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This study aims to observe the effectiveness of clinical application in guiding anti-infection treatments in AIDS patients with severe pneumonia and/or sepsis using Metagenomic Next-Generation Sequencing-based technology in the real world
The study focuses on AIDS patients with severe pneumonia and/or sepsis, divided into groups based on whether metagenomic next-generation sequencing technology is used in the real world or not. The groups are the metagenomic next-generation sequencing group and the conventional pathogen detection group, with metagenomic sequencing samples derived from blood specimens. The study compares the pathogen detection rates and clinical diagnosis conformity rates of the aforementioned groups, as well as the efficiency of diagnosis in guiding clinical treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pathogen metagenomic next-generation sequencing group | This group uses metagenomic next-generation sequencing along with traditional pathogen detection techniques to test for infectious pathogens. The follow-up times are the 1st, 2nd, 3rd, and 4th weeks after being diagnosed with severe pneumonia or sepsis. |
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| Conventional pathogen detection group | This group only used conventional pathogen detection methods for the identification of infectious pathogens. Follow-up was conducted at the 1st, 2nd, 3rd, and 4th weeks after the diagnosis of severe pneumonia or sepsis. The conventional means of pathogen detection include, but are not limited to, fungal serology tests, cryptococcal capsular antigen detection, CMV-DNA tests, sputum smear microscopy, gamma interferon release assays, Xpert MTB/RIF, BLAF culture, blood and bone marrow cultures, radiological examinations, and histopathological examinations. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pathogen metagenomic next-generation sequencing | Diagnostic Test | In diagnosing patients with AIDS combined with severe pneumonia and/or sepsis, use pathogen metagenomics technology to detect peripheral blood specimens |
| Measure | Description | Time Frame |
|---|---|---|
| Pathogen detection rate and clinical diagnosis concordance rate | Analyze the concordance rate between the pathogen spectrum detected using pathogen metagenomics technology and the final clinical disease diagnosis. | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical treatment efficacy rate | "Clinical treatment efficacy includes: 1) AIDS combined with severe pneumonia: pathogen clearance or quantitative change, PSI score, chest X-ray/chest CT; 2) AIDS combined with sepsis: pathogen clearance or quantitative change, SOFA score. | 4 weeks |
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Inclusion Criteria:
Confirmed HIV infection;
Progression to AIDS stage: CD4+ count <200 cells/ul and/or occurrence of AIDS opportunistic infections;
Age between 18 and 65 years;
Meeting the diagnosis of severe pneumonia or septic shock:
Exclusion Criteria:
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All study participants come from the OSPWH (Patients With HIV/AIDS) cohort at the Guangzhou Eighth People's Hospital.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Linghua Li | Recruiting | Guangzhou | Guangdong | 510060 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32016535 | Result | Barbier F, Mer M, Szychowiak P, Miller RF, Mariotte E, Galicier L, Bouadma L, Tattevin P, Azoulay E. Management of HIV-infected patients in the intensive care unit. Intensive Care Med. 2020 Feb;46(2):329-342. doi: 10.1007/s00134-020-05945-3. Epub 2020 Feb 3. | |
| 29074157 | Result | Besser J, Carleton HA, Gerner-Smidt P, Lindsey RL, Trees E. Next-generation sequencing technologies and their application to the study and control of bacterial infections. Clin Microbiol Infect. 2018 Apr;24(4):335-341. doi: 10.1016/j.cmi.2017.10.013. Epub 2017 Oct 23. |
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| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| D011014 | Pneumonia |
| D000071074 | Neonatal Sepsis |
| D018805 | Sepsis |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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Reserved biological samples are derived from peripheral blood specimens, used for pathogen metagenomic next-generation sequencing.
| 36567402 | Result | Pei F, Yao RQ, Ren C, Bahrami S, Billiar TR, Chaudry IH, Chen DC, Chen XL, Cui N, Fang XM, Kang Y, Li WQ, Li WX, Liang HP, Lin HY, Liu KX, Lu B, Lu ZQ, Maegele M, Peng TQ, Shang Y, Su L, Sun BW, Wang CS, Wang J, Wang JH, Wang P, Xie JF, Xie LX, Zhang LN, Zingarelli B, Guan XD, Wu JF, Yao YM; Shock and Sepsis Society of Chinese Research Hospital Association; China Critical Care Immunotherapy Research Group; International Federation of the Shock Societies (IFSS). Expert consensus on the monitoring and treatment of sepsis-induced immunosuppression. Mil Med Res. 2022 Dec 26;9(1):74. doi: 10.1186/s40779-022-00430-y. |
| D015229 |
| Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D012141 | Respiratory Tract Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |