Developed by Shray Alag, The Harker School
Sections: Correlations,
Clinical Trials, and HPO
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There is one clinical trial.
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.
Description: Number of days of antibiotic therapy per 1000 patient-days
Measure: Number of DOT/1000 patients Time: Up to 30±5 days after hospital dischargeDescription: Number of days of intravenous antibiotic treatment
Measure: Number of days with intravenous antibiotic treatment. Time: Up to 30±5 days after hospital dischargeDescription: Number of days until de-escalation of antibiotic treatment to another of narrower spectrum
Measure: Number of days until de-escalation Time: Up to 30±5 days after hospital dischargeDescription: Number of days untilt antimicrobial monotherapy
Measure: Number of days until antimicrobial monotherapy Time: Up to 30±5 days after hospital dischargeDescription: Number of days until detection of the causal agent
Measure: Number of days until etiological diagnosis Time: Up to 30±5 days after hospital dischargeDescription: Days of oxygen treatment
Measure: Number of days of Oxygen treatment Time: Up to 30±5 days after hospital dischargeDescription: Days of invasive or non-invasive mechanical ventilation
Measure: Number of days of non-invasive ventilation Time: Up to 30±5 days after hospital dischargeDescription: Number of days of hospital admission
Measure: Number of days of hospital admission Time: Up to hospital discharge - a medium of 5 daysDescription: Rate of patients who are readmitted after hospital discharge
Measure: Rate of readmissions Time: Up to 30±5 days after hospital dischargeDescription: Rate of complications related to CAP
Measure: Rate of complicated community-acquired pneumonia (CAP) Time: Up to 30±5 days after hospital dischargeDescription: Patients with medical complications not directly related to CAP until the end of the clinical trial.
Measure: Rate of general complications Time: Up to 30±5 days after hospital dischargeDescription: Number of total adverse events.
Measure: Number of adverse events Time: Up to 30±5 days after hospital dischargeDescription: Number of adverse events related to antibiotic therapy.
Measure: Number of adverse events related to antimicrobials Time: Up to 30±5 days after hospital dischargeDescription: Number of patients diagnosed with Clostridium difficile infection during the clinical trial.
Measure: Number of participants with Clostridium difficile infection Time: Up to 30±5 days after hospital dischargeDescription: Number of patients with phlebitis resulting from the use of intravenous drugs.
Measure: Phlebitis rate Time: Up to 30±5 days after hospital dischargeDescription: Number of patients deceased 5 days after the randomization
Measure: Early mortality rate Time: Up tp 5 days after randomizationDescription: Number of patients deceased 30±5 days after randomization
Measure: 30 day case-fatality rate Time: Up to 30±5 days after randomizationDescription: Number of patients Deceased patients, related to CAP during the clinical trial
Measure: CAP-related fatality rate Time: Up to 30±5 days after hospital dischargeDescription: Number of patients who died from any cause during the clinical trial
Measure: All-cause fatality rate Time: Up to 30±5 days after hospital dischargeAlphabetical listing of all HPO terms. Navigate: Correlations Clinical Trials
Data processed on December 13, 2020.
An HTML report was created for each of the unique drugs, MeSH, and HPO terms associated with COVID-19 clinical trials. Each report contains a list of either the drug, the MeSH terms, or the HPO terms. All of the terms in a category are displayed on the left-hand side of the report to enable easy navigation, and the reports contain a list of correlated drugs, MeSH, and HPO terms. Further, all reports contain the details of the clinical trials in which the term is referenced. Every clinical trial report shows the mapped HPO and MeSH terms, which are also hyperlinked. Related HPO terms, with their associated genes, protein mutations, and SNPs are also referenced in the report.
Drug Reports MeSH Reports HPO Reports