An observational study in Next Generation Sequencing and Infectious Disease, sponsored by Huashan Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-07-27.
Sponsored by Huashan Hospital · Observational
Infectious disease leads to deaths that accounted for more than 25% of all causes of human mortality. But the traditional microbiological diagnostic methods such as specimen culture are sometimes time-consuming, and have limited sensitivity. And some bacteria, anaerobes and viruses may be difficult to cultivate and isolation. Therefore, the accurate identification and rapid classification of pathogenic microorganisms is very important for the patient's precise diagnosis and timely treatment.
Small-scale studies on the diagnostic efficacy and prognosis of infection in the next generation have been shown to provide early diagnosis and targeted medication guidance for bloodstream infections and respiratory infections, but the larger-scale validation of next-generation sequencing Technology in the diagnosis and treatment of infectious diseases in the human body is relatively rare.
The purpose of this study is to provide rapid etiological diagnosis of patients by means of next-generation sequencing, to change the way of treatment of patients under the existing traditional pathogen detection by means of accurate description of pathogens and monitoring their dynamic changes, and to provide patients with more accurate treatment.
4,448 studies on the registry are indexed under Communicable Diseases; 514 are open to participants now.
This study's planned enrollment of 1,500 is above the median of 240 across 1,501 observational studies indexed under Communicable Diseases.
Browse Communicable Diseases studies →Huashan Hospital is the lead sponsor of 246 studies on the registry; 104 are open to participants now.
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Patients that are highly suspected of infectious diseases, and they will be selected mainly from infectious diseases departments .
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To provide rapid etiological diagnosis of patients by means of next-generation sequencing.
Diagnostic value (sensitivity and sensibility, positive/negative predictive value) of next-generation sequencing in the pathogen detection of infectious diseases
We aim to collect samples from patients with fever, bacteremia and bloodstream infections, respiratory infections, central nervous system infections, and abscesses, including blood, cerebrospinal fluid, serous effusion, pus, sputum, alveolar lavage fluid, throat swab. Next-generation sequencing will be performed on the collected samples. Our analysis of the sequencing results will focus on the analysis and identification of pathogen genes and will compare the diagnostic performance of next-generation sequencing with conventional etiological diagnostic methods. We anticipate that next-generation sequencing in infectious patients will show a greater diagnostic value than the traditional methods (including culture, special pathogen serology, PCR detection of nucleic acids, etc.).
Time frame: 3 years
Diagnostic value (sensitivity and sensibility, positive/negative predictive value) of traditional methods in the pathogen detection of infectious diseases
We aim to collect samples from patients with fever, bacteremia and bloodstream infections, respiratory infections, central nervous system infections, and abscesses, including blood, cerebrospinal fluid, serous effusion, pus, sputum, alveolar lavage fluid, throat swab. Traditional methods including culture, special pathogen serology, PCR detection of nucleic acids, etc, will be performed on the collected samples. Our analysis aims to study the diagnostic power of the traditional diagnostic methods in infectious diseases.
Time frame: 3 years
Plan to share: No
Start is estimated for Aug 2017; primary completion for Jul 2020, 35 months later.
Of 579 non-industry observational studies under Communicable Diseases, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 56. This study's planned 35 months is above that.
Counting every sponsor, half of 644 studies reached it within 27 months; a quarter within 13 and three quarters within 54.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Jul 2017. You cannot join it, but the record below documents what was studied.
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