Shortened Antibiotic Treatment of 5 Days in Community-Acquired Pneumonia

Study Overview
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Brief Summary
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CAP5 is an investigator-initiated multicentre non-inferiority randomized controlled trial which aims to assess the efficacy and safety of shortened antibiotic treatment duration of community-acquired pneumonia (CAP) in hospitalized adult patients based on clinical stability criteria. Five days after initiation of antimicrobial therapy for CAP, participants are randomized 1:1 to parallel treatment arms: 5 days (intervention) or minimum 7 days (control) of antibiotic treatment. The intervention group discontinues antibiotics at day 5 if clinically stable and afebrile for at least 48 hours. The control group receives antibiotics for a duration of 7 days or longer at the discretion of the treating physician. The primary outcome is 90-day readmission-free survival which will be tested with a non-inferiority margin of 6%.

Official Title
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Shortened Antibiotic Treatment in Community-Acquired Pneumonia: A Nationwide Danish Randomized Controlled Trial

Conditions
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Community-acquired Pneumonia

Intervention / Treatment
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* Other: Intervention
* Other: Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Hospitalized with community-acquired pneumonia; defined as new pulmonary infiltrate on chest X-ray and at least one symptom compatible with pneumonia (cough, fever, dyspnoea and/or chest pain) Initiation of antibiotics within 12 hours of the time of the chest X-ray with an infiltrate Age ≥ 18 years Afebrile (temperature ≤ 37.8 °C) for 48 hours at randomization Clinically stable at randomization (systolic blood pressure ≥ 90 mm Hg, heart rate ≤ 100/min., respiratory rate ≤ 24/min., peripheral oxygen saturation ≥ 90%) Exclusion Criteria: Immunosuppression (HIV-positive, neutropenia, corticosteroid treatment (≥10 mg/day of prednisone or the equivalent for >30 days), chemotherapy, immunosuppressive agents, immunosuppressed after solid organ transplantation, asplenia) Hospitalization during the previous 14 days Antibiotic treatment (>2 days) within the past 30 days Uncommon cause requiring longer duration of antimicrobial therapy (Pseudomonas aeruginosa, Staphylococcus aureus, Mycobacterium spp., fungi) Extrapulmonary infection (e.g. endocarditis, meningitis, or abscess) Pleural empyema or lung abscess Pleural effusion requiring drainage tube Intensive care unit (ICU) admittance Pregnancy and breastfeeding

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>Shortened antibiotic treatment of 5 days | Other: Intervention<br>* Shortened antibiotic treatment of 5 days<br>|
| Active Comparator: Control group<br>Antibiotic treatment of 7 days or longer at the discretion of the treating physician | Other: Control<br>* Antibiotic treatment of 7 days or longer at the discretion of the treating physician<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 90-day readmission-free survival |  | within 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of antibiotic treatment | Days that the participant receives antibiotic treatment for pneumonia, adding intravenous and oral therapy | within 90 days | 
| Length of hospital stay | Days from the date of hospital admission for pneumonia to the date of discharge | within 90 days | 
| Antibiotic adverse events | Number of participants with adverse events with possible relation to the antibiotic treatment of pneumonia | within 90 days | 
| Serious adverse events | Number of participants with serious adverse events according to International Council of Harmonisation-Good Clinical Practice (ICH-GCP) guidelines | within 90 days | 
| Major complications | Number of participants with major complications, including pleural effusion, pleural empyema, lung abscess, respiratory failure, severe sepsis, renal failure, use of non-invasive or invasive ventilation, need for vasopressors, and intensive care unit (ICU) admission | within 90 days | 
| Use of antimicrobials after discharge | Days of antibiotic treatment for any reason after hospital discharge | within 90 days | 
| Post-discharge follow-up visits | Number of participants with medical visits after hospital discharge, including visits at the outpatient clinic and at the general practitioner | within 90 days | 
| Readmissions | Number of participants with readmissions for reasons related to or unrelated to pneumonia | days 30 and 90 | 
| Mortality | Number of deaths by any cause | in-hospital, days 30 and 90 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Respiratory Tract Infections, Community-acquired pneumonia, Treatment duration, Pneumonia, Lung Diseases, Respiratory Tract Diseases, Bacterial Infections, Pneumonia, Bacterial, Anti-Infective Agents, Anti-Bacterial Agents