Community-acquired PneumoniaPhase 4CAP-DNCT06295120
The Optimal Antibiotic Treatment Duration for Community-acquired Pneumonia in Adults Diagnosed in General Practice in Denmark (CAP-D)
A Phase 4 study testing Phenoxymethylpenicillin 1.2 MIE 4 times daily in people with Community-acquired Pneumonia, run by Research Unit for General Practice in Aalborg at 1 site in Denmark.
Trial summary
The aim of this randomised controlled trial is to identify the optimal treatment duration with phenoxymethylpenicillin for community-acquired pneumonia diagnosed in general practice. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Community-acquired Pneumonia
- What is being tested?
- Phenoxymethylpenicillin 1.2 MIE 4 times daily
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 307 participants
- Where
- 1 siteDenmark
- Study dates
- 13 Nov 2023to 31 Mar 2026
- Phase
- Phase 4
- 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
- Eligible participants are adults (≥18 years) presenting in general practice with symptoms of an acute LRTI (i.e., acute illness (≤ 21 days) usually with cough and minimum one other symptom such as dyspnoea, sputum production, wheezing, chest discomfort or fever) in whom the GP finds it relevant to treat with antibiotics.
Who cannot join
- Need for immediate hospitalisation at the time of diagnosis.
- Known allergy to beta-lactam antibiotics.
- Any coinfection necessitating antibiotic treatment.
- Use of systemic antibiotics or antivirals within the last month.
- Pre-existing lung disease (e.g., chronic obstructive pulmonary disease, bronchiectasis, asthma, lung cancer).
- Known immunosuppression (i.e., long term treatment with corticosteroid, chemotherapy, or immune disorder).
- Pregnant or lactating.
- Patients not capable of consenting and/or patients deemed non-suitable for participation by the healthcare professional.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Optimal Antibiotic Treatment Duration for Community-acquired Pneumonia in Adults Diagnosed in General Practice in Denmark: an Open-Label, Pragmatic, Randomised Controlled Trial
The aim of this randomised controlled trial is to identify the optimal treatment duration with phenoxymethylpenicillin for community-acquired pneumonia diagnosed in general practice.
Eligible participants are adults (≥18 years) presenting in general practice with symptoms of an acute LRTI (i.e., acute illness (≤ 21 days) usually with cough and minimum one other symptom such as dyspnea, sputum production, wheezing, chest discomfort or fever) in whom the GP finds it relevant to treat with antibiotics.
Consenting patients who meet all the eligibility criteria will be randomised (1:1:1:1:1) to either three, four, five, six or seven days of treatment with phenoxymethylpenicillin 1.2 MIE four times daily.
- Conditions
- Community-acquired Pneumonia
- Being tested
- Phenoxymethylpenicillin 1.2 MIE 4 times daily
- Keywords
- Community-acquired pneumonia, Treatment duration, Phenoxymethylpenicillin, General Practice
- Medical subject headings
- Community-Acquired Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phenoxymethylpenicillin 1.2 MIE 4 times dailyDrug
The intervention is the duration of treatment with phenoxymethylpenicillin from 3 to 7 days. Dose and frequency of the treatment is the same in the different arms.
| Study group | Role | What they receive |
|---|---|---|
| 3 days | Experimental | 3 days of treatment with phenoxymethylpenicillin 1.2 MIE 4 times daily. Receives: Drug: Phenoxymethylpenicillin 1.2 MIE 4 times daily |
| 4 days | Experimental | 4 days of treatment with phenoxymethylpenicillin 1.2 MIE 4 times daily. Receives: Drug: Phenoxymethylpenicillin 1.2 MIE 4 times daily |
| 5 days | Experimental | 5 days of treatment with phenoxymethylpenicillin 1.2 MIE 4 times daily. Receives: Drug: Phenoxymethylpenicillin 1.2 MIE 4 times daily |
| 6 days | Experimental | 6 days of treatment with phenoxymethylpenicillin 1.2 MIE 4 times daily. Receives: Drug: Phenoxymethylpenicillin 1.2 MIE 4 times daily |
| 7 days | Active comparator | 7 days of treatment with phenoxymethylpenicillin 1.2 MIE 4 times daily. Receives: Drug: Phenoxymethylpenicillin 1.2 MIE 4 times daily |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment failure at day 30
Treatment failure is defined as any hospitalisation OR change in the antibiotic strategy (i.e., prolongation of the duration, change in antibiotic type, new antibiotic prescription) due to symptoms of acute respiratory tract infection - between randomisation and day 30.
