symptoms. The app will be accessible through an app store or directly using a QR (quick response) code to facilitate uptake. Professionals in the primary care centres allocated to this group will also receive a by-monthly feedback about the rate of antibiotic prescription and consumption for RTI, at center level and individual pediatrician level (information automatically gathered from electronic health records). Receives: Behavioral: Mobile phone application on RTI |
| Intervention targeted to patients and/or patient´s parents and to the healthcare providers (ITHP*P) | Experimental | Centres allocated to this group will receive the two interventions described above (intervention targeted to parents plus intervention targeted to providers). Receives: Behavioral: Communication skills training; Behavioral: Mobile phone application on RTI |
| Control group | No intervention | The centers allocated to this arm of the study will continue with their usual care. To avoid a potential Hawthorne effect (observer effect) these centers will not be informed about their participation as controls. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total antibiotic prescription rate
Total antibiotic prescription rate for patients between 0 and 14 years old (children).
Measured: Three months (from 1st January 2022 to 31st March 2022)
Secondary outcomes (4)
RTI complication rate
Rate of clinical complications of respiratory tract infection (e.g. pneumonia, otitis media, sinusitis).
Measured: Three months (from 1st January 2022 to 31st March 2022)
Hospital admission rate due to RTI
Hospital admission rate due to a RTI or a related complication at 30 days after index RTI consultation.
Measured: Three months (from 1st January 2022 to 31st March 2022)
RTI Re-consultation rate
RTI re-consultations rates at 7, 14, or 31 days after index RTI consultation.
Measured: Three months (from 1st January 2022 to 31st March 2022)
Antibiotic-related adverse events rate
Antibiotic-related adverse events rate (as registered in clinical records).
Measured: Three months (from 1st January 2022 to 31st March 2022)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2021
- Study start3 Jan 2022
- Primary completion4 Sep 2023
- Study completion5 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Acute Respiratory Tract InfectionsStudies of the same condition, open and under way.
- More trials run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- Multicenter, cluster, randomized, factorial, controlled trial.
- Masking
- None (open label)
- Enrolment
- 222 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Fundació La Marató de TV3
- Responsible party
- Sponsor
- Investigators
- Pablo Alonso Coello, PhD, Principal investigator, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05166369
- Sponsor's protocol ID
- 19/019-P
- Acronym
- OptimAP
- Status last verified
- Sep 2023
- First submitted
- 24 Nov 2021
- Last updated
- 28 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: There is not specific individual participant data, but primary care centre data sets.
Publications
Andrews T, Thompson M, Buckley DI, Heneghan C, Deyo R, Redmond N, Lucas PJ, Blair PS, Hay AD. Interventions to influence consulting and antibiotic use for acute respiratory tract infections in children: a systematic review and meta-analysis. PLoS One. 2012;7(1):e30334. doi: 10.1371/journal.pone.0030334. Epub 2012 Jan 27.
PubMed 22299036Costelloe C, Metcalfe C, Lovering A, Mant D, Hay AD. Effect of antibiotic prescribing in primary care on antimicrobial resistance in individual patients: systematic review and meta-analysis. BMJ. 2010 May 18;340:c2096. doi: 10.1136/bmj.c2096.
PubMed 20483949Ranji SR, Steinman MA, Shojania KG, Gonzales R. Interventions to reduce unnecessary antibiotic prescribing: a systematic review and quantitative analysis. Med Care. 2008 Aug;46(8):847-62. doi: 10.1097/MLR.0b013e318178eabd.
PubMed 18665065Little P, Stuart B, Francis N, Douglas E, Tonkin-Crine S, Anthierens S, Cals JW, Melbye H, Santer M, Moore M, Coenen S, Butler C, Hood K, Kelly M, Godycki-Cwirko M, Mierzecki A, Torres A, Llor C, Davies M, Mullee M, O'Reilly G, van der Velden A, Geraghty AW, Goossens H, Verheij T, Yardley L; GRACE consortium. Effects of internet-based training on antibiotic prescribing rates for acute respiratory-tract infections: a multinational, cluster, randomised, factorial, controlled trial. Lancet. 2013 Oct 5;382(9899):1175-82. doi: 10.1016/S0140-6736(13)60994-0. Epub 2013 Jul 31.
PubMed 23915885
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimisation of Antibiotic Prescription in Acute Non-complicated Respiratory Tract Infections in Children: a Multicenter Factorial Randomised Controlled Trial Targeting Health Professionals and Parents.
