Community-acquired Pneumonia
Conditions
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
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%.
Interventions
OTHERIntervention
Shortened antibiotic treatment of 5 days
OTHERControl
Antibiotic treatment of 7 days or longer at the discretion of the treating physician
Sponsors
Thomas Benfield
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 90-day survival | within 90 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Antibiotic adverse events | within 90 days | Number of participants with adverse events with possible relation to the antibiotic treatment of pneumonia |
| Duration of antibiotic treatment | within 90 days | Days that the participant receives antibiotic treatment for pneumonia, adding intravenous and oral therapy |
| Length of hospital stay | within 90 days | Days from the date of hospital admission for pneumonia to the date of discharge |
| 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 |
| 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 |
| 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 |
| Readmissions | days 30 and 90 | Number of participants with readmissions for reasons related to or unrelated to pneumonia |
| Mortality | in-hospital, days 30 and 90 | Number of deaths by any cause |
| Use of antimicrobials after discharge | within 90 days | Days of antibiotic treatment for any reason after hospital discharge |
Countries
Denmark
Outcome results
None listed