The Optimal Antibiotic Treatment Duration for Community-acquired Pneumonia in Adults Diagnosed in General Practice in Denmark (CAP-D)

Research Unit for General Practice in Aalborg

Status and phase: Enrolling; Phase 4

Conditions: Community-acquired Pneumonia

Treatments: Drug: Phenoxymethylpenicillin 1.2 MIE 4 times daily

Study type: Interventional

Funder types: Other

Identifiers

NCT06295120

362-1

Details and patient eligibility

About

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.

Enrollment: 600 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

1. Need for immediate hospitalisation at the time of diagnosis.
2. Known allergy to beta-lactam antibiotics.
3. Any coinfection necessitating antibiotic treatment.
4. Use of systemic antibiotics or antivirals within the last month.
5. Pre-existing lung disease (e.g., chronic obstructive pulmonary disease, bronchiectasis, asthma, lung cancer).
6. Known immunosuppression (i.e., long term treatment with corticosteroid, chemotherapy, or immune disorder).
7. Pregnant or lactating.
8. Patients not capable of consenting and/or patients deemed non-suitable for participation by the healthcare professional.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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600 participants in 5 patient groups

3 days

Experimental group

Description:

3 days of treatment with phenoxymethylpenicillin 1.2 MIE 4 times daily.

Treatment:

Drug: Phenoxymethylpenicillin 1.2 MIE 4 times daily

4 days

Experimental group

Description:

4 days of treatment with phenoxymethylpenicillin 1.2 MIE 4 times daily.

Treatment:

Drug: Phenoxymethylpenicillin 1.2 MIE 4 times daily

5 days

Experimental group

Description:

5 days of treatment with phenoxymethylpenicillin 1.2 MIE 4 times daily.

Treatment:

Drug: Phenoxymethylpenicillin 1.2 MIE 4 times daily

6 days

Experimental group

Description:

6 days of treatment with phenoxymethylpenicillin 1.2 MIE 4 times daily.

Treatment:

Drug: Phenoxymethylpenicillin 1.2 MIE 4 times daily

7 days

Active Comparator group

Description:

7 days of treatment with phenoxymethylpenicillin 1.2 MIE 4 times daily.

Treatment:

Drug: Phenoxymethylpenicillin 1.2 MIE 4 times daily