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Recruiting NCT06295120

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

Phase IV Interventional Community-acquired Pneumonia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Phenoxymethylpenicillin 1.2 MIE 4 times daily.
Who it may be relevant to
Registry conditions: Community-acquired Pneumonia. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Denmark
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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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

Overview

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.

Interventions

  • Drug Phenoxymethylpenicillin 1.2 MIE 4 times daily
    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.

Primary outcome measures

  • Treatment failure at day 30 [Time frame: From randomisation to day 30]
Secondary outcome measures (11)
  • 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]

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

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Denmark · 1 center
  • The Research Unit for General Practice Aalborg — Gistrup

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. PMID 39334468

Identifiers

NCT: NCT06295120 · 362-1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