Clinical Application of High-throughput Sequencing Technology for the Diagnosis of Patients With Severe Infection
Study Details
Study Description
Brief Summary
The purpose of this study is to evaluate the clinical value of high throughput sequencing of infectious pathogens for patients with severe infection, and to establish foundation for high throughput sequencing to be the clinical routine infection pathogen examination. This study is a diagnostic study, and the sample size is 320 cases. 320 participants from the department of hematology and intensive care unit who meet the inclusion criteria are randomly divided into the control group and the experimental group with 160 cases in each group. Both the participants of the control group and the experimental group undergo routine clinical diagnosis methods and treatment. In addition, the participants of the experimental group are collected the samples including whole blood, cerebrospinal fluid or alveolar lavage fluid required for high throughput sequencing of infectious pathogens during sample collection for routine pathogenic examination of infection. The pathogen diagnosis rate and the diagnostic accuracy rate between the conventional infectious pathogen tests and the high throughput sequencing of infectious pathogens will be compared in the experimental group. By gathering statistics of consultation hours and cost efficiency, the effect of high throughput sequencing of infectious pathogens on the diagnosis and treatment efficiency of the experimental group and the control group will be compared, and through these indicators, clinical application value for the diagnosis of severe infection patients by high throughput sequencing of infectious pathogens can be evaluated.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
The purpose of this study is to evaluate the clinical value of high throughput sequencing of infectious pathogens for patients with severe infection, and to establish foundation for high throughput sequencing to be the clinical routine infection pathogen examination.
This study is a diagnostic study, and the sample size is 320 cases. 320 participants from the department of hematology and intensive care unit who meet the inclusion criteria are randomly divided into the control group and the experimental group with 160 cases in each group. Both the participants of the control group and the experimental group undergo routine clinical diagnosis methods and treatment. In addition, the participants of the experimental group are collected the samples including whole blood, cerebrospinal fluid or alveolar lavage fluid required for high throughput sequencing of infectious pathogens during sample collection for routine pathogenic examination of infection. For the experimental group participants, the clinicians will comprehensively determine the follow-up diagnosis methods and treatment according to the clinical routine infection pathogen tests results combining with the results of high throughput sequencing of infectious pathogen, while the control group participants proceed to undergo follow-up diagnosis methods and treatment according to the results of the clinical routine infection pathogen examination. If the results of high throughput sequencing of infectious pathogens of the test group are inconsistent with the results of clinical routine infection pathogen examination, the follow-up diagnosis and treatment of the participants will be based on the results of clinical routine infection pathogen examination with priority.
For sample size assessment, we have predicted the pathogen diagnosis rate of routine clinical pathogen detection methods and high-throughput sequencing of infectious pathogens (α=0.05, β=0.10 (power=0.9)), considering that the maximum rate of missing cases was 20%, and finally got the sample content. And this study will include all subjects selected and randomized into a full analysis set under the intent-to-treat principle. After excluding participants with insufficient sample, withdrawing from the trial midway, giving up treatment and leaving the hospital, or lost to follow-up, the remaining participants will be included in the protocol set under the per-protocol principle.
As for statistical analysis, the pathogen diagnosis rate and the diagnostic accuracy rate between the conventional infectious pathogen tests and the high throughput sequencing of infectious pathogens will be compared in the experimental group. By gathering statistics of consultation hours and cost efficiency, the effect of high throughput sequencing of infectious pathogens on the diagnosis and treatment efficiency of the experimental group and the control group will be compared, and through these indicators, clinical application value for the diagnosis of severe infection patients by high throughput sequencing of infectious pathogens can be evaluated.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: the experimental group high throughput sequencing of infectious pathogens |
Diagnostic Test: PMseqTM high-throughput sequencing technology
high throughput sequencing of infectious pathogens
|
| No Intervention: the control group no intervention |
Outcome Measures
Primary Outcome Measures
- pathogen diagnosis rate [through study completion, an average of half a year]
probability of pathogens detected
- the diagnostic accuracy rate [through study completion, an average of half a year]
probability of diagnosing correctly for high throughput sequencing of infectious pathogen
Secondary Outcome Measures
- money spent by participant [through study completion, an average of half a year]
the money the participant spent during hospitalization
- consultation hours [through study completion, an average of half a year]
time of diagnosis and treatment for the participant
Other Outcome Measures
- the amount and type of antibiotics used [through study completion, an average of half a year]
the amount and type of antibiotics used by participants in the hospital for diagnosis and treatment
- 28-day mortality [through study completion, an average of half a year]
participants mortality within 28 days
- in-hospital mortality [through study completion, an average of half a year]
participants mortality during hospitalization
- anti-infective treatment time [through study completion, an average of half a year]
the time using for treating infection
- the time with effective body temperature control [through study completion, an average of half a year]
the time that body temperature of a participant is effectively and continuously controlled
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Age ≥ 14 years old, male or female
-
Body temperature > 38 ℃
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Newly admitted patients
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The clinician judges that the patient may be infected, and need to undergo the infection pathogen tests
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The patients volunteer to participate in this study and sign informed consent form
Exclusion Criteria:
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Those who do not meet the inclusion criteria
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The patients who can't cooperate
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Zhujiang Hospital
Investigators
- Principal Investigator: Lingxiao Jiang, Division of Laboratory Medicine, Zhujiang Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 20191230