Impact of Comprehensive Molecular Tests on Antimicrobial Stewardship in Community-acquired Pneumonia
- Conditions
- Community-acquired Pneumonia
- Interventions
- Diagnostic Test: real-time multiplex PCRDiagnostic Test: Standard diagnostic procedures
- Registration Number
- NCT04158492
- Lead Sponsor
- Hospital Universitari de Bellvitge
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 242
- Adult patients (18 years of age or older), of both sexes, hospitalized with a diagnosis of CAP in the first 24 hours of the admission.
- Patient or his legal representative gives the informed consent
-
Patient with acute infection by SARS-CoV-2 being this defined as:
- Clinic of COVID-19 compatible, PCR positive for SARS-CoV-2 and negative serology for SARS-CoV-2.
OR
-
COVID-19 clinic compatible, PCR positive for SARS-CoV-2 (in the last 60 days) and positive serology for SARS-CoV-2.
- Pregnancy and / or nursing.
- Severe immunocompromised patients (chemotherapy or radiotherapy in the previous 90 days, use of immunosuppressive drugs, chronic use of corticosteroids at a minimum dose of 15 mg / day in the last two weeks, transplantation of hematopoietic progenitors, solid organ transplant, patients with HIV and CD4 count ≤ 200 cells / mm3).
- Imminent death (life expectancy ≤ 24 hours).
- Participation in another clinical trial of pharmacological treatment during the previous 3 months.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Experimental + standard diagnostic tests real-time multiplex PCR Patients will undergo described standard diagnostic procedures and in addition, real-time multiplex Protein Chain Reaction (PCR, FilmArray Pneumonia panel Plus ™, Biofire, BioMérieux). Standard diagnostic tests Standard diagnostic procedures Patients who will undergo only the standard diagnostic procedures
- Primary Outcome Measures
Name Time Method Number of DOT Up to 30±5 days after hospital discharge Number of days of antibiotic therapy
- Secondary Outcome Measures
Name Time Method Number of days until de-escalation Up to 30±5 days after hospital discharge Number of days until de-escalation of antibiotic treatment to another of narrower spectrum
Number of days with intravenous antibiotic treatment. Up to 30±5 days after hospital discharge Number of days of intravenous antibiotic treatment
Rate of complicated community-acquired pneumonia (CAP) Up to 30±5 days after hospital discharge Rate of complications related to CAP
Rate of general complications Up to 30±5 days after hospital discharge Patients with medical complications not directly related to CAP until the end of the clinical trial.
Number of adverse events related to antimicrobials Up to 30±5 days after hospital discharge Number of adverse events related to antibiotic therapy.
Number of participants with Clostridium difficile infection Up to 30±5 days after hospital discharge Number of patients diagnosed with Clostridium difficile infection during the clinical trial.
Phlebitis rate Up to 30±5 days after hospital discharge Number of patients with phlebitis resulting from the use of intravenous drugs.
Number of days of non-invasive ventilation Up to 30±5 days after hospital discharge Days of invasive or non-invasive mechanical ventilation
Number of days of hospital admission Up to hospital discharge - a medium of 5 days Number of days of hospital admission
30 day case-fatality rate Up to 30±5 days after randomization Number of patients deceased 30±5 days after randomization
CAP-related fatality rate Up to 30±5 days after hospital discharge Number of patients Deceased patients, related to CAP during the clinical trial
Rate of readmissions Up to 30±5 days after hospital discharge Rate of patients who are readmitted after hospital discharge
Number of adverse events Up to 30±5 days after hospital discharge Number of total adverse events.
All-cause fatality rate Up to 30±5 days after hospital discharge Number of patients who died from any cause during the clinical trial
Number of days until antimicrobial monotherapy Up to 30±5 days after hospital discharge Number of days untilt antimicrobial monotherapy
Number of days until etiological diagnosis Up to 30±5 days after hospital discharge Number of days until detection of the causal agent
Number of days of Oxygen treatment Up to 30±5 days after hospital discharge Days of oxygen treatment
Early mortality rate Up tp 5 days after randomization Number of patients deceased 5 days after the randomization
Number of DOT per 1000 patients-day Up to 30±5 days after hospital discharge Number of Days of antibiotic treatment per 1000 patients-day
Trial Locations
- Locations (4)
Hospital Germans Trias i Pujol
🇪🇸Badalona, Barcelona, Spain
Moisés Broggi University Hospital
🇪🇸Sant Joan Despí, Barcelona, Spain
SCIAS Hospital de Barcelona
🇪🇸Barcelona, Cataluña, Spain
Hospital de Bellvitge
🇪🇸Barcelona, Spain