Status:
COMPLETED
Shortened Antibiotic Treatment of 5 Days in Community-Acquired Pneumonia
Lead Sponsor:
Thomas Benfield
Conditions:
Community-acquired Pneumonia
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 18 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 22 2025
Estimated Enrollment :
395 Patients enrolled
Trial Details
Trial ID
NCT04089787
Start Date
September 18 2019
End Date
January 22 2025
Last Update
April 3 2025
Active Locations (7)
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1
Aalborg University Hospital
Aalborg, Denmark, 9000
2
Bispebjerg Hospital
Copenhagen, Denmark, 2400
3
Gentofte Hospital
Gentofte Municipality, Denmark, 2900
4
Herlev Hospital
Herlev, Denmark, 2730