Infections Clinical Trial
Official title:
The Comparison of mNGS Versus Blood Culture for Early Diagnosis of Blood Stream Infection During the Febrile Neutropenia in Patients With Hematological Disease
Blood stream infection (BSI) during febrile neutropenia (FN) is a lethal complication, while confirmed diagnosis via blood culture is usually with low sensitivity and time delay. The new technique of metagenome next generation sequencing (mNGS) has the potential of early and more accurate detection of pathogens. However, this technique has not been well validated for BSI diagnosis in patients with hematological disease. Therefore, we designed a prospective multicenter study to compare the diagnosis performance in BSI.
| Status | Recruiting |
| Enrollment | 300 |
| Est. completion date | August 31, 2022 |
| Est. primary completion date | May 31, 2022 |
| Accepts healthy volunteers | |
| Gender | All |
| Age group | 15 Years and older |
| Eligibility | Inclusion Criteria: - hematologic disease - febrile neutropenia Exclusion Criteria: - refuse to consent - age<=14 - not caused by infection |
| Country | Name | City | State |
|---|---|---|---|
| China | Yuqian Sun | Beijing |
| Lead Sponsor | Collaborator |
|---|---|
| Peking University People's Hospital | Hebei Yanda Ludaopei Hospital, Peking University First Hospital, Peking University International Hospital |
China,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | diagnosis performance | the sensitivity and specificity of mNGS | 14 days after sapmpling |
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