Respiratory Tract InfectionsISAAC-CATNCT03931577
Effectiveness of Improving Diagnostic and Communication Skills on Antibiotic Prescribing Appropriateness in Acute Cough
A study testing C-reactive protein rapid testing and Communication skill enhancement in people with Respiratory Tract Infections and Cough, run by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina at 1 site in Spain.
Trial summary
Despite their marginal benefit, about 60% of uncomplicated acute lower respiratory infections (ALRTI) are currently treated with antibiotics. Several strategies have been developed to reduce inappropriate antibiotic prescribing, with the use of point-of-care C-reactive protein (CRP) testing and the improvement of the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory Tract Infections, Cough
- What is being tested?
- C-reactive protein rapid testing and Communication skill enhancement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,940 participants
- Where
- 1 siteSpain
- Study dates
- 1 Nov 2019to 31 Dec 2021
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age equal or older than 18 years
- first consultation for acute cough (new cough or worsening of a previous cough) as the predominant symptom
- of up to 3 weeks' duration
- which the clinician believes to be an infectious acute lower respiratory tract infection
Who cannot join
- a working diagnosis of a non-infective disorder, such as heart failure, pulmonary embolus, oesophageal reflux, or allergy
- use of antibiotics in the previous two weeks
- immunological deficiencies, and/or
- inability to provide informed consent or unable to follow the study procedures
Trial locations and contacts
1 site in 1 country.
Spain1 site
La Marina Health Center
Barcelona, Catalonia, 08038
Josep M Cots, MD PhD, 0034601381364 ext. 0034601381364, 23465jcy@comb.cat
About this study
Official title: Effectiveness and Cost-effectiveness of Improving Clinicians' Diagnostic and Communication Skills on Antibiotic Prescribing Appropriateness in Patients With Acute Cough in Primary Care in Catalonia.
Despite their marginal benefit, about 60% of uncomplicated acute lower respiratory infections (ALRTI) are currently treated with antibiotics. Several strategies have been developed to reduce inappropriate antibiotic prescribing, with the use of point-of-care C-reactive protein (CRP) testing and the improvement of the communication skills being the most effective interventions, but most of the studies have been carried out outside Mediterranean countries. This study is aimed at evaluating the effect of a disease-focused intervention (CRP) and an illness-focused intervention (improvement of communication skills to optimise doctor-patient consultations and share-decision making with the aid of patient-centred leaflets) on antibiotic prescribing for patients with ALRTIs in Catalan primary care by means of a cluster, randomised, factorial, controlled trial. Primary care centres will be assigned to four trial arms: usual care, use of CRP testing, enhanced communication skills backed up with leaflets, or combined interventions. The main outcome will be antibiotic use within the first 6 weeks and the quality adjusted life years. A pharmacoeconomic analysis of the impact of these interventions will be assessed.
Read the detailed description
Background: Most antibiotics are prescribed in primary care, and most commonly for acute lower respiratory infections (ALRTI). Despite their marginal benefit, about 60% of these infections are currently treated with antibiotics in Catalonia, Spain. Several strategies have been developed to reduce inappropriate antibiotic prescribing, with the use of C-reactive protein (CRP) rapid testing and the improvement of the communication skills being the most effective interventions. However, most studies have been carried out outside Mediterranean countries. This study aims to evaluate the effectiveness and the efficiency of a continuous disease-focused intervention (CRP) and an illness-focused intervention (enhancement of communication skills to optimise doctor-patient consultations and share decision making with the aid of patient-centred leaflets) on antibiotic prescribing in patients with ALRTIs in Catalan primary care centres.
Methods/design: A cluster, randomised, factorial, controlled trial aimed at including 20 primary care centres (n=2,940 patients) with patients older than 18 years presenting for a first consultation with ALRTI, therefore with presence of infected acute cough of up to 3 weeks' duration as the predominant symptom. Centres, according to socioeconomic and antibiotic consumption, will be randomly assigned according to hierarchical clustering to any of four trial arms: usual care, CRP testing, enhanced communication skills backed up with patient leaflets, or combined interventions. A cost-effectiveness and cost-utility analysis will be performed from the perspective of public health system. A qualitative study aimed at identifying the expectations and concerns in patients with ALRTIs and the satisfaction of clinicians with the different interventions will also be performed. Clinicians assigned to the interventions will participate in a 2-hour training workshop before the inception of the trial and will receive a monthly intervention-tailored training module during the trial. Clinical effectiveness will be measured by the antibiotic use within the first 6 weeks and the quality adjusted life years and secondary outcomes will be duration of illness and severity of cough measured with a symptom diary, healthcare reconsultations, hospital admissions and complications. National health care perspective will be adopted and the temporal horizon of the analysis will be one year. Health care costs will be considered and expressed in € of the current year of the analysis. Univariate and multivariate sensitivity analysis will be carried out.
Discussion: The ISAAC-CAT project aims to improve the management of ALRTIs in primary care through use of two different clinicians' skills to help target antibiotic prescribing only to those most likely to benefit, and thereby reduce the risk of unnecessary exposure to antibiotics leading to adverse effects and/or the development of AMR without having a negative impact on health status, thus benefiting individual patients and society at large. This project will contribute to evaluate the effectiveness and efficiency of different strategies for more appropriate antibiotic prescribing that are currently out of the scope of the actual guidelines.
- Conditions
- Respiratory Tract Infections, Cough
- Being tested
- C-reactive protein rapid testing, Communication skill enhancement
- Keywords
- Antimicrobial Stewardship, Cost-Benefit Analysis, Anti-Bacterial Agents, Primary Health Care
- Medical subject headings
- Respiratory Tract Infections, Cough
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
C-reactive protein rapid testingDiagnostic test
Also called CRP
Continuous (workshop and monthly web-based training) disease-focused intervention with the provision of CRP rapid testing in the primary care practices.
Communication skill enhancementProcedure or surgery
Also called Leaflet provision
Continuous (on-site and monthly online training) illness-focused intervention (enhancement of communication skills to optimise doctor-patient consultations and share decision making with the aid of patient-centred leaflets) in the primary care practices.
| Study group | Role | What they receive |
|---|---|---|
| C-reactive protein rapid testing | Experimental | Continuous (workshop and monthly web-based training) disease-focused intervention with the use of C-reactive protein rapid testing. Receives: Diagnostic Test: C-reactive protein rapid testing |
| Enhancement of communication skills | Experimental | Continuous (on-site and monthly online training) illness-focused intervention with enhancement of communication skills to optimise doctor-patient consultations and share decision making with the aid of patient-centred leaflets. Receives: Procedure: Communication skill enhancement |
| C-reactive protein + communication skills | Experimental | Continuous (workshop and monthly web-based training) disease-focused intervention with C-reactive protein rapid testing and on-site and continuous (monthly online training illness-focused intervention) with enhancement of communication skills to optimise doctor-patient consultations and share decision making with the aid of patient-centred leaflets. Receives: Diagnostic Test: C-reactive protein rapid testing; Procedure: Communication skill enhancement |
| Usual care | No intervention | Usual care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Antibiotic use
Number of antibiotics consumed (as documented in the CRFs and double-checked by the Pharmacy Unit of Institut Català de Salut that can track if the antibiotic has been dispensed at any of the Catalan pharmacies)
Measured: Day 42
Health status
Quality of life score obtained using the EuroQol questionnaire
Measured: Difference between baseline visit and day 42
Secondary outcomes (10)
Re-consultations and complications
Number of re-consultation for new or worsening symptoms, new signs, or hospital admission, assessed by review of medical notes (practice staff, the local study team, or both using a standard form to report these data), and Number of complications regarding the ALRTI
Measured: Day 42
Duration of symptoms and duration of severe symptoms
Number of days until symptoms are rated daily as 0 (no problem) (information is reported by patients in self-completed diaries)
Measured: Day 42
Antibiotic prescription at the baseline visit
Number of antibiotic prescriptions at the baseline visit, differentiating immediate and delayed antibiotic prescribing, and antibiotic dispensing at the pharmacies
Measured: Baseline visit
Drugs other than antibiotics
Number of non-antibiotic prescriptions (reported by patients in self-completed diaries)
Measured: Day 42
Tests ordered by clinicians
Number of tests ordered by clinicians (reported in the CRF)
Measured: Day 42
Patient satisfaction with care
Patient satisfaction score reported in the symptom diary. Measured with a question that has used in previous studies: How satisfied are you with the consultation? Range from 0 (nothing satisfied) to 5 (extremely satisfied).
