An observational study in Liver Transplant Infection, sponsored by Shenzhen Third People's Hospital. Not yet recruiting at 1 site in China. Per ClinicalTrials.gov, last updated 2024-08-07.
Sponsored by Shenzhen Third People's Hospital · Observational
Infection post liver transplantation is an important factor in the death in patients. The traditional method of diagnosing infection post liver transplantation is laboratory tests. But the sensitivity and specificity of blood tests is poor. Next-generation sequencing (NGS) has greater detection rate for mycobacterium tuberculosis, anaerobes and fungi and greater sensitivity compare with blood tests. However use of NGS is limited because of the short read-length. Oxford nanopore adaptive sequencing (NAS) method is the Third Revolution in Sequencing Technology. For each 1 Gbp of data, NAS sequencing detected 45 times more microbiome sequences than Nanopore standard sequencing and 2.5 times more than Illumina sequencing. The purpose of this study is to compare NAS with NGS and laboratory tests for the diagnostic rate of infection post liver transplantation.
Based on the previous work, the investigators found that: 1. NAS has a higher microbial enrichment efficiency and can detect pathogenic information more quickly compared with nanopores normal sequencing (NNS); 2. NAS can detect more specific pathogen fragments with short-time sequencing; 3. NAS can cover more pathogenic genomes than NNS in a short-time; 4. NAS can detect antibiotic resistance information of pathogenic bacteria in clinical samples.
Shenzhen Third People's Hospital is the lead sponsor of 10 studies on the registry; 9 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Participants will be recruited randomly and if they violate the protocol or occur clinical adverse events, the investigators will ask them to withdraw from this study.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
In this group, the investigators will detect the number of pathogen in alveolar lavage fluid, blood and peritoneal drainage by using NAS.
Diagnostic Test: NAS, NGS and Laboratory tests
In this group, the investigators will detect the number of pathogen in alveolar lavage fluid, blood and peritoneal drainage by using NGS.
Diagnostic Test: NAS, NGS and Laboratory tests
In this group, the investigators will detect the number of pathogen in alveolar lavage fluid, blood and peritoneal drainage by using laboratory tests.
Diagnostic Test: NAS, NGS and Laboratory tests
Using three diffrent detection methods and comparing their efficiency
Diagnosed infection post liver transplantation
Any pathogens are detected in alveolar lavage fluid, peritoneal drainage or blood before patients discharge from hospital, an average of 1 months
Time frame: Post liver transplantation before patients discharge from hospital, an average of 1 months.
Plan to share: No
This study is not yet recruiting, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.
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Shenzhen Third People's Hospital