- ClinicalTrials.gov ID
- NCT05166369
- Acronym / sponsor ID
- OptimAP / 19/019-P
- Conditions
- Acute Respiratory Tract Infections
- Keywords
- Acute respiratory tract infection, Microbial Antibiotic Resistance, Communication skills training, Mobile app-based health information and education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 222 participants (actual)
- Lead sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauUniversity, hospital or other
- Collaborators
- Fundació La Marató de TV3
- Study start
- 3 Jan 2022 (actual)
- Primary completion
- 4 Sep 2023 (actual)
- Study completion
- 5 Sep 2023 (actual)
- First posted
- 21 Dec 2021 (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: High-volume antibiotic prescribing in primary care is a major driver of antibiotic resistance. Education of physicians and patients can lower prescribing levels, but it frequently relies on highly trained staff. We will assess whether remotely delivered complex interventions including internet-based training for health care provider, and an educational intervention for parents could improve prescribing practices for respiratory tract infections (RTI) in Spain.
Methods: We will develop and evaluate the feasibility of two interventions in a 16-months randomized controlled factorial trial. Primary care (PC) centres will be allocated to one of the following four groups:
- Intervention targeting healthcare providers (paediatricians, nurses and pharmacists): i) Internet based training about communication skills and optimal antibiotic prescribing (including delayed prescribing); ii) bimonthly antibiotic prescription feedback.
- Intervention targeting parents: PC centres allocated to this group will display posters and flyers presenting a mobile app that will include information about respiratory tract infections and optimal use of antibiotics. The app can be used before, during and after the consultation, providing condition specific and patient tailored information.
- Intervention targeting both providers and parents
- No intervention.
During the trial duration we will conduct a process evaluation and a cost-effectiveness analysis. Our primary outcome will be change in the total antibiotic prescription rate. Our secondary outcomes will include: respiratory complications (e.g. pneumonia), antibiotic related adverse effects, repeated consultations, and antibiotic consumption in relation with antibiotic prescribing (delayed antibiotic prescribing). Assuming an average cluster size of 200 RTI consultations per centre, we will need to recruit 222 PC centres.
Detailed description
This project will evaluate the effectiveness of two complex interventions to optimize the use of antibiotics in acute uncomplicated respiratory tract infections (RTI). We will first develop the different components of the interventions and evaluate their feasibility (user testing). We will then conduct a multicenter, randomized, controlled trial to evaluate the effectiveness of the overall intervention and its two main constituents in reducing antibiotic consumption. For this reason we will implement a 2x2 factorial randomized cluster clinical trial based on healthcare practices. They will be randomized to receive the intervention targeted to parents, intervention targeted health care professionals, both interventions, or none of them. We will need to recruit a sample size of 222 primary care centres, allocated in a ratio of 1:1:1:1 to one of the four intervention groups (assuming an average cluster size of 200 RTI consultations per centre). Study setting will be defined as primary care centres in four Autonomous Communities in Spain (Catalonia, Balearic Islands, Navarra and Basque Country) with a total of more than 600 PC centers, 1,200 pediatricians, and more of one million children. Finally, during the trial duration, we will conduct a process evaluation and an economic evaluation with a cost-effectiveness analysis.
The interventions include the main characteristics of successful interventions to reduce antibiotic prescribing identified in a systematic review: engage children, occur prior to an illness episode, employ delayed prescribing, and provide guidance on specific symptoms (Andrews 2012). Furthermore, the factorial design will inform about their relative merits and the process evaluation about the potential effect of the individual components.
The research team in in Barcelona (Spain) will coordinate the overall running of the project. A research coordinator in Barcelona will run the day to day of the project from day one under the supervision of the principal investigator. The research teams in four different Spanish Autonomous Communities will contribute to all the stages (intervention development, clinical trial, and economic and process evaluation). Patient representatives will be involved in the project as co-investigators and members of the Steering Committee. Throughout the project groups of parents at each of the regions will be providing feedback.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Multicenter, cluster, randomized, factorial, controlled trial.
| Arm | Type | Receives |
|---|---|---|
| Intervention targeted to healthcare providers (paediatricians, nurses and pharmacists) (ITHP) | Experimental | Behavioral: Communication skills trainingProfessionals in the PC centres allocated to this group will receive a complex intervention, delivered remotely, which will include the following components: i) Web based training that will include: communication skills training and optimal management of acute non-complicated RTI, including a specific training on delayed antibiotic prescription. ii) By-monthly feedback about the rate of antibiotic prescription and consumption for RTI, center level and individual pediatrician level (information automatically gathered from electronic health records). |
| Intervention targeted to parents (ITP) | Experimental | Behavioral: Mobile phone application on RTIPC centres allocated to this group will display posters and flyers to inform parents and/or caregivers about a mobile app. It will provide detailed information about respiratory tract infections and optimal use of antibiotics. The app will include information that will be of use before the consultation, but it will also allow the patient to interact with the physician during the consultation, potentially improving share decision-making. Importantly, the app will allow tailoring the guidance provided according to the type of infection or number of days with symptoms. The app will be accessible through an app store or directly using a QR (quick response) code to facilitate uptake. Professionals in the primary care centres allocated to this group will also receive a by-monthly feedback about the rate of antibiotic prescription and consumption for RTI, at center level and individual pediatrician level (information automatically gathered from electronic health records). |
| Intervention targeted to patients and/or patient´s parents and to the healthcare providers (ITHP*P) | Experimental | Behavioral: Communication skills training, Behavioral: Mobile phone application on RTICentres allocated to this group will receive the two interventions described above (intervention targeted to parents plus intervention targeted to providers). |
| Control group | No intervention | –The centers allocated to this arm of the study will continue with their usual care. To avoid a potential Hawthorne effect (observer effect) these centers will not be informed about their participation as controls. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthcare professionals who care for children in primary care centres and community pharmacists of reference in four Autonomous Communities of Spain (Catalonia, Balearic Islands, Navarra and Basque Country).
