NCT04089787

Shortened Antibiotic Treatment of 5 Days in Community-Acquired Pneumonia

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 395 (actual)
• Sponsor: Thomas Benfield · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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%.

Conditions

• Community-acquired Pneumonia

Interventions

Type	Name	Description
OTHER	Intervention	Shortened antibiotic treatment of 5 days
OTHER	Control	Antibiotic treatment of 7 days or longer at the discretion of the treating physician

Timeline

• Start date: 2019-09-18
• Primary completion: 2025-01-22
• Completion: 2025-01-22
• First posted: 2019-09-13
• Last updated: 2025-04-03

Locations

7 sites across 1 country: Denmark