Clinical trial NCT04089787: Shortened Antibiotic Treatment of 5 Days in Community-Acquired Pneumonia
Official title: Shortened Antibiotic Treatment in Community-Acquired Pneumonia: A Nationwide Danish Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Community-acquired Pneumonia
Keywords: Community-acquired pneumonia
Treatment duration
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Bacterial Infections
Pneumonia, Bacterial
Anti-Infective Agents
Anti-Bacterial Agents
Lead sponsor: Hvidovre University Hospital
Sponsor class: OTHER
First posted: 2019-09-13
Enrollment: 395
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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%.


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

Primary outcomes:
measure: 90-day survival
timeFrame: within 90 days
Secondary outcomes:
measure: Duration of antibiotic treatment
timeFrame: within 90 days
measure: Length of hospital stay
timeFrame: within 90 days
measure: Antibiotic adverse events
timeFrame: within 90 days
measure: Serious adverse events
timeFrame: within 90 days
measure: Major complications
timeFrame: within 90 days
measure: Use of antimicrobials after discharge
timeFrame: within 90 days
measure: Post-discharge follow-up visits
timeFrame: within 90 days
measure: Readmissions
timeFrame: days 30 and 90
measure: Mortality
timeFrame: in-hospital, days 30 and 90
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: Aalborg University Hospital
city: Copenhagen
country: Denmark
facility: Bispebjerg Hospital
city: Gentofte
country: Denmark
facility: Gentofte Hospital
city: Herlev
country: Denmark
facility: Herlev Hospital
city: Hillerød
country: Denmark
facility: Nordsjællands Hospital
city: Hvidovre
country: Denmark
facility: Hvidovre Hospital
city: Odense
country: Denmark
facility: Odense University Hospital
Study officials:
affiliation: Copenhagen University Hospital - Amager and Hvidovre, Hvidovre, Denmark
name: Simone Bastrup Israelsen, MD
role: PRINCIPAL_INVESTIGATOR
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