NCT06172153

Brief Summary

Comparing the diagnostic efficacy between traditional laboratory methods and second-generation high-throughput sequencing in patients suspected of spinal infections.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2023

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

December 7, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 15, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2024

Completed
Last Updated

December 15, 2023

Status Verified

December 1, 2023

Enrollment Period

11 months

First QC Date

December 7, 2023

Last Update Submit

December 14, 2023

Conditions

Spinal InfectionDiagnositic Efficacy

Outcome Measures

Primary Outcomes (2)

  • The diagnositic efficacy

    Sensitivity, Specificity

    1 year

  • The diagnositic efficacy

    Positive Predictive Value, Negative Predictive Value

    1 year

Study Arms (1)

Sun Yat-sen memorial hospital

Patients who were suspected of Spinal infection.

Other: No interventions

Interventions

No interventionsOTHER

No intervention

Sun Yat-sen memorial hospital

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

"The patients suspected of spinal infections were admitted to the Orthopedic Department of Sun Yat-sen Memorial Hospital, Sun Yat-sen University."

You may qualify if:

  • "Patients suspected of spinal infections, as per the American Infectious Diseases Society's 2015 criteria for primary vertebral osteomyelitis, were identified based on their clinical symptoms, laboratory tests, and imaging examinations. All cases included in the study underwent laboratory examinations, histopathological examinations, and second-generation high-throughput sequencing (metagenomic sequencing)."

You may not qualify if:

  • "The absence of laboratory examinations, histopathological examinations, and results from second-generation high-throughput sequencing (metagenomic sequencing)."

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sun Yat-sen memorial hospital

Guangzhou, Guangdong, 510000, China

RECRUITING

Study Officials

  • Chunhai Li, MD

    Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Chunhai Li, MD

CONTACT

18602079796lichhai@mail.sysu.edu.cn

hanwen cheng, Master

CONTACT

19541080926chenghw3@mail2.sysu.edu.cn

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 7, 2023

First Posted

December 15, 2023

Study Start

June 1, 2023

Primary Completion

May 1, 2024

Study Completion

May 1, 2024

Last Updated

December 15, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)