An observational study in Infectious Disease, sponsored by Children's Hospital of Fudan University. Recruiting at 1 site in China. Open to participants aged Up to 16 Years. Per ClinicalTrials.gov, last updated 2024-05-13.
Sponsored by Children's Hospital of Fudan University · Observational
Infectious diseases remain leading causes of mortality and morbidity in children. Rapid and accurate diagnosis of infectious diseases in children is important for developing an effective treatment and management strategy. However, the current diagnosis of infectious agents mainly depends on culture and molecular testing. Both of the methods either has long turnaround times or narrow detection range. Metagenome next generation sequencing (mNGS) has been applied to the diagnosis of central nervous system infection, lower respiratory tract infection and sepsis, which showed high positive rate, short turnaround time. However, there is currently no assessment of the diagnostic efficacy of mNGS in children infectious diseases. This study used the DNA extraction and library construction technology developed for children's low volume clinical samples to assess the sensitivity and specificity of mNGS in the diagnosis of infectious diseases, and the treatment outcome based on mNGS test results.
4,452 studies on the registry are indexed under Communicable Diseases; 521 are open to participants now.
This study's planned enrollment of 1,000 is above the median of 244 across 1,499 observational studies indexed under Communicable Diseases.
Browse Communicable Diseases studies →Children's Hospital of Fudan University is the lead sponsor of 262 studies on the registry; 92 are open to participants now.
Counted across the registry records on this site, refreshed daily.
This study mainly focus on the pediatric patients who is suspected of infectious disease.
Exclusion Criteria:
Using mNGS to diagnosis infectious disease of this group
Other: no intervention
It's only observational study. No interventions.
The sensitivity of metagenome next generation sequencing in the diagnosis of pediatric infectious disease
Samples from patients, who is suspected to central nervous system infection, respiratory infection, bloodstream infection and other unknown infections, will be tested by mNGS and traditional methods simultaneously. The sensitivity value will be calculated by comparing the detecting results of mNGS and traditional detecting methods.
Time frame: From the date of first samples enrolled until the last samples detected, up to 3 years
The specificity of metagenome next generation sequencing in the diagnosis of pediatric infectious disease
Samples from patients, who is suspected to central nervous system infection, respiratory infection, bloodstream infection and other unknown infections, will be tested by mNGS and traditional methods simultaneously. The specificity value will be calculated by comparing the detecting results of mNGS and traditional detecting methods.
Time frame: From the date of first samples enrolled until the last samples detected, up to 3 years
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Children's Hospital of Fudan University