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

NCT ID: NCT06295120

Last Updated: 2025-08-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-13

Study Completion Date

2026-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Community-acquired Pneumonia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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3 days

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

Group Type EXPERIMENTAL

Phenoxymethylpenicillin 1.2 MIE 4 times daily

Intervention Type 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.

4 days

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

Group Type EXPERIMENTAL

Phenoxymethylpenicillin 1.2 MIE 4 times daily

Intervention Type 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.

5 days

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

Group Type EXPERIMENTAL

Phenoxymethylpenicillin 1.2 MIE 4 times daily

Intervention Type 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.

6 days

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

Group Type EXPERIMENTAL

Phenoxymethylpenicillin 1.2 MIE 4 times daily

Intervention Type 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.

7 days

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

Group Type ACTIVE_COMPARATOR

Phenoxymethylpenicillin 1.2 MIE 4 times daily

Intervention Type 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.

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Research Unit for General Practice in Aalborg

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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The Research Unit for General Practice Aalborg

Gistrup, , Denmark

Site Status RECRUITING

Countries

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Denmark

Central Contacts

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Eskild Johansen, MD, Ph.d.-student

Role: CONTACT

+45 31 58 29 13

Malene Plejdrup Hansen, MD, Associate Professor

Role: CONTACT

Facility Contacts

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Line Maj Jensen

Role: primary

+45 25 69 99 33

References

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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.

Reference Type DERIVED
PMID: 39334468 (View on PubMed)

Other Identifiers

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362-1

Identifier Type: -

Identifier Source: org_study_id

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