Shortened Antibiotic Treatment of 5 Days in Community-Acquired Pneumonia (CAP5)

April 2, 2025 updated by: Thomas Benfield

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%.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

395

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aalborg, Denmark, 9000
        • Aalborg University Hospital
      • Copenhagen, Denmark, 2400
        • Bispebjerg Hospital
      • Gentofte, Denmark, 2900
        • Gentofte Hospital
      • Herlev, Denmark, 2730
        • Herlev Hospital
      • Hillerød, Denmark, 3400
        • Nordsjællands Hospital
      • Hvidovre, Denmark, 2650
        • Hvidovre Hospital
      • Odense, Denmark, 5000
        • Odense University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
90-day survival
Time Frame: within 90 days
within 90 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of antibiotic treatment
Time Frame: within 90 days
Days that the participant receives antibiotic treatment for pneumonia, adding intravenous and oral therapy
within 90 days
Length of hospital stay
Time Frame: within 90 days
Days from the date of hospital admission for pneumonia to the date of discharge
within 90 days
Antibiotic adverse events
Time Frame: within 90 days
Number of participants with adverse events with possible relation to the antibiotic treatment of pneumonia
within 90 days
Serious adverse events
Time Frame: within 90 days
Number of participants with serious adverse events according to International Council of Harmonisation-Good Clinical Practice (ICH-GCP) guidelines
within 90 days
Major complications
Time Frame: within 90 days
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
Time Frame: within 90 days
Days of antibiotic treatment for any reason after hospital discharge
within 90 days
Post-discharge follow-up visits
Time Frame: within 90 days
Number of participants with medical visits after hospital discharge, including visits at the outpatient clinic and at the general practitioner
within 90 days
Readmissions
Time Frame: days 30 and 90
Number of participants with readmissions for reasons related to or unrelated to pneumonia
days 30 and 90
Mortality
Time Frame: in-hospital, days 30 and 90
Number of deaths by any cause
in-hospital, days 30 and 90

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Thomas Benfield

Investigators

  • Principal Investigator: Simone Bastrup Israelsen, MD, Copenhagen University Hospital - Amager and Hvidovre, Hvidovre, Denmark

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 18, 2019

Primary Completion (Actual)

January 22, 2025

Study Completion (Actual)

January 22, 2025

Study Registration Dates

First Submitted

September 11, 2019

First Submitted That Met QC Criteria

September 12, 2019

First Posted (Actual)

September 13, 2019

Study Record Updates

Last Update Posted (Actual)

April 3, 2025

Last Update Submitted That Met QC Criteria

April 2, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-19014479
  • 2019-000404-15 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Trial data will be made available in anonymous form at public clinical trial databases when the trial has ended. Anonymized patient-level data and other detailed information will be provided by reasonable request to the principal investigator.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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