Background: Community-acquired pneumonia (CAP) continues to be a major health problem with significant mortality and it's one of the main causes of antibiotic prescription. Antibiotic overuse is a key driver of antimicrobial resistance and exposes patients to an increased risk of other antibiotic-related adverse events. The investigators aim to assess if rapid molecular tests are an effective tool to reduce antibiotic use in CAP compared to routine microbiological testing. Design: Randomized, controlled, open-label clinical trial with two parallel groups (1:1) settled in a two-year multicenter, two tertiary care hospitals, between 2019 and 2021. Eligible participants will be non-severely immunosuppressed adult patients hospitalized for CAP through the emergency department. Primary endpoint will be antibiotic consumption measured by days of antibiotic therapy (DOT) per 1000 patient-days. Secondary end points will be: de-escalation to narrower antibiotic treatment, time to switch from intravenous to oral antibiotics, antibiotic-related side effects, length of hospital stay, days until clinical stability, need for ICU admission, need for hospital readmission in the 30 days after randomization, death from any cause in the 30 days after randomization. Patients will be randomly assigned to receive experimental diagnosis (comprehensive molecular testing added to routine microbiological testing) or standard diagnosis (only microbiological routine testing). A total of 220 patients are estimated in the experimental arm (undergoing comprehensive molecular testing) and 220 control subjects (undergoing routine testing) to be able to reject the null hypothesis that experimental and control groups have equal DOT per 1000 patients-days with a probability above 0.8. Discussion: Comprehensive molecular tests could be a key tool in the optimization of etiological diagnostics in CAP and, therefore, a key element in antimicrobial stewardship programs developed to improve safety and antibiotic use in CAP.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
242
Patients will be randomly assigned to receive experimental diagnosis (comprehensive molecular testing added to routine microbiological testing) AND standard diagnosis microbiological procedures
Patients who will undergo only the standard microbiological diagnostic procedures: blood cultures, Gram stain and culture sputum when possible, Gram and pleural fluid culture when appropriate, urine determination of the pneumococcal and Legionella pneumophila serogroup antigens type 1. A serological study will be carried out for the etiological agents of atypical pneumonia in the acute and convalescent phases of the infection.
Hospital Germans Trias i Pujol
Badalona, Barcelona, Spain
Moisés Broggi University Hospital
Sant Joan Despí, Barcelona, Spain
SCIAS Hospital de Barcelona
Barcelona, Catalonia, Spain
Hospital de Bellvitge
Barcelona, Spain
Number of DOT
Number of days of antibiotic therapy
Time frame: Up to 30±5 days after hospital discharge
Number of days with intravenous antibiotic treatment.
Number of days of intravenous antibiotic treatment
Time frame: Up to 30±5 days after hospital discharge
Number of days until de-escalation
Number of days until de-escalation of antibiotic treatment to another of narrower spectrum
Time frame: Up to 30±5 days after hospital discharge
Number of days until antimicrobial monotherapy
Number of days untilt antimicrobial monotherapy
Time frame: Up to 30±5 days after hospital discharge
Number of days until etiological diagnosis
Number of days until detection of the causal agent
Time frame: Up to 30±5 days after hospital discharge
Number of days of Oxygen treatment
Days of oxygen treatment
Time frame: Up to 30±5 days after hospital discharge
Number of days of non-invasive ventilation
Days of invasive or non-invasive mechanical ventilation
Time frame: Up to 30±5 days after hospital discharge
Number of days of hospital admission
Number of days of hospital admission
Time frame: Up to hospital discharge - a medium of 5 days
Rate of readmissions
Rate of patients who are readmitted after hospital discharge
Time frame: Up to 30±5 days after hospital discharge
Rate of complicated community-acquired pneumonia (CAP)
Rate of complications related to CAP
Time frame: Up to 30±5 days after hospital discharge
Rate of general complications
Patients with medical complications not directly related to CAP until the end of the clinical trial.
Time frame: Up to 30±5 days after hospital discharge
Number of adverse events
Number of total adverse events.
Time frame: Up to 30±5 days after hospital discharge
Number of adverse events related to antimicrobials
Number of adverse events related to antibiotic therapy.
Time frame: Up to 30±5 days after hospital discharge
Number of participants with Clostridium difficile infection
Number of patients diagnosed with Clostridium difficile infection during the clinical trial.
Time frame: Up to 30±5 days after hospital discharge
Phlebitis rate
Number of patients with phlebitis resulting from the use of intravenous drugs.
Time frame: Up to 30±5 days after hospital discharge
Early mortality rate
Number of patients deceased 5 days after the randomization
Time frame: Up tp 5 days after randomization
30 day case-fatality rate
Number of patients deceased 30±5 days after randomization
Time frame: Up to 30±5 days after randomization
CAP-related fatality rate
Number of patients Deceased patients, related to CAP during the clinical trial
Time frame: Up to 30±5 days after hospital discharge
All-cause fatality rate
Number of patients who died from any cause during the clinical trial
Time frame: Up to 30±5 days after hospital discharge
Number of DOT per 1000 patients-day
Number of Days of antibiotic treatment per 1000 patients-day
Time frame: Up to 30±5 days after hospital discharge
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