Anti-infection Therapy Based on mNGS Etiological Diagnosis and Infection After Liver Transplantation

NCT06212115 | Not Yet Recruiting DMC

• 1 other identifier: SZSPH-LT-mNGS
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

Liver transplantation is the most efficacious treatment for end-stage liver disease; however, postoperative infection remains a major complication and leading cause of recipient mortality. Specifically, infections originating from donors, particularly those caused by multidrug-resistant bacteria, can significantly impact the prognosis of liver transplant recipients. Theoretically, implementing targeted antimicrobial therapy for donors prior to organ donation could reduce the likelihood of pathogen transmission with the transplanted organ, thereby potentially decreasing the incidence of post-transplant infections from donor sources and improving recipient outcomes. Nevertheless, there is currently a dearth of high-quality prospective studies in this domain. Our previous investigation (Front Microbiol. 2022 Jul 1;13:919363) demonstrated that second-generation metagenomic sequencing (mNGS) technology holds substantial value in expeditious pathogen screening following liver transplantation. Prompt implementation of targeted treatment based on microbiological findings has shown potential to enhance outcomes for select recipients. Therefore, this study aims to provide tailored treatment for donors based on microbiological examination results (including mNGS detection and culture results), analyze corresponding data regarding recipient infection occurrence and prognosis, and explore the impact of mNGS-guided donor antimicrobial therapy on perioperative infection rates among liver transplant recipients.

Conditions

Infection

Outcome Measures

Primary Outcomes (1)

• Infection

  The diagnosis of infection relies on a comprehensive assessment of clinical manifestations, microbiological test results, imaging examinations, and related laboratory tests. In our study, this diagnosis was established by a team of infectious disease specialists and organ transplant physicians. Donor-derived infection occurs when pathogens present in the donor's body post-organ procurement lead to the recipient contracting an infection with the same pathogens during the organ transplantation process.

  The study focused on the incidence of infection and the postoperative prognosis of transplant recipients within 30 days

Study Arms (2)

donor-mNGS-testing group

Organ donors are treated with mNGS testing before organ donation

Diagnostic Test: mNGS

donor-non-mNGS-testing group

Organ donors are not treated with mNGS testing before organ donation

Interventions

mNGS DIAGNOSTIC_TEST

metagenomics next generation sequencing

donor-mNGS-testing group

Eligibility Criteria

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

Study Population

Patients treated with Liver transplantation

You may qualify if:

• Recipient age \>18 years;
• Clinical diagnosis of infection in the donor with administered anti-infective treatment;
• Complete clinical data for both the donor and recipient.

You may not qualify if:

• Recipient age \<18 years;
• Presence of surgery-related factors leading to death or infection, such as intraoperative cardiac arrest resulting in postoperative death, intraoperative bleeding exceeding 2000ml, postoperative complications like intestinal or bile leakage, graft dysfunction, or small liver syndrome;
• Incomplete clinical data for the donor or recipient

Sponsors & Collaborators

• Shenzhen Third People's Hospital: lead

Study Sites (1)

Shenzhen Third People's Hospital

Shenzhen, Shenzhen, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

Bronchoalveolar lavage fluid, blood

MeSH Terms

Conditions

Infections

Study Officials

• Dong Zhao, Dr.

  Shenzhen Third People's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dong Zhao, Dr.

CONTACT

13631508530; zdong1233@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 26, 2023
• First Posted: January 18, 2024
• Study Start: February 1, 2024
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2027
• Last Updated: January 19, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)