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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06295120
Other study ID # 362-1
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
Start date November 13, 2023
Est. completion date December 31, 2024

Study information

Verified date March 2024
Source Research Unit for General Practice in Aalborg
Contact Eskild Johansen, MD, Ph.d.-student
Phone +45 31 58 29 13
Email ejoha@dcm.aau.dk
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 600
Est. completion date December 31, 2024
Est. primary completion date December 31, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Denmark The Research Unit for General Practice Aalborg Gistrup

Sponsors (1)

Lead Sponsor Collaborator
Research Unit for General Practice in Aalborg

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
Secondary 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
Secondary Prolonged antibiotic treatment Proportion of participants in need of prolonged antibiotic treatment. From randomisation to day 30
Secondary Change in type of antibiotic Proportion of participants who had prescribed another type of antibiotic treatment From randomisation to day 30
Secondary Relapse of acute Lower Respiratory Tract Infection (LRTI) Proportion of participants with relapse of acute LRTI From randomisation to day 30
Secondary Reconsultation Number of reconsultations at general practice or out-off-hour services From randomisation to day 30
Secondary 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
Secondary Hospitalisation Proportion of participants hospitalised within 30 days From randomisation to day 30
Secondary Mortality All-cause mortality at day 30 From randomisation to day 30
Secondary Adverse events Proportion of participants experiencing adverse or serious adverse events From randomisation to day 30
Secondary Treatment adherence Initiation, implementation and discontinuation of the allocated treatment From randomisation to day 8
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