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

Community-acquired Pneumonia Clinical Trial

— CAP-D  

Official title:

The Optimal Antibiotic Treatment Duration for Community-acquired Pneumonia in Adults Diagnosed in General Practice in Denmark: an Open-Label, Pragmatic, Randomised Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06295120
• Other study ID #: 362-1
• Status: Recruiting
• Phase: Phase 4
• 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
• 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.

Related Conditions & MeSH terms

• Community-acquired Pneumonia
• Pneumonia

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