Shortened Antibiotic Treatment of 5 Days in Community-Acquired Pneumonia

Phase 4

Completed

• Conditions: Community-acquired Pneumonia
• Interventions: Other: Intervention; Other: Control

• Registration Number: NCT04089787
• Lead Sponsor: Thomas Benfield

Brief 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.

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 readmission-free survival which will be tested with a non-inferiority margin of 6%.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-09-11
• Study First Submitted QC: 2019-09-12
• Study First Posted: 2019-09-13
• Study Start: 2019-09-18
• Primary Completion: 2025-01-22
• Study Completion: 2025-01-22
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-02
• Last Update Posted: 2025-04-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 395

Inclusion Criteria

• Hospitalized with community-acquired pneumonia; defined as new pulmonary infiltrate on chest X-ray 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
• 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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group	Intervention	Shortened antibiotic treatment of 5 days
Control group	Control	Antibiotic treatment of 7 days or longer at the discretion of the treating physician

Primary Outcome Measures

Name	Time	Method
90-day survival	within 90 days

Secondary Outcome Measures

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

Trial Locations

Locations (7)

Aalborg University Hospital; 🇩🇰 Aalborg, Denmark

Bispebjerg Hospital; 🇩🇰 Copenhagen, Denmark

Gentofte Hospital; 🇩🇰 Gentofte, Denmark

Herlev Hospital; 🇩🇰 Herlev, Denmark

Nordsjællands Hospital; 🇩🇰 Hillerød, Denmark

Hvidovre Hospital; 🇩🇰 Hvidovre, Denmark

Odense University Hospital; 🇩🇰 Odense, Denmark