Using advanced sequencing to guide infection treatment in AIDS patients
Official title: Clinical Application of Metagenomic Next-Generation Sequencing-Guided Anti-Infection Strategies in AIDS Patients With Severe Pneumonia and/or Sepsis
Run by Guangzhou 8th People's Hospital · NCT06145841 · Data updated 2026-11-12
This study is testing if a new DNA sequencing method can help doctors choose better infection treatments for AIDS patients with severe pneumonia or sepsis compared to standard methods.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 65 Years |
| Sex | All |
| Enrollment | 400 (estimated) |
| Sponsor | Guangzhou 8th People's Hospital Academic / other |
| Locations | 1 site (Guangzhou, Guangdong) |
| Status | Recruiting |
| Started | October 23, 2023 |
| Main results expected | October 23, 2026 |
| Study ends | October 23, 2027 |
| Registry record updated | November 24, 2023 |
| Trial ID | NCT06145841 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include adults aged 18 to 65 with confirmed HIV infection who have progressed to AIDS and are diagnosed with severe pneumonia or septic shock.
✕Probably not a fit
Patients with severe underlying diseases, central nervous system lesions, or those who are pregnant or breastfeeding may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to evaluate the effectiveness of metagenomic next-generation sequencing technology in guiding anti-infection treatments for AIDS patients suffering from severe pneumonia and/or sepsis. Participants will be divided into two groups: one receiving treatment guided by metagenomic sequencing and the other following conventional pathogen detection methods. The study will compare pathogen detection rates and the accuracy of clinical diagnoses between these groups, utilizing blood samples for analysis. The goal is to determine if metagenomic sequencing can improve clinical outcomes in this vulnerable population.
Why it matters
Potential benefit: If successful, this approach could lead to more accurate and effective treatment strategies for AIDS patients with severe infections.
How similar studies have gone: While the use of metagenomic sequencing in clinical settings is emerging, this specific application in guiding treatment for AIDS-related infections is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Confirmed HIV infection; 2. Progression to AIDS stage: CD4+ count \<200 cells/ul and/or occurrence of AIDS opportunistic infections; 3. Age between 18 and 65 years; 4. Meeting the diagnosis of severe pneumonia or septic shock: 1. 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; 2. The criteria for septic shock refer to the Chinese Society of Critical Care Medicine's "Chinese Guidelines for the Emergency Treatment of Sepsis/Septic Shock (2018). Exclusion Criteria: 1. Coexisting central nervous system lesions, severe liver disease, or cirrhosis; 2. Concurrent AIDS-related or