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

Thomas Benfield

Status and phase

Completed

Phase 4

Conditions

Community-acquired Pneumonia

Treatments

Other: Control

Other: Intervention

Study type

Interventional

Funder types

Other

Identifiers

NCT04089787

H-19014479

2019-000404-15 (EudraCT Number)

Details and patient eligibility

About

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%.

Enrollment

395 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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