Measured: From randomisation to day 30
Secondary outcomes (11)
Clinical recovery at day 8
Clinical recovery is defined as: The participant scores below a pre-defined cut-off point for being recovered at the Acute Respiratory Tract Infection Questionnaire OR reports feeling recovered by themselves AND the participant is no longer treated with any antibiotics.
Measured: From randomisation to day 8
The Acute Respiratory Tract Infection Questionnaire (ARTIQ) score
The Acute Respiratory Tract Infection Questionnaire is a validated, self-administered, multidimensional, sum-scaling symptom score monitoring the severity and functional impact of acute respiratory tract infections in general practice. The questionnaire consists of five single items and 37 items covering five independent dimensions: upper respiratory tract symptoms, lower respiratory tract symptoms, physiological, sleep, and medicine. The participants will be asked to evaluate each item, over the past 24 hours by using a three-point scale: "No (0 point)", "Yes - some (1 point)" or "Yes - a lot (2 points)". Ten items are dichotomized: "Yes (1 point) or "No (0 point)"). The total ARTIQ score is calculated as the sum of each dimension and single items (minimum 0 - maximum 74).
Measured: At randomisation day and day 8
Prolonged antibiotic treatment
Proportion of participants in need of prolonged antibiotic treatment.
Measured: From randomisation to day 30
Change in type of antibiotic
Proportion of participants who had prescribed another type of antibiotic treatment
Measured: From randomisation to day 30
Relapse of acute Lower Respiratory Tract Infection (LRTI)
Proportion of participants with relapse of acute LRTI
Measured: From randomisation to day 30
Reconsultation
Number of reconsultations at general practice or out-off-hour services
Measured: From randomisation to day 30
New prescriptions within 30 days
Proportion of participants with new prescriptions of symptomatic treatment (e.g. prednisolone, bronchodilator etc) within 30 days
Measured: From randomisation to day 30
Hospitalisation
Proportion of participants hospitalised within 30 days
Measured: From randomisation to day 30
Mortality
All-cause mortality at day 30
Measured: From randomisation to day 30
Adverse events
Proportion of participants experiencing adverse or serious adverse events
Measured: From randomisation to day 30
Treatment adherence
Initiation, implementation and discontinuation of the allocated treatment
Measured: From randomisation to day 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2024
- Study start13 Nov 2023
- Primary completion31 Mar 2026
- Study completion31 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Community-acquired PneumoniaStudies 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
- Masking
- None (open label)
- Enrolment
- 307 participants (actual)
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
- NCT06295120
- Sponsor's protocol ID
- 362-1
- Acronym
- CAP-D
- Status last verified
- Jan 2026
- First submitted
- 28 Feb 2024
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Johansen E, Nielsen H, Gillespie D, Aabenhus R, Hansen MP. The optimal antibiotic treatment duration for community-acquired pneumonia in adults diagnosed in general practice in Denmark (CAP-D): an open-label, pragmatic, randomised controlled trial. Trials. 2024 Sep 27;25(1):627. doi: 10.1186/s13063-024-08477-z.
PubMed 39334468
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Optimal Antibiotic Treatment Duration for Community-acquired Pneumonia in Adults Diagnosed in General Practice in Denmark: an Open-Label, Pragmatic, Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT06295120
- Acronym / sponsor ID
- CAP-D / 362-1
- Conditions
- Community-acquired Pneumonia
- Keywords
- Community-acquired pneumonia, Treatment duration, Phenoxymethylpenicillin, General Practice
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 307 participants (actual)
- Lead sponsor
- Research Unit for General Practice in AalborgUniversity, hospital or other
- Study start
- 13 Nov 2023 (actual)
- Primary completion
- 31 Mar 2026 (actual)
- Study completion
- 31 Mar 2026 (actual)
- First posted
- 6 Mar 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 aim of this randomised controlled trial is to identify the optimal treatment duration with phenoxymethylpenicillin for community-acquired pneumonia diagnosed in general practice.
Eligible participants are adults (≥18 years) presenting in general practice with symptoms of an acute LRTI (i.e., acute illness (≤ 21 days) usually with cough and minimum one other symptom such as dyspnea, sputum production, wheezing, chest discomfort or fever) in whom the GP finds it relevant to treat with antibiotics.
Consenting patients who meet all the eligibility criteria will be randomised (1:1:1:1:1) to either three, four, five, six or seven days of treatment with phenoxymethylpenicillin 1.2 MIE four times daily.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 3 days | Experimental | Drug: Phenoxymethylpenicillin 1.2 MIE 4 times daily3 days of treatment with phenoxymethylpenicillin 1.2 MIE 4 times daily. |
| 4 days | Experimental | Drug: Phenoxymethylpenicillin 1.2 MIE 4 times daily4 days of treatment with phenoxymethylpenicillin 1.2 MIE 4 times daily. |
| 5 days | Experimental | Drug: Phenoxymethylpenicillin 1.2 MIE 4 times daily5 days of treatment with phenoxymethylpenicillin 1.2 MIE 4 times daily. |
| 6 days | Experimental | Drug: Phenoxymethylpenicillin 1.2 MIE 4 times daily6 days of treatment with phenoxymethylpenicillin 1.2 MIE 4 times daily. |
| 7 days | Active comparator | Drug: Phenoxymethylpenicillin 1.2 MIE 4 times daily7 days of treatment with phenoxymethylpenicillin 1.2 MIE 4 times daily. |
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 participants are adults (≥18 years) presenting in general practice with symptoms of an acute LRTI (i.e., acute illness (≤ 21 days) usually with cough and minimum one other symptom such as dyspnoea, sputum production, wheezing, chest discomfort or fever) in whom the GP finds it relevant to treat with antibiotics.
Key exclusion criteria (8 listed)
- Need for immediate hospitalisation at the time of diagnosis.
- Known allergy to beta-lactam antibiotics.
- Any coinfection necessitating antibiotic treatment.
- Use of systemic antibiotics or antivirals within the last month.
- Pre-existing lung disease (e.g., chronic obstructive pulmonary disease, bronchiectasis, asthma, lung cancer).
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 |
|---|---|---|
| Phenoxymethylpenicillin 1.2 MIE 4 times dailyThe intervention is the duration of treatment with phenoxymethylpenicillin from 3 to 7 days. Dose and frequency of the treatment is the same in the different arms. | Drug | 3 days, 4 days, 5 days, 6 days, 7 days |
Primary outcome
Treatment failure at day 30
Time frame: From randomisation to day 30
Treatment failure is defined as any hospitalisation OR change in the antibiotic strategy (i.e., prolongation of the duration, change in antibiotic type, new antibiotic prescription) due to symptoms of acute respiratory tract infection - between randomisation and day 30.
11 secondary outcomes
Clinical recovery at day 8
Time frame: From randomisation to day 8
The Acute Respiratory Tract Infection Questionnaire (ARTIQ) score
Time frame: At randomisation day and day 8
Prolonged antibiotic treatment
Time frame: From randomisation to day 30
Change in type of antibiotic
Time frame: From randomisation to day 30
Relapse of acute Lower Respiratory Tract Infection (LRTI)
Time frame: From randomisation to day 30
Reconsultation
Time frame: From randomisation to day 30
New prescriptions within 30 days
Time frame: From randomisation to day 30
Hospitalisation
Time frame: From randomisation to day 30
Mortality
Time frame: From randomisation to day 30
Adverse events
Time frame: From randomisation to day 30
Treatment adherence
Time frame: From randomisation to day 8
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 22 Oct 2026.
- Derived from this study: PubMed 39334468Johansen E, Nielsen H, Gillespie D, Aabenhus R, Hansen MP. The optimal antibiotic treatment duration for community-acquired pneumonia in adults diagnosed in general practice in Denmark (CAP-D): an open-label, pragmatic, randomised controlled trial. Trials. 2024 Sep 27;25(1):627. doi: 10.1186/s13063-024-08477-z.
- Study protocolLink provided by the sponsor.
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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.
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 Phase 4 study testing Phenoxymethylpenicillin 1.2 MIE 4 times daily in people with Community-acquired Pneumonia, 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 8 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 22 Oct 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.
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?
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?
Treatment failure at day 30 (time frame: From randomisation to day 30). 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 NCT06295120, which also lists 1 linked publication.
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 22 Oct 2026.