Clinical trial NCT06295120: The Optimal Antibiotic Treatment Duration for Community-acquired Pneumonia in Adults Diagnosed in General Practice in Denmark (CAP-D)
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Community-acquired Pneumonia
Keywords: Community-acquired pneumonia
Treatment duration
Phenoxymethylpenicillin
General Practice
Lead sponsor: Research Unit for General Practice in Aalborg
Sponsor class: OTHER
First posted: 2024-03-06
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Treatment failure at day 30
timeFrame: From randomisation to day 30
Secondary outcomes:
measure: Clinical recovery at day 8
timeFrame: From randomisation to day 8
measure: The Acute Respiratory Tract Infection Questionnaire (ARTIQ) score
timeFrame: At randomisation day and day 8
measure: Prolonged antibiotic treatment
timeFrame: From randomisation to day 30
measure: Change in type of antibiotic
timeFrame: From randomisation to day 30
measure: Relapse of acute Lower Respiratory Tract Infection (LRTI)
timeFrame: From randomisation to day 30
measure: Reconsultation
timeFrame: From randomisation to day 30
measure: New prescriptions within 30 days
timeFrame: From randomisation to day 30
measure: Hospitalisation
timeFrame: From randomisation to day 30
measure: Mortality
timeFrame: From randomisation to day 30
measure: Adverse events
timeFrame: From randomisation to day 30
measure: Treatment adherence
timeFrame: From randomisation to day 8
Other outcomes:
Locations:
city: Gistrup
country: Denmark
facility: The Research Unit for General Practice Aalborg
Study officials:
References: