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

The Optimal Antibiotic Treatment Duration for Community-acquired Pneumonia in Adults Diagnosed in General Practice in Denmark: an Open-Label, Pragmatic, Randomised Controlled Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Community-acquired Pneumonia
• Intervention / Treatment: Drug: Phenoxymethylpenicillin 1.2 MIE 4 times daily

• Study Type: Interventional
• Enrollment (Estimated): 600
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Eskild Johansen, MD, Ph.d.-student; Phone Number: +45 31 58 29 13; Email: ejoha@dcm.aau.dk
• Study Contact Backup: Name: Malene Plejdrup Hansen, MD, Associate Professor; Email: mph@dcm.aau.dk

Study Locations

• Denmark
  • Gistrup, Denmark, 9260
    • Recruiting
    • The Research Unit for General Practice Aalborg
    • Contact: Line Maj Jensen; Phone Number: +45 25 69 99 33; Email: lmj@dcm.aau.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 3 days; 3 days of treatment with phenoxymethylpenicillin 1.2 MIE 4 times daily.	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.
Experimental: 4 days; 4 days of treatment with phenoxymethylpenicillin 1.2 MIE 4 times daily.	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.
Experimental: 5 days; 5 days of treatment with phenoxymethylpenicillin 1.2 MIE 4 times daily.	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.
Experimental: 6 days; 6 days of treatment with phenoxymethylpenicillin 1.2 MIE 4 times daily.	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.
Active Comparator: 7 days; 7 days of treatment with phenoxymethylpenicillin 1.2 MIE 4 times daily.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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
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
Treatment adherence	Initiation, implementation and discontinuation of the allocated treatment	From randomisation to day 8
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
Adverse events	Proportion of participants experiencing adverse or serious adverse events	From randomisation to day 30

Collaborators and Investigators

• Sponsor: Research Unit for General Practice in Aalborg

Study record dates

Study Major Dates

• Study Start (Actual): November 13, 2023
• Primary Completion (Estimated): March 31, 2026
• Study Completion (Estimated): March 31, 2026

Study Registration Dates

• First Submitted: February 28, 2024
• First Submitted That Met QC Criteria: February 28, 2024
• First Posted (Actual): March 6, 2024

Study Record Updates

• Last Update Posted (Actual): August 17, 2025
• Last Update Submitted That Met QC Criteria: August 15, 2025
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: General Practice; Community-acquired pneumonia; Treatment duration; Phenoxymethylpenicillin
• Additional Relevant MeSH Terms: Respiratory Tract Infections; Infections; Respiratory Tract Diseases; Lung Diseases; Pneumonia; Anti-Bacterial Agents; Anti-Infective Agents; Penicillin V
• Other Study ID Numbers: 362-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No