Measured: Day 14
Patient perception of the usefulness of the information received.
Patient perception score about the usefulness of the information received. Measured with a question that has used in previous studies: Do you consider that the information received from your doctor has been useful? Range from 0 (nothing useful) to 5 (extremely useful).
Measured: Day 14
Patient future consulting intention
Patient future consulting intention score. Measured with a question that has used in previous studies: Do you think you will attend the doctor in future occasions in case you present the same symptoms? Range from 0 (totally unlikely) to 5 (sure).
Measured: Day 14
Serious adverse events
Number of serious adverse events (assessed by review of medical notes (practice staff, the local study team, or both using a standard form to report these data)
Measured: Day 42
Absenteeism
Number of days of sick leave (collected in the CRFs)
Measured: Baseline visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2019
- Study start1 Nov 2019 (estimated)
- Primary completion28 Feb 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Respiratory Tract 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- Cluster randomised factorial controlled trial.
- Masking
- None (open label)
- Enrolment
- 2,940 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
- Sponsor type
- University, hospital or other
- Collaborators
- Universitat Internacional de Catalunya, Fundacio d'Atencio Primaria, Universitat Pompeu Fabra
- Responsible party
- Sponsor
- Investigators
- Rosa Morros, MD PhD, Study chair, Clinical pharmacologist
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03931577
- Sponsor's protocol ID
- P18/227
- Acronym
- ISAAC-CAT
- Status last verified
- Apr 2019
- First submitted
- 8 Apr 2019
- Last updated
- 30 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Reposition in SCENTIA
Publications
Medina-Perucha L, Garcia-Sangenis A, Moragas A, Galvez-Hernandez P, Cots JM, Lanau-Roig A, Borras A, Amo I, Monfa R, Llor C, Berenguera A. Autonomy, power dynamics and antibiotic use in primary healthcare: A qualitative study. PLoS One. 2020 Dec 18;15(12):e0244432. doi: 10.1371/journal.pone.0244432. eCollection 2020.
PubMed 33338078Ruiz R, Moragas A, Trapero-Bertran M, Siso A, Berenguera A, Oliva G, Borras-Santos A, Garcia-Sangenis A, Puig-Junoy J, Cots JM, Morros R, Mora T, Lanau-Roig A, Monfa R, Troncoso A, Abellana RM, Galvez P, Medina-Perucha L, Bjerrum L, Amo I, Barragan N, Llor C. Effectiveness and cost-effectiveness of Improving clinicians' diagnostic and communication Skills on Antibiotic prescribing Appropriateness in patients with acute Cough in primary care in CATalonia (the ISAAC-CAT study): study protocol for a cluster randomised controlled trial. Trials. 2019 Dec 17;20(1):740. doi: 10.1186/s13063-019-3727-3.
PubMed 31847912
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Cost-effectiveness of Improving Clinicians' Diagnostic and Communication Skills on Antibiotic Prescribing Appropriateness in Patients With Acute Cough in Primary Care in Catalonia.
- ClinicalTrials.gov ID
- NCT03931577
- Acronym / sponsor ID
- ISAAC-CAT / P18/227
- Conditions
- Respiratory Tract Infections, Cough
- Keywords
- Antimicrobial Stewardship, Cost-Benefit Analysis, Anti-Bacterial Agents, Primary Health Care
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2,940 participants (estimated)
- Lead sponsor
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i GurinaUniversity, hospital or other
- Collaborators
- Universitat Internacional de Catalunya, Fundacio d'Atencio Primaria, Universitat Pompeu Fabra
- Study start
- 1 Nov 2019 (estimated)
- Primary completion
- 28 Feb 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 30 Apr 2019 (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.
