Shortened Antibiotic Treatment of 5 Days in Community-Acquired Pneumonia

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

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.

Three to 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 survival which will be tested with a non-inferiority margin of 6%.

Inclusion Criteria:

• Hospitalized with community-acquired pneumonia; defined as new pulmonary infiltrate on chest X-ray and/or CT scan 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, directed at lower respiratory tract pathogens
• 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