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Communication skills trainingThis intervention consists of a course on communication skills for healthcare professionals. It will be done remotely via the internet and will include: communication skills training and optimal management of acute non-complicated RTI and delayed antibiotic prescription. Training modules will be delivered via a specific website password protected. Healthcare professionals will also receive a by-monthly feedback about the rate of antibiotic prescription and consumption for RTI. | Behavioural | Intervention targeted to healthcare providers (paediatricians, nurses and pharmacists) (ITHP), Intervention targeted to patients and/or patient´s parents and to the healthcare providers (ITHP*P) |
| Mobile phone application on RTIThis intervention involves the use of a mobile phone application by parents and caregivers. The mobile app will provide information, education and interactive tools about acute noncomplicated respiratory tract infections. PC centres allocated to this group will display posters and flyers to inform parents and caregivers about the mobile app. Healthcare staff will also promote the use of this app by parents and caregivers. The app information will be useful before the consultation, and will also allow the patient to interact with the physician during the consultation, potentially improving share decision-making. Importantly, the app will allow tailoring the guidance provided according to the type of infection or the number of days with symptoms. Healthcare professionals in the primary care centres allocated to this group will also receive a by-monthly feedback about the rate of antibiotic prescription and consumption for RTI. | Behavioural | Intervention targeted to parents (ITP), Intervention targeted to patients and/or patient´s parents and to the healthcare providers (ITHP*P) |
Primary outcome
Total antibiotic prescription rate
Time frame: Three months (from 1st January 2022 to 31st March 2022)
Total antibiotic prescription rate for patients between 0 and 14 years old (children).
4 secondary outcomes
RTI complication rate
Time frame: Three months (from 1st January 2022 to 31st March 2022)
Hospital admission rate due to RTI
Time frame: Three months (from 1st January 2022 to 31st March 2022)
RTI Re-consultation rate
Time frame: Three months (from 1st January 2022 to 31st March 2022)
Antibiotic-related adverse events rate
Time frame: Three months (from 1st January 2022 to 31st March 2022)
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 28 Sep 2023.
- Results publication: PubMed 22299036Andrews T, Thompson M, Buckley DI, Heneghan C, Deyo R, Redmond N, Lucas PJ, Blair PS, Hay AD. Interventions to influence consulting and antibiotic use for acute respiratory tract infections in children: a systematic review and meta-analysis. PLoS One. 2012;7(1):e30334. doi: 10.1371/journal.pone.0030334. Epub 2012 Jan 27.
- Results publication: PubMed 20483949Costelloe C, Metcalfe C, Lovering A, Mant D, Hay AD. Effect of antibiotic prescribing in primary care on antimicrobial resistance in individual patients: systematic review and meta-analysis. BMJ. 2010 May 18;340:c2096. doi: 10.1136/bmj.c2096.
- Results publication: PubMed 18665065Ranji SR, Steinman MA, Shojania KG, Gonzales R. Interventions to reduce unnecessary antibiotic prescribing: a systematic review and quantitative analysis. Med Care. 2008 Aug;46(8):847-62. doi: 10.1097/MLR.0b013e318178eabd.
- Results publication: PubMed 23915885Little P, Stuart B, Francis N, Douglas E, Tonkin-Crine S, Anthierens S, Cals JW, Melbye H, Santer M, Moore M, Coenen S, Butler C, Hood K, Kelly M, Godycki-Cwirko M, Mierzecki A, Torres A, Llor C, Davies M, Mullee M, O'Reilly G, van der Velden A, Geraghty AW, Goossens H, Verheij T, Yardley L; GRACE consortium. Effects of internet-based training on antibiotic prescribing rates for acute respiratory-tract infections: a multinational, cluster, randomised, factorial, controlled trial. Lancet. 2013 Oct 5;382(9899):1175-82. doi: 10.1016/S0140-6736(13)60994-0. Epub 2013 Jul 31.
- Individual participant dataSharing planned: Yes. There is not specific individual participant data, but primary care centre data sets.
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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.
Pablo Alonso Coello, PhD principal investigator
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Communication skills training and Mobile phone application on RTI in people with Acute Respiratory Tract Infections, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 4 sites 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 28 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
Total antibiotic prescription rate (time frame: Three months (from 1st January 2022 to 31st March 2022)). 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 NCT05166369, which also lists 4 linked publications.
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 28 Sep 2023.