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NCT Number: NCT06295120

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

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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Key information

Conditions

Community-Acquired Pneumonia Community-Acquired Infections Infections Pneumonia Respiratory Tract Diseases Respiratory Tract Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

The Research Unit for General Practice Aalborg

Gistrup, 9260, Denmark

Location status: Recruiting

Location contact

Line Maj Jensen

CONTACT

[email protected]

+45 25 69 99 33

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Clinical recovery at day 8

    Time frame: From randomisation to 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.

  2. The Acute Respiratory Tract Infection Questionnaire (ARTIQ) score

    Time frame: At randomisation day and day 8

    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).

  3. Prolonged antibiotic treatment

    Time frame: From randomisation to day 30

    Proportion of participants in need of prolonged antibiotic treatment.

  4. Change in type of antibiotic

    Time frame: From randomisation to day 30

    Proportion of participants who had prescribed another type of antibiotic treatment

  5. Relapse of acute Lower Respiratory Tract Infection (LRTI)

    Time frame: From randomisation to day 30

    Proportion of participants with relapse of acute LRTI

  6. Reconsultation

    Time frame: From randomisation to day 30

    Number of reconsultations at general practice or out-off-hour services

  7. New prescriptions within 30 days

    Time frame: From randomisation to day 30

    Proportion of participants with new prescriptions of symptomatic treatment (e.g. prednisolone, bronchodilator etc) within 30 days

  8. Hospitalisation

    Time frame: From randomisation to day 30

    Proportion of participants hospitalised within 30 days

  9. Mortality

    Time frame: From randomisation to day 30

    All-cause mortality at day 30

  10. Adverse events

    Time frame: From randomisation to day 30

    Proportion of participants experiencing adverse or serious adverse events

  11. Treatment adherence

    Time frame: From randomisation to day 8

    Initiation, implementation and discontinuation of the allocated treatment

Study contacts

Contact information is provided by the study sponsor or research team.

Eskild Johansen, MD, Ph.d.-student

CONTACT

[email protected]

+45 31 58 29 13

Malene Plejdrup Hansen, MD, Associate Professor

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Research Unit for General Practice in Aalborg

Other

Registry information

Official study 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

Acronym: CAP-D

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Mar 6, 2024
Registry last updated
Aug 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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