Next Generation Pathogen Sequencing for Prediction of Infection in Rheumatic Disease

NCT04226261 | Unknown

• 1 other identifier: NGPSPIRD
• Study Type: observational
• Target: 200
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Infection

Outcome Measures

Primary Outcomes (2)

• 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)

• 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)

Eligibility Criteria

• Age: 16 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants who are being treated at Peking University People's Hospital and who have a high risk of infection.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Peking University People's Hospital: lead

Related 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. 2020 Apr 1;6(4):552-556. doi: 10.1001/jamaoncol.2019.4120.

  PMID: 31855231 BACKGROUND

Related Links

• Next Generation Pathogen Sequencing for Prediction of Adverse Events

Biospecimen

Retention: SAMPLES WITH DNA

Plasma or serum samples collected but not required for clinical care will undergo next generation pathogen sequencing.

MeSH Terms

Conditions

Infections

Study Officials

• Zhanguo Li, M.D, Ph.D

  Peking University People's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhanguo Li, M.D, Ph.D

CONTACT

+8601088324317; li99@bjmu.edu.cn

Jiali Chen, M.D

CONTACT

+8618801206400; chenjiali0389@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2020
• First Posted: January 13, 2020
• Study Start: January 15, 2020
• Primary Completion: January 15, 2021
• Study Completion: June 15, 2021
• Last Updated: January 13, 2020

Record last verified: 2020-01