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

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorResearch Unit for General Practice in Aalborg

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

600 Participants
are divided into 5 treatment groups
Group A: 3 daysExperimental treatment 1 intervention
Group B: 4 daysExperimental treatment 1 intervention
Group C: 5 daysExperimental treatment 1 intervention
Group D: 6 daysExperimental treatment 1 intervention
Group E: 7 daysActive comparator 1 intervention

Trial outcomes

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.

Time frame
From randomisation to day 30

Secondary outcomes

1

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.

Time frame
From randomisation to day 8
2

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).

Time frame
At randomisation day and day 8
3

Prolonged antibiotic treatment

Proportion of participants in need of prolonged antibiotic treatment.

Time frame
From randomisation to day 30
4

Change in type of antibiotic

Proportion of participants who had prescribed another type of antibiotic treatment

Time frame
From randomisation to day 30

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.