Next Generation Pathogen Sequencing for Prediction of Infection in Rheumatic Disease

Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04226261
• Other study ID #: NGPSPIRD
• Status: Not yet recruiting
• Start date: January 15, 2020
• Est. completion date: June 15, 2021

Study information

• Verified date: January 2020
• Source: Peking University People's Hospital
• Contact: Zhanguo Li, M.D, Ph.D
• Phone: +8601088324317
• Email: li99[@]bjmu.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: June 15, 2021
• Est. primary completion date: January 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Collagen Diseases
• Communicable Diseases
• Infection
• Rheumatic Diseases

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Peking University People's Hospital

References & Publications (1)

Goggin KP, Gonzalez-Pena V, Inaba Y, Allison KJ, Hong DK, Ahmed AA, Hollemon D, Natarajan S, Mahmud O, Kuenzinger W, Youssef S, Brenner A, Maron G, Choi J, Rubnitz JE, Sun Y, Tang L, Wolf J, Gawad C. Evaluation of Plasma Microbial Cell-Free DNA Sequencing to Predict Bloodstream Infection in Pediatric Patients With Relapsed or Refractory Cancer. JAMA Oncol. 2019 Dec 19. doi: 10.1001/jamaoncol.2019.4120. [Epub ahead of print] — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of NGS-positive results	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.	Once (within 72 hours of enrollment)
Primary	Proportion of NGS-negative results	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.	Once (within 72 hours of enrollment)

External Links

•   Next Generation Pathogen Sequencing for Prediction of Adverse Events