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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 3 days | Experimental | 3 days of treatment with phenoxymethylpenicillin 1.2 MIE 4 times daily. |
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| 4 days | Experimental | 4 days of treatment with phenoxymethylpenicillin 1.2 MIE 4 times daily. |
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| 5 days | Experimental | 5 days of treatment with phenoxymethylpenicillin 1.2 MIE 4 times daily. |
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| 6 days | Experimental | 6 days of treatment with phenoxymethylpenicillin 1.2 MIE 4 times daily. |
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| 7 days | Active Comparator | 7 days of treatment with phenoxymethylpenicillin 1.2 MIE 4 times daily. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Phenoxymethylpenicillin 1.2 MIE 4 times daily | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From randomisation to day 30 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From randomisation to day 8 |
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Inclusion Criteria:
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.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Eskild Johansen, MD, Ph.d.-student | Contact | +45 31 58 29 13 | ejoha@dcm.aau.dk | |
| Malene Plejdrup Hansen, MD, Associate Professor | Contact | mph@dcm.aau.dk |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Research Unit for General Practice Aalborg | Recruiting | Gistrup | 9260 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39334468 | Derived | 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. |
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| 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). |
| At randomisation day and day 8 |
| Prolonged antibiotic treatment | Proportion of participants in need of prolonged antibiotic treatment. | From randomisation to day 30 |
| Change in type of antibiotic | Proportion of participants who had prescribed another type of antibiotic treatment | From randomisation to day 30 |
| Relapse of acute Lower Respiratory Tract Infection (LRTI) | Proportion of participants with relapse of acute LRTI | From randomisation to day 30 |
| Reconsultation | Number of reconsultations at general practice or out-off-hour services | 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 | From randomisation to day 30 |
| Hospitalisation | Proportion of participants hospitalised within 30 days | From randomisation to day 30 |
| Mortality | All-cause mortality at day 30 | From randomisation to day 30 |
| Adverse events | Proportion of participants experiencing adverse or serious adverse events | From randomisation to day 30 |
| Treatment adherence | Initiation, implementation and discontinuation of the allocated treatment | From randomisation to day 8 |
| ID | Term |
|---|---|
| D000098968 | Community-Acquired Pneumonia |
| ID | Term |
|---|---|
| D017714 | Community-Acquired Infections |
| D007239 | Infections |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D012140 | Respiratory Tract Diseases |
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