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Next Generation Pathogen Sequencing for Prediction of Infection in Rheumatic Disease

Prediction of Infection in Patients With Rheumatic Disease at High Risk of Infection

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04226261
Enrollment
200
Registered
2020-01-13
Start date
2020-01-15
Completion date
2021-06-15
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infection

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.

Interventions

None listed

Sponsors

Peking University People's Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
16 Years to 70 Years
Healthy volunteers
No

Inclusion criteria

* 18 years to 70 years; * Undergoing care for rheumatic disease at Peking University People's Hospital; * In a category of patients who are considered by the investigator to be at high risk of infection

Exclusion criteria

* Any condition that would, in the opinion of the investigator, place the subject at an unacceptable risk of injury or render the subject unable to meet the requirements of the protocol

Design outcomes

Primary

MeasureTime frameDescription
Proportion of NGS-positive resultsOnce (within 72 hours of enrollment)To estimate the sensitivity of next generation pathogen sequencing for prediction of infection, the proportion of NGS-positive results in all positive infection will be given.
Proportion of NGS-negative resultsOnce (within 72 hours of enrollment)To estimate the specificity of next generation pathogen sequencing for prediction of infection, the proportion of NGS-negative results in all negative infection will be given.

Contacts

Primary ContactZhanguo Li, M.D, Ph.D
li99@bjmu.edu.cn+8601088324317
Backup ContactJiali Chen, M.D
chenjiali0389@163.com+8618801206400

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026