Metagenomic Next-Generation Sequencing Guides Anti-Infection Strategies

ConditionsAIDS Pneumonia Sepsis, Neonatal

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18-65

SponsorGuangzhou 8th People's Hospital

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

The criteria for severe pneumonia diagnosis refer to the 2021 ATS (American Thoracic Society) and IDSA (Infectious Diseases Society of America) guidelines for the treatment of community-acquired pneumonia;

Disqualifiers

Coexisting central nervous system lesions, severe liver disease, or cirrhosis;

Concurrent AIDS-related or unrelated tumors;

Women who are pregnant or breastfeeding;

Severe underlying diseases of the heart, lungs, liver, kidneys, etc.;

Trial population

All study participants come from the OSPWH (Patients With HIV/AIDS) cohort at the Guangzhou Eighth People's Hospital.

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

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

Treatment groups

400 Participants

are divided into 2 treatment groups

Group A: Pathogen metagenomic next-generation sequencing group1 intervention

Group B: Conventional pathogen detection group0 interventions

Trial outcomes

Primary outcomes

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.

Time frame

4 weeks

Secondary outcomes

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.

Time frame

4 weeks

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Guangzhou 8th People's Hospital

Lead sponsor

Source ClinicalTrials.gov

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