Clinical trial NCT04217252: Clinical Application of High-throughput Sequencing Technology for the Diagnosis of Patients With Severe Infection
Official title: Clinical Application of High-throughput Sequencing Technology for the Diagnosis of Patients With Severe Infection
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Infection
Keywords: severe infection
high throughput sequencing
infectious pathogen
Lead sponsor: Zhujiang Hospital
Sponsor class: OTHER
First posted: 2020-01-03
Enrollment: 0
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The 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. 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.
Primary purpose: DIAGNOSTIC

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.

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.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 14 years old, male or female
* Body temperature \> 38 ℃
* Newly admitted patients
* The clinician judges that the patient may be infected, and need to undergo the infection pathogen tests
* The patients volunteer to participate in this study and sign informed consent form

Exclusion Criteria:

* Those who do not meet the inclusion criteria
* The patients who can't cooperate

Primary outcomes:
measure: pathogen diagnosis rate
timeFrame: through study completion, an average of half a year
measure: the diagnostic accuracy rate
timeFrame: through study completion, an average of half a year
Secondary outcomes:
measure: money spent by participant
timeFrame: through study completion, an average of half a year
measure: consultation hours
timeFrame: through study completion, an average of half a year
Other outcomes:
measure: the amount and type of antibiotics used
timeFrame: through study completion, an average of half a year
measure: 28-day mortality
timeFrame: through study completion, an average of half a year
measure: in-hospital mortality
timeFrame: through study completion, an average of half a year
measure: anti-infective treatment time
timeFrame: through study completion, an average of half a year
measure: the time with effective body temperature control
timeFrame: through study completion, an average of half a year
Locations:
Study officials:
affiliation: Division of Laboratory Medicine, Zhujiang Hospital
name: Lingxiao Jiang
role: PRINCIPAL_INVESTIGATOR
References: