Acute Respiratory Tract InfectionPhase 4STORMNCT06581367
Tailoring Antibiotic Duration for Respiratory Tract Infections in Primary Care
A Phase 4 study testing Tailoring the course duration to the patient's needs. and Complete a 7-day course in people with Acute Respiratory Tract Infection, run by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina.
Trial summary
The rise of drug-resistant organisms and the need to minimize side effects calls for a new approach to antibiotic therapy duration. This study explores tailoring the length of antibiotic treatment to patient recovery, focusing on whether adjusting therapy based on when the patient feels better is as effective as… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Acute Respiratory Tract Infection
- What is being tested?
- Tailoring the course duration to the patient's needs. and Complete a 7-day course
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 474 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2025to 30 Apr 2027
- Phase
- Phase 4
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Either adults with a) acute cough (new cough or worsening of a previous cough) as the predominant symptom which the clinician believes to be a bacterial acute lower RTI, such as community-acquired pneumonia, acute bronchitis or acute chronic obstructive pulmonary disease (COPD) exacerbations, or b) an acute bacterial rhinosinusitis
- Doctors deem beta-lactam therapy (given every eight hours for a minimum of seven days) is necessary
Who cannot join
- RTIs different from a lower RTI or acute rhinosinusitis
- Patients with suspected septicemia (quick Quick Sequential Organ Failure Assessment: respiratory rate ≥22 breaths/minute, systolic blood pressure <100 mm Hg or altered mental status with a Glasgow score < 5) ≥2
- Patients with pneumonia and [Confusion, respiratory rate ≥30 breaths/minute, blood pressure < 90/60 mm Hg, or age >65 yr.] ≥1
- Patients with very severe COPD (Forced Expiratory Volume in One Second <30%)
- Patients with COPD who have taken four or more antibiotic courses in the previous year, presence of significant bronchiectasis, and/or isolation of Pseudomonas in a previous sputum culture
- Patients with reported allergy to beta-lactams
Show all 16Show fewer
- Patients who have taken an antibiotic in the previous two weeks
- Patients who have been hospitalized in the last two weeks
- A working diagnosis of a non-infective disorder, such as heart failure, pulmonary embolus, esophageal reflux
- Immunocompromised patients, such as HIV infection, patients taking immunosuppressive treatment, antineoplastic therapy, or systemic corticosteroids
- Currently participating in another clinical trial
- Previously participated in the STORM study
- Active neoplasia
- Terminal illness
- Institutionalized patient
- Inability/unable to understand and/or take part in the clinical trial
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Tailoring Antibiotic Duration for Respiratory Tract Infections in Primary Care: a Pragmatic Randomized Controlled Trial
The rise of drug-resistant organisms and the need to minimize side effects calls for a new approach to antibiotic therapy duration. This study explores tailoring the length of antibiotic treatment to patient recovery, focusing on whether adjusting therapy based on when the patient feels better is as effective as completing the prescribed course for acute respiratory tract infections (RTIs). The investigators will enroll 474 outpatients aged 18-75 with acute RTIs across 25 Spanish healthcare centers. Patients will be randomized into two groups: one following standard full-course antibiotic therapy, and another receiving a tailored approach, where treatment may be shortened based on clinical assessments. The primary outcome is clinical efficacy at day 14. Secondary outcomes include antibiotic duration, complications, and quality of life.
Read the detailed description
Background. Combating the rise of drug-resistant organisms and minimizing the side effects demand a shift in how we approach antibiotic therapy duration. A study focused on tailoring antibiotic length of therapy to patients\' needs as soon as they feel better, is a promising strategy. The investigators aim to assess whether adjusting the duration of antibiotic therapy according to individual patient needs, shortening it to the time when the patient feels better, proves as effective as completing the antibiotic course in acute respiratory tract infections (RTIs).
Methods. The investigators plan to enroll a minimum of 474 outpatients ranging from 18 to 75 years of age with clinical features of acute RTIs across 25 Spanish primary healthcare centers. Patients diagnosed with acute lower RTIs or acute rhinosinusitis, deemed by clinicians to require a beta-lactam course, will be randomized to either usual care, involving a full-course antibiotic therapy based on current guidelines, or a tailored approach. In the intervention group, patients will be advised to visit the center as soon as they feel better and are afebrile for a clinical assessment and C-reactive protein rapid testing after completing two full days of antibiotic. Treatment will be discontinued if these clinical results are normal. The primary outcome will be overall clinical efficacy at day 14, while secondary outcomes include duration, doses of antibiotic taken, complications and reattendance within the first month, drug-related adverse events, antibiotic given, other therapies, days of severe and moderate symptoms, days of symptoms, absenteeism and health-related quality of life. All participants will be given a symptom diary, recording their symptoms each evening. Additionally, a cost-effectiveness study and qualitative studies involving clinicians and patients aimed at exploring the strategy\'s pros, cons, uptake, and satisfaction levels will be carried out.
Discussion. The investigators will examine whether adults who present with symptoms of acute lower RTI or rhinosinusitis in general practice, who are treated with antibiotic courses until they feel better are as effective as longer standard courses. It is highly important that a possible reduction in the antibiotic course as soon as the patient feels better does not compromise patients' recovery or clinical course, which we will assess closely. This comprehensive approach aims to shed light on the practicality and impact of tailoring antibiotic duration in RTIs.
- Conditions
- Acute Respiratory Tract Infection
- Being tested
- Tailoring the course duration to the patient's needs., Complete a 7-day course
- Keywords
- Antibacterial Agents Antimicrobial Resistance, Duration, Primary Health Care, Personalized Medicine, Drugs, Customized, Drug Resistance, Microbial, Patient-Centered Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tailoring the course duration to the patient's needs.Drug
Also called Patient-centered approach
Patients will be advised to visit the center as soon as they feel better and are afebrile for a clinical assessment including vital signs (temperature, blood pressure, respiratory rate, pulse, and oxygen saturation) and C-reactive protein rapid testing after completing two full days of antibiotic.
Complete a 7-day courseDrug
Also called Completion of the antibiotic course
The antibiotic course must be completed (7 days at least).
| Study group | Role | What they receive |
|---|---|---|
| Control group | Placebo comparator | Full-course antibiotic therapy based on current guidelines (7 days). Receives: Drug: Complete a 7-day course |
| Intervention group | Active comparator | In the intervention group, patients will be advised to visit the center as soon as they feel better and are afebrile for a clinical assessment and C-reactive protein rapid testing after completing two full days of antibiotic. Receives: Drug: Tailoring the course duration to the patient's needs. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical resolution
Number of patients with disappearance of fever, disappearance or improvement in overall condition (all scores <2), such that no additional antimicrobial treatment is necessary.
Measured: Day 14
Secondary outcomes (11)
Duration of antibiotic therapy
Number of patients discontinuing treatment in both groups and what day they discontinue recorded
Measured: Day 14
Doses taken
Number of doses of antibiotic taken
Measured: Day 14
Duration of severe symptoms
Number of days until the last day the patient scores 5 in any of the symptoms in the RTI diary symptom
Measured: Day 14
Duration of moderate symptoms
Number of days until the last day the patient scores 3 in any of the symptoms in the RTI symptom diary.
Measured: Day 14
Total resolution of symptoms
Number of days until the last day the patient scores 0 in any of the symptoms in the RTI symptom diary.
Measured: Day 14
Re-attendance rate
Number of re-attendances to any doctor for new or worsening symptoms regarding the RTI regarding the infection
Measured: Day 28
Complication rate
Number of complications related to the infection, such as visits to emergency departments and/or hospital admissions regarding the RTI
Measured: Day 28
Absenteeism
Number of days of work absenteeism due to the infectious disease
Measured: Day 14
Adverse events
Drug-associated adverse events related to the antibiotic and antibiotics changed
Measured: Day 14
Use of other medication
Number of participants using antibiotics others than the study medication and other symptomatic therapies within the first two weeks
Measured: Day 14
Health quality of life
Variation of the score of the health-related quality of life on days 14 and 28, compared to baseline, measured using the EuroQol instrument, including visual analogical scale, ranging from 0 (worst health condition) to 100 (best health condition)
Measured: Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2024
- Study start1 Oct 2025 (estimated)
- Primary completion30 Mar 2027 (estimated)
- Study completion30 Apr 2027 (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 Acute Respiratory Tract InfectionStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients with acute RTIs will be randomized to either usual care (full-course antibiotic therapy based on current guidelines), or a tailored approach (patients will be advised to visit the center as soon as they feel better and are afebrile for a clinical assessment and C-reactive protein rapid testing after completing two full days of antibiotic).
- Masking
- None (open label)
- Enrolment
- 474 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rosa Morros, PhD, Study chair, University Institute in Primary Care Research Jordi Gol, Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06581367
- Sponsor's protocol ID
- IJG-STORM-2024
- Acronym
- STORM
- Status last verified
- Aug 2024
- First submitted
- 28 Aug 2024
- Last updated
- 3 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Sharing of the individual participating data, study protocol and statistical analysis plan.
Publications
Llor C, Frimodt-Moller N, Miravitlles M, Kahlmeter G, Bjerrum L. Optimising antibiotic exposure by customising the duration of treatment for respiratory tract infections based on patient needs in primary care. EClinicalMedicine. 2024 Jul 3;74:102723. doi: 10.1016/j.eclinm.2024.102723. eCollection 2024 Aug.
PubMed 39070175Morros R, Moragas A, Garcia-Sangenis A, Monfa R, Miravitlles M, Vallejo-Torres L, Jarca CI, Llor C. Tailoring Antibiotic Duration for Respiratory Tract Infections in Primary Care: Protocol for a Pragmatic Randomized Controlled Trial Study (STORM). JMIR Res Protoc. 2025 Oct 20;14:e75453. doi: 10.2196/75453.
PubMed 41115271
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tailoring Antibiotic Duration for Respiratory Tract Infections in Primary Care: a Pragmatic Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06581367
- Acronym / sponsor ID
- STORM / IJG-STORM-2024
- Conditions
- Acute Respiratory Tract Infection
- Keywords
- Antibacterial Agents Antimicrobial Resistance, Duration, Primary Health Care, Personalized Medicine, Drugs, Customized, Drug Resistance, Microbial, Patient-Centered Care
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 474 participants (estimated)
- Lead sponsor
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i GurinaUniversity, hospital or other
- Study start
- 1 Oct 2025 (estimated)
- Primary completion
- 30 Mar 2027 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 3 Sep 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.
The rise of drug-resistant organisms and the need to minimize side effects calls for a new approach to antibiotic therapy duration. This study explores tailoring the length of antibiotic treatment to patient recovery, focusing on whether adjusting therapy based on when the patient feels better is as effective as completing the prescribed course for acute respiratory tract infections (RTIs). The investigators will enroll 474 outpatients aged 18-75 with acute RTIs across 25 Spanish healthcare centers. Patients will be randomized into two groups: one following standard full-course antibiotic therapy, and another receiving a tailored approach, where treatment may be shortened based on clinical assessments. The primary outcome is clinical efficacy at day 14. Secondary outcomes include antibiotic duration, complications, and quality of life.
Detailed description
Background. Combating the rise of drug-resistant organisms and minimizing the side effects demand a shift in how we approach antibiotic therapy duration. A study focused on tailoring antibiotic length of therapy to patients\' needs as soon as they feel better, is a promising strategy. The investigators aim to assess whether adjusting the duration of antibiotic therapy according to individual patient needs, shortening it to the time when the patient feels better, proves as effective as completing the antibiotic course in acute respiratory tract infections (RTIs).
Methods. The investigators plan to enroll a minimum of 474 outpatients ranging from 18 to 75 years of age with clinical features of acute RTIs across 25 Spanish primary healthcare centers. Patients diagnosed with acute lower RTIs or acute rhinosinusitis, deemed by clinicians to require a beta-lactam course, will be randomized to either usual care, involving a full-course antibiotic therapy based on current guidelines, or a tailored approach. In the intervention group, patients will be advised to visit the center as soon as they feel better and are afebrile for a clinical assessment and C-reactive protein rapid testing after completing two full days of antibiotic. Treatment will be discontinued if these clinical results are normal. The primary outcome will be overall clinical efficacy at day 14, while secondary outcomes include duration, doses of antibiotic taken, complications and reattendance within the first month, drug-related adverse events, antibiotic given, other therapies, days of severe and moderate symptoms, days of symptoms, absenteeism and health-related quality of life. All participants will be given a symptom diary, recording their symptoms each evening. Additionally, a cost-effectiveness study and qualitative studies involving clinicians and patients aimed at exploring the strategy\'s pros, cons, uptake, and satisfaction levels will be carried out.
Discussion. The investigators will examine whether adults who present with symptoms of acute lower RTI or rhinosinusitis in general practice, who are treated with antibiotic courses until they feel better are as effective as longer standard courses. It is highly important that a possible reduction in the antibiotic course as soon as the patient feels better does not compromise patients' recovery or clinical course, which we will assess closely. This comprehensive approach aims to shed light on the practicality and impact of tailoring antibiotic duration in RTIs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients with acute RTIs will be randomized to either usual care (full-course antibiotic therapy based on current guidelines), or a tailored approach (patients will be advised to visit the center as soon as they feel better and are afebrile for a clinical assessment and C-reactive protein rapid testing after completing two full days of antibiotic).
| Arm | Type | Receives |
|---|---|---|
| Control group | Placebo comparator | Drug: Complete a 7-day courseFull-course antibiotic therapy based on current guidelines (7 days). |
| Intervention group | Active comparator | Drug: Tailoring the course duration to the patient's needs.In the intervention group, patients will be advised to visit the center as soon as they feel better and are afebrile for a clinical assessment and C-reactive protein rapid testing after completing two full days of antibiotic. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Either adults with a) acute cough (new cough or worsening of a previous cough) as the predominant symptom which the clinician believes to be a bacterial acute lower RTI, such as community-acquired pneumonia, acute bronchitis or acute chronic obstructive pulmonary disease (COPD) exacerbations, or b) an acute bacterial rhinosinusitis
- Doctors deem beta-lactam therapy (given every eight hours for a minimum of seven days) is necessary
Key exclusion criteria (16 listed)
- RTIs different from a lower RTI or acute rhinosinusitis
- Patients with suspected septicemia (quick Quick Sequential Organ Failure Assessment: respiratory rate ≥22 breaths/minute, systolic blood pressure <100 mm Hg or altered mental status with a Glasgow score < 5) ≥2
- Patients with pneumonia and [Confusion, respiratory rate ≥30 breaths/minute, blood pressure < 90/60 mm Hg, or age >65 yr.] ≥1
- Patients with very severe COPD (Forced Expiratory Volume in One Second <30%)
- Patients with COPD who have taken four or more antibiotic courses in the previous year, presence of significant bronchiectasis, and/or isolation of Pseudomonas in a previous sputum culture
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 |
|---|---|---|
| Tailoring the course duration to the patient's needs.Also: Patient-centered approachPatients will be advised to visit the center as soon as they feel better and are afebrile for a clinical assessment including vital signs (temperature, blood pressure, respiratory rate, pulse, and oxygen saturation) and C-reactive protein rapid testing after completing two full days of antibiotic. | Drug | Intervention group |
| Complete a 7-day courseAlso: Completion of the antibiotic courseThe antibiotic course must be completed (7 days at least). | Drug | Control group |
Primary outcome
Clinical resolution
Time frame: Day 14
Number of patients with disappearance of fever, disappearance or improvement in overall condition (all scores <2), such that no additional antimicrobial treatment is necessary.
11 secondary outcomes
Duration of antibiotic therapy
Time frame: Day 14
Doses taken
Time frame: Day 14
Duration of severe symptoms
Time frame: Day 14
Duration of moderate symptoms
Time frame: Day 14
Total resolution of symptoms
Time frame: Day 14
Re-attendance rate
Time frame: Day 28
Complication rate
Time frame: Day 28
Absenteeism
Time frame: Day 14
Adverse events
Time frame: Day 14
Use of other medication
Time frame: Day 14
Health quality of life
Time frame: Day 28
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 Sep 2024.
- Background: PubMed 39070175Llor C, Frimodt-Moller N, Miravitlles M, Kahlmeter G, Bjerrum L. Optimising antibiotic exposure by customising the duration of treatment for respiratory tract infections based on patient needs in primary care. EClinicalMedicine. 2024 Jul 3;74:102723. doi: 10.1016/j.eclinm.2024.102723. eCollection 2024 Aug.
- Derived from this study: PubMed 41115271Morros R, Moragas A, Garcia-Sangenis A, Monfa R, Miravitlles M, Vallejo-Torres L, Jarca CI, Llor C. Tailoring Antibiotic Duration for Respiratory Tract Infections in Primary Care: Protocol for a Pragmatic Randomized Controlled Trial Study (STORM). JMIR Res Protoc. 2025 Oct 20;14:e75453. doi: 10.2196/75453.
- Individual participant dataSharing planned: Yes. Sharing of the individual participating data, study protocol and statistical analysis plan.
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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.
Rosa Morros, PhD study chair
University Institute in Primary Care Research Jordi Gol, Barcelona
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tailoring the course duration to the patient's needs. and Complete a 7-day course in people with Acute Respiratory Tract Infection, run by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina.
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 2 inclusion and 16 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: opening soon, as of the sponsor's last update on 3 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Ramon Monfà, MSc (0034685409860, rmonfa@idiapjgol.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical resolution (time frame: Day 14). 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 NCT06581367, 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 3 Sep 2024.