Acute leukemia
Conditions
Interventions
Gold Standard:traditional pathogenic test results or clinical final diagnosis
Index test:mNGS detection
Sponsors
Hematology Hospital of Chinese Academy of Medical Sciences
Eligibility
Sex/Gender
All
Age
15 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Patients with acute leukemia aged 15 to 65 years old; 2. Sign written informed consent; 3. Patients should meet one of of the following requirements: (1) Patients with mild fever due to granular deficiency and met the following conditions: 1) Severe neutrophil deficiency (ANC7d or is expected to last >7d; 2) Fever (axillary temperature >=37.5 degree C), accompanied by chills; 3) Patients who have not been treated with antibiotics at the time of enrollment; (2) Patients with septic shock; (3) Suspected fungal pneumonia patients who meet the following conditions: 1) Neutrophil deficiency (ANC<0.5x10^9/L) with fever; 2) Empirical treatment with continuous granular deficiency fever and broad-spectrum antibacterial treatment is ineffective for 4-7 days; 3) CT imaging examination has at least one of the following 4 items: dense, well-defined lesions (with or without Halo sign), air crescent sign, cavity, wedge-shaped, segmental or large leaf consolidation,reverse halo sign (i.e. anti-halo sign).
Exclusion criteria
Exclusion criteria: 1. infection; 2. The pathogen has been diagnosed and antibacterial drugs have been used for more than 3 days, such as fungal infection and tuberculosis infection; 3. The amount of samples is insufficient and the quality of samples is unqualified; 4. HIV patients; 5. Pregnant patients; 6. Patients who take part in other clinical trials; 7. Other situations that the researcher thinks are not suitable for joining the group.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The sensitivity and specificity of mNGS detection; | — |
Countries
China
Contacts
Public ContactJianxiang Wang
Hematology Hospital of Chinese Academy of Medical Sciences
Outcome results
None listed