Despite their marginal benefit, about 60% of uncomplicated acute lower respiratory infections (ALRTI) are currently treated with antibiotics. Several strategies have been developed to reduce inappropriate antibiotic prescribing, with the use of point-of-care C-reactive protein (CRP) testing and the improvement of the communication skills being the most effective interventions, but most of the studies have been carried out outside Mediterranean countries. This study is aimed at evaluating the effect of a disease-focused intervention (CRP) and an illness-focused intervention (improvement of communication skills to optimise doctor-patient consultations and share-decision making with the aid of patient-centred leaflets) on antibiotic prescribing for patients with ALRTIs in Catalan primary care by means of a cluster, randomised, factorial, controlled trial. Primary care centres will be assigned to four trial arms: usual care, use of CRP testing, enhanced communication skills backed up with leaflets, or combined interventions. The main outcome will be antibiotic use within the first 6 weeks and the quality adjusted life years. A pharmacoeconomic analysis of the impact of these interventions will be assessed.
Detailed description
Background: Most antibiotics are prescribed in primary care, and most commonly for acute lower respiratory infections (ALRTI). Despite their marginal benefit, about 60% of these infections are currently treated with antibiotics in Catalonia, Spain. Several strategies have been developed to reduce inappropriate antibiotic prescribing, with the use of C-reactive protein (CRP) rapid testing and the improvement of the communication skills being the most effective interventions. However, most studies have been carried out outside Mediterranean countries. This study aims to evaluate the effectiveness and the efficiency of a continuous disease-focused intervention (CRP) and an illness-focused intervention (enhancement of communication skills to optimise doctor-patient consultations and share decision making with the aid of patient-centred leaflets) on antibiotic prescribing in patients with ALRTIs in Catalan primary care centres.
Methods/design: A cluster, randomised, factorial, controlled trial aimed at including 20 primary care centres (n=2,940 patients) with patients older than 18 years presenting for a first consultation with ALRTI, therefore with presence of infected acute cough of up to 3 weeks' duration as the predominant symptom. Centres, according to socioeconomic and antibiotic consumption, will be randomly assigned according to hierarchical clustering to any of four trial arms: usual care, CRP testing, enhanced communication skills backed up with patient leaflets, or combined interventions. A cost-effectiveness and cost-utility analysis will be performed from the perspective of public health system. A qualitative study aimed at identifying the expectations and concerns in patients with ALRTIs and the satisfaction of clinicians with the different interventions will also be performed. Clinicians assigned to the interventions will participate in a 2-hour training workshop before the inception of the trial and will receive a monthly intervention-tailored training module during the trial. Clinical effectiveness will be measured by the antibiotic use within the first 6 weeks and the quality adjusted life years and secondary outcomes will be duration of illness and severity of cough measured with a symptom diary, healthcare reconsultations, hospital admissions and complications. National health care perspective will be adopted and the temporal horizon of the analysis will be one year. Health care costs will be considered and expressed in € of the current year of the analysis. Univariate and multivariate sensitivity analysis will be carried out.
Discussion: The ISAAC-CAT project aims to improve the management of ALRTIs in primary care through use of two different clinicians' skills to help target antibiotic prescribing only to those most likely to benefit, and thereby reduce the risk of unnecessary exposure to antibiotics leading to adverse effects and/or the development of AMR without having a negative impact on health status, thus benefiting individual patients and society at large. This project will contribute to evaluate the effectiveness and efficiency of different strategies for more appropriate antibiotic prescribing that are currently out of the scope of the actual guidelines.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Cluster randomised factorial controlled trial.
| Arm | Type | Receives |
|---|---|---|
| C-reactive protein rapid testing | Experimental | Diagnostic Test: C-reactive protein rapid testingContinuous (workshop and monthly web-based training) disease-focused intervention with the use of C-reactive protein rapid testing. |
| Enhancement of communication skills | Experimental | Procedure: Communication skill enhancementContinuous (on-site and monthly online training) illness-focused intervention with enhancement of communication skills to optimise doctor-patient consultations and share decision making with the aid of patient-centred leaflets. |
| C-reactive protein + communication skills | Experimental | Diagnostic Test: C-reactive protein rapid testing, Procedure: Communication skill enhancementContinuous (workshop and monthly web-based training) disease-focused intervention with C-reactive protein rapid testing and on-site and continuous (monthly online training illness-focused intervention) with enhancement of communication skills to optimise doctor-patient consultations and share decision making with the aid of patient-centred leaflets. |
| Usual care | No intervention | –Usual care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- age equal or older than 18 years
- first consultation for acute cough (new cough or worsening of a previous cough) as the predominant symptom
- of up to 3 weeks' duration
- which the clinician believes to be an infectious acute lower respiratory tract infection
Key exclusion criteria (4 listed)
- a working diagnosis of a non-infective disorder, such as heart failure, pulmonary embolus, oesophageal reflux, or allergy
- use of antibiotics in the previous two weeks
- immunological deficiencies, and/or
- inability to provide informed consent or unable to follow the study procedures
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 |
|---|---|---|
| C-reactive protein rapid testingAlso: CRPContinuous (workshop and monthly web-based training) disease-focused intervention with the provision of CRP rapid testing in the primary care practices. | Diagnostic test | C-reactive protein + communication skills, C-reactive protein rapid testing |
| Communication skill enhancementAlso: Leaflet provisionContinuous (on-site and monthly online training) illness-focused intervention (enhancement of communication skills to optimise doctor-patient consultations and share decision making with the aid of patient-centred leaflets) in the primary care practices. | Procedure or surgery | C-reactive protein + communication skills, Enhancement of communication skills |
Primary outcome
Antibiotic use
Time frame: Day 42
Number of antibiotics consumed (as documented in the CRFs and double-checked by the Pharmacy Unit of Institut Català de Salut that can track if the antibiotic has been dispensed at any of the Catalan pharmacies)
Health status
Time frame: Difference between baseline visit and day 42
Quality of life score obtained using the EuroQol questionnaire
10 secondary outcomes
Re-consultations and complications
Time frame: Day 42
Duration of symptoms and duration of severe symptoms
Time frame: Day 42
Antibiotic prescription at the baseline visit
Time frame: Baseline visit
Drugs other than antibiotics
Time frame: Day 42
Tests ordered by clinicians
Time frame: Day 42
Patient satisfaction with care
Time frame: Day 14
Patient perception of the usefulness of the information received.
Time frame: Day 14
Patient future consulting intention
Time frame: Day 14
Serious adverse events
Time frame: Day 42
Absenteeism
Time frame: Baseline visit
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2019.
- Derived from this study: PubMed 33338078Medina-Perucha L, Garcia-Sangenis A, Moragas A, Galvez-Hernandez P, Cots JM, Lanau-Roig A, Borras A, Amo I, Monfa R, Llor C, Berenguera A. Autonomy, power dynamics and antibiotic use in primary healthcare: A qualitative study. PLoS One. 2020 Dec 18;15(12):e0244432. doi: 10.1371/journal.pone.0244432. eCollection 2020.
- Derived from this study: PubMed 31847912Ruiz R, Moragas A, Trapero-Bertran M, Siso A, Berenguera A, Oliva G, Borras-Santos A, Garcia-Sangenis A, Puig-Junoy J, Cots JM, Morros R, Mora T, Lanau-Roig A, Monfa R, Troncoso A, Abellana RM, Galvez P, Medina-Perucha L, Bjerrum L, Amo I, Barragan N, Llor C. Effectiveness and cost-effectiveness of Improving clinicians' diagnostic and communication Skills on Antibiotic prescribing Appropriateness in patients with acute Cough in primary care in CATalonia (the ISAAC-CAT study): study protocol for a cluster randomised controlled trial. Trials. 2019 Dec 17;20(1):740. doi: 10.1186/s13063-019-3727-3.
- Individual participant dataSharing planned: Yes. Reposition in SCENTIA
Related trials for Respiratory Tract Infections
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
RecruitingObservational study
VIRal Pulmonary Infections in Older AGE
Viral Pulmonary Infections
Not yet recruitingPhase 2/3
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
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.
Rosa Morros, MD PhD study chair
Clinical pharmacologist
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing C-reactive protein rapid testing and Communication skill enhancement in people with Respiratory Tract Infections and Cough, run by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina 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 4 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 30 Apr 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ana Moragas, MD PhD (0034600072170 ext. 0034600072170, anamaria.moragas@urv.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Antibiotic use (time frame: Day 42). The study lists 2 primary outcomes in all. 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 NCT03931577, which also lists 2 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 30 Apr 2019.