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Shortened Antibiotic Treatment of 5 Days in Community-Acquired Pneumonia

NCT04089787 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 395

Last updated 2025-04-03

No results posted yet for this study

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

OTHER

Intervention

Shortened antibiotic treatment of 5 days

OTHER

Control

Antibiotic treatment of 7 days or longer at the discretion of the treating physician

Sponsors & Collaborators

  • Thomas Benfield

    lead OTHER

Principal Investigators

  • Simone Bastrup Israelsen, MD · Copenhagen University Hospital - Amager and Hvidovre, Hvidovre, Denmark

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-18
Primary Completion
2025-01-22
Completion
2025-01-22

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04089787 on ClinicalTrials.gov