Shortened Antibiotic Treatment of 5 Days in Community-Acquired Pneumonia

NCT ID: NCT04089787

Last Updated: 2025-04-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 395 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-18
• Study Completion Date: 2025-01-22

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Intervention group

Shortened antibiotic treatment of 5 days

Group Type: EXPERIMENTAL

Intervention

Intervention Type: OTHER

Shortened antibiotic treatment of 5 days

Control group

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

Group Type: ACTIVE_COMPARATOR

Control

Intervention Type: OTHER

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

Interventions

Intervention

Shortened antibiotic treatment of 5 days

Intervention Type: OTHER

Control

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Thomas Benfield

OTHER

Sponsor Role: lead

Responsible Party

Thomas Benfield

Clinical Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Simone Bastrup Israelsen, MD

Role: PRINCIPAL_INVESTIGATOR

Copenhagen University Hospital - Amager and Hvidovre, Hvidovre, Denmark

Locations

Aalborg University Hospital

Aalborg, , Denmark

Bispebjerg Hospital

Copenhagen, , Denmark

Gentofte Hospital

Gentofte Municipality, , Denmark

Herlev Hospital

Herlev, , Denmark

Nordsjællands Hospital

Hillerød, , Denmark

Hvidovre Hospital

Hvidovre, , Denmark

Odense University Hospital

Odense, , Denmark

Countries

Denmark

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Provided Documents

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

2019-000404-15

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

H-19014479

Identifier Type: -

Identifier Source: org_study_id