Acute BronchitisNCT07383350
Improving Patient-centered Communication and Antibiotic Use With Information Sheets for Acute Respiratory Tract Infections: A Study Protocol
A study testing ARTI Info-sheets in people with Acute Bronchitis and ACUTE SINUSITIS, run by Research Unit for General Practice in Aalborg at 1 site in Denmark.
Trial summary
The goal of this trial is to investigate if the use of information sheets regarding acute respiratory tract infections will lead to more rational antibiotic prescribing and increase patient-centered communication i Danish general practice. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Bronchitis, ACUTE SINUSITIS, Sore Throat
- What is being tested?
- ARTI Info-sheets
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,144 participants
- Where
- 1 siteDenmark
- Study dates
- 5 Jan 2026to 30 Apr 2027
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Eligible patients must contact the general practice clinic with symptoms of either acute pharyngotonsillitis, acute rhinosinusitis or acute bronchitis and should be above 18 years of age.
Who cannot join
- Prior antibiotic treatment for the current episode of acute respiratory tract infections.
- Urgent need of hospitalization.
- Patients who do not understand Danish.
- Patients not listed within the general practice clinic.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Improving Patient-centered Communication and Antibiotic Use With Information Sheets for Acute Respiratory Tract Infections: Study Protocol for a Pragmatic Cluster Randomized Trial in Danish General Practice (INFO-ARTI).
The goal of this trial is to investigate if the use of information sheets regarding acute respiratory tract infections will lead to more rational antibiotic prescribing and increase patient-centered communication i Danish general practice.
The main questions to be answered:
Read more
- Will the use of information sheets lower antibiotic prescribing.
- Will the use of information sheets increase patient-centered communication.
We will compare use of information sheets in the consultation with patients with symptoms of acute respiratory tract infections to usual care (control) to find out if information sheets lower antibiotic prescribing.
Participants will be presented to the information sheets during the consultation regarding symptoms of acute respiratory tract infection.
Participants will fill in a short questionaire regarding patient-centered communication shortly after the consultation.
- Conditions
- Acute Bronchitis, ACUTE SINUSITIS, Sore Throat
- Being tested
- ARTI Info-sheets
- Keywords
- Acute respiratory tract infections, Antibiotics, General practice, Patient-centered communication, Information sheets
- Medical subject headings
- Bronchitis, Pharyngitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ARTI Info-sheetsOther
ARTI Info-sheets are three information sheets design to be used together with patients contacting general practice with symptoms of acute respiratory tract infections. The information sheets is created as a dialog-tool to increase patient involvement in managing of acute respiratory tract infections.
| Study group | Role | What they receive |
|---|---|---|
| Usual care arm | No intervention | Not described |
| ARTI Info-sheets | Active comparator | Not described Receives: Other: ARTI Info-sheets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients contacting the general practice clinic with symptoms of acute respiratory tract infections prescribed antibiotics at initial consultation.
Measured: At Initial consultation (day 0)
Secondary outcomes (6)
Proportion of patients contacting the general practice clinic with symptoms of acute respiratory tract infections with redeemed antibiotic prescriptions within 14 days after the initial consultation.
Measured: Additional contact from day 0 until day 14.
Proportion of patients contacting the general practice clinic with symptoms of acute respiratory tract infections with retrieval of prescribed antibiotics from the pharmacy within 14 days after the initial consultation.
Measured: Retrieval of prescribed antibiotic from day 0 until day 14
Proportion of patients contacting the general practice clinic with symptoms of acute respiratory tract infections reconsultation within 14 days after the initial consultation.
Measured: Reconsultation from day 0 until day 14.
Proportion of patients contacting the general practice clinic with symptoms of acute respiratory tract infections with "out of hours"-consultations within 14 days after the initial consultation.
Measured: Out of hours consultation from day 0 until day 14.
Proportion of patients contacting the general practice clinic with symptoms of acute respiratory tract infections with hospital admissions within 14 after the initial consultation.
Measured: Hospital admissions from day 0 until day 14.
Proportion of patients experiencing high level of Patient-centered communication measured by CollaboRATE.
Measured: Day 0.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2026
- Study start5 Jan 2026
- Primary completion30 Apr 2026 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute BronchitisStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Research Unit for General Practice in Aalborg
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07383350
- Sponsor's protocol ID
- 471-2
- Status last verified
- Jan 2026
- First submitted
- 26 Jan 2026
- Last updated
- 3 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Patient-centered Communication and Antibiotic Use With Information Sheets for Acute Respiratory Tract Infections: Study Protocol for a Pragmatic Cluster Randomized Trial in Danish General Practice (INFO-ARTI).
- ClinicalTrials.gov ID
- NCT07383350
- Acronym / sponsor ID
- 471-2
- Conditions
- Acute Bronchitis, ACUTE SINUSITIS, Sore Throat
- Keywords
- Acute respiratory tract infections, Antibiotics, General practice, Patient-centered communication, Information sheets
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 1,144 participants (estimated)
- Lead sponsor
- Research Unit for General Practice in AalborgUniversity, hospital or other
- Study start
- 5 Jan 2026 (actual)
- Primary completion
- 30 Apr 2026 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 3 Feb 2026 (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.
The goal of this trial is to investigate if the use of information sheets regarding acute respiratory tract infections will lead to more rational antibiotic prescribing and increase patient-centered communication i Danish general practice.
The main questions to be answered:
- Will the use of information sheets lower antibiotic prescribing.
- Will the use of information sheets increase patient-centered communication.
We will compare use of information sheets in the consultation with patients with symptoms of acute respiratory tract infections to usual care (control) to find out if information sheets lower antibiotic prescribing.
Participants will be presented to the information sheets during the consultation regarding symptoms of acute respiratory tract infection.
Participants will fill in a short questionaire regarding patient-centered communication shortly after the consultation.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual care arm | No intervention | – |
| ARTI Info-sheets | Active comparator | Other: ARTI Info-sheets |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Eligible patients must contact the general practice clinic with symptoms of either acute pharyngotonsillitis, acute rhinosinusitis or acute bronchitis and should be above 18 years of age.
Key exclusion criteria (4 listed)
- Prior antibiotic treatment for the current episode of acute respiratory tract infections.
- Urgent need of hospitalization.
- Patients who do not understand Danish.
- Patients not listed within the general practice clinic.
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 |
|---|---|---|
| ARTI Info-sheetsARTI Info-sheets are three information sheets design to be used together with patients contacting general practice with symptoms of acute respiratory tract infections. The information sheets is created as a dialog-tool to increase patient involvement in managing of acute respiratory tract infections. | Other | ARTI Info-sheets |
Primary outcome
Proportion of patients contacting the general practice clinic with symptoms of acute respiratory tract infections prescribed antibiotics at initial consultation.
Time frame: At Initial consultation (day 0)
6 secondary outcomes
Proportion of patients contacting the general practice clinic with symptoms of acute respiratory tract infections with redeemed antibiotic prescriptions within 14 days after the initial consultation.
Time frame: Additional contact from day 0 until day 14.
Proportion of patients contacting the general practice clinic with symptoms of acute respiratory tract infections with retrieval of prescribed antibiotics from the pharmacy within 14 days after the initial consultation.
Time frame: Retrieval of prescribed antibiotic from day 0 until day 14
Proportion of patients contacting the general practice clinic with symptoms of acute respiratory tract infections reconsultation within 14 days after the initial consultation.
Time frame: Reconsultation from day 0 until day 14.
Proportion of patients contacting the general practice clinic with symptoms of acute respiratory tract infections with "out of hours"-consultations within 14 days after the initial consultation.
Time frame: Out of hours consultation from day 0 until day 14.
Proportion of patients contacting the general practice clinic with symptoms of acute respiratory tract infections with hospital admissions within 14 after the initial consultation.
Time frame: Hospital admissions from day 0 until day 14.
Proportion of patients experiencing high level of Patient-centered communication measured by CollaboRATE.
Time frame: Day 0.
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 3 Feb 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ARTI Info-sheets in people with Acute Bronchitis and ACUTE SINUSITIS, run by Research Unit for General Practice in Aalborg at 1 site in Denmark.
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 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: enrolling by invitation, as of the sponsor's last update on 3 Feb 2026. 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 Denmark. 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?
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?
Proportion of patients contacting the general practice clinic with symptoms of acute respiratory tract infections prescribed antibiotics at initial consultation. (time frame: At Initial consultation (day 0)). 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 3 Feb 2026.