Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 11:50 AM
Ignite Modification Date:
2025-12-24 @ 11:50 AM
NCT ID:
NCT04226261
Brief Summary:
The majority of patients diagnosed with rheumatic disease, such as systemic lupus erythematosus, inflammatory myositis, and vasculitis, will experience fever or infection during their course of therapy. The most common microbiologically documented infection is bacterial, virus, and fungal, which can be associated with the severity and mortality of disease. Current methods of diagnosis require a significant load of pathogen making early detection difficult. Delayed diagnosis and delayed optimal therapy of infection are associated with increased morbidity and mortality.
This study seeks to identify whether next generation sequencing (NGS) of pathogens can identify patients with infection treated with corticosteroid and immunosuppressive agents. This would enable preemptive targeted therapy to replace prophylaxis treatment which often leads to some adverse events and antibiotic resistance.
Detailed Description:
Plasma/Serum samples collected but not required for clinical care (discarded samples) will be collected and stored. Results of NGS will be compared between patients who develop definite infection immediately (within 72 hours) after sample collection, and those who remain well. Clinical data describing baseline information about the patient and rheumatic diseases, antibiotic and steroid or immunosuppressor therapy exposure, pathogen testing, immunology results, and infection-related events will be collected prospectively from the electronic medical record.
An initial exploratory phase will examine approximately 50 participants to determine whether the effectiveness of predicting infections. The study may then enroll up to 200 participants to collection additional data for analysis.
Study:
NCT04226261
Study Brief:
Protocol Section:
NCT04226261