A Phase 4 interventional study of Intervention and Control in Community-acquired Pneumonia, sponsored by Thomas Benfield. Completed at 7 sites in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-04-03.
Sponsored by Thomas Benfield · Phase 4, Interventional, and Treatment
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%.
2,044 studies on the registry are indexed under Pneumonia; 283 are open to participants now.
This study's enrollment of 395 is above the median of 106 across 1,247 interventional studies indexed under Pneumonia.
Browse Pneumonia studies →Thomas Benfield is the lead sponsor of 7 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Shortened antibiotic treatment of 5 days
Other: Intervention
Antibiotic treatment of 7 days or longer at the discretion of the treating physician
Other: Control
Shortened antibiotic treatment of 5 days
Antibiotic treatment of 7 days or longer at the discretion of the treating physician
90-day survival
Time frame: within 90 days
Duration of antibiotic treatment
Days that the participant receives antibiotic treatment for pneumonia, adding intravenous and oral therapy
Time frame: within 90 days
Length of hospital stay
Days from the date of hospital admission for pneumonia to the date of discharge
Time frame: within 90 days
Antibiotic adverse events
Number of participants with adverse events with possible relation to the antibiotic treatment of pneumonia
Time frame: 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
Time frame: 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
Time frame: within 90 days
Use of antimicrobials after discharge
Days of antibiotic treatment for any reason after hospital discharge
Time frame: 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
Time frame: within 90 days
Readmissions
Number of participants with readmissions for reasons related to or unrelated to pneumonia
Time frame: days 30 and 90
Mortality
Number of deaths by any cause
Time frame: in-hospital, days 30 and 90
Documents are hosted by the registry — open the source record to download them.
Plan to share: No — 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.
This study is completed, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.
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Thomas Benfield