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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
600
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.
The Research Unit for General Practice Aalborg
Gistrup, Denmark
RECRUITINGTreatment 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
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
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
Prolonged antibiotic treatment
Proportion of participants in need of prolonged antibiotic treatment.
Time frame: From randomisation to day 30
Change in type of antibiotic
Proportion of participants who had prescribed another type of antibiotic treatment
Time frame: From randomisation to day 30
Relapse of acute Lower Respiratory Tract Infection (LRTI)
Proportion of participants with relapse of acute LRTI
Time frame: From randomisation to day 30
Reconsultation
Number of reconsultations at general practice or out-off-hour services
Time frame: 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
Time frame: From randomisation to day 30
Hospitalisation
Proportion of participants hospitalised within 30 days
Time frame: From randomisation to day 30
Mortality
All-cause mortality at day 30
Time frame: From randomisation to day 30
Adverse events
Proportion of participants experiencing adverse or serious adverse events
Time frame: From randomisation to day 30
Treatment adherence
Initiation, implementation and discontinuation of the allocated treatment
Time frame: From randomisation to day 8
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