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

NCT06295120 | Recruiting Phase 4

• 1 other identifier: 362-1
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

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.

Conditions

Community-acquired Pneumonia

Keywords

Community-acquired pneumonia; Treatment duration; Phenoxymethylpenicillin; General Practice

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• Clinical recovery at day 8

  From randomisation to day 8

• The Acute Respiratory Tract Infection Questionnaire (ARTIQ) score

  At randomisation day and day 8

• Prolonged antibiotic treatment

  From randomisation to day 30

• Change in type of antibiotic

  From randomisation to day 30

• Relapse of acute Lower Respiratory Tract Infection (LRTI)

  From randomisation to day 30

Study Arms (5)

3 days

EXPERIMENTAL

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

Drug: Phenoxymethylpenicillin 1.2 MIE 4 times daily

4 days

EXPERIMENTAL

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

Drug: Phenoxymethylpenicillin 1.2 MIE 4 times daily

5 days

EXPERIMENTAL

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

Drug: Phenoxymethylpenicillin 1.2 MIE 4 times daily

6 days

EXPERIMENTAL

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

Drug: Phenoxymethylpenicillin 1.2 MIE 4 times daily

7 days

ACTIVE COMPARATOR

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

Drug: Phenoxymethylpenicillin 1.2 MIE 4 times daily

Interventions

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.

3 days; 4 days; 5 days; 6 days; 7 days

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Research Unit for General Practice in Aalborg: lead

Study Sites (1)

The Research Unit for General Practice Aalborg

Gistrup, 9260, Denmark

RECRUITING

Related Publications (1)

• 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 DERIVED

MeSH Terms

Conditions

Community-Acquired Pneumonia

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Eskild Johansen, MD, Ph.d.-student

CONTACT

+45 31 58 29 13; ejoha@dcm.aau.dk

Malene Plejdrup Hansen, MD, Associate Professor

CONTACT

mph@dcm.aau.dk

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2024
• First Posted: March 6, 2024
• Study Start: November 13, 2023
• Primary Completion: March 31, 2026
• Study Completion: March 31, 2026
• Last Updated: August 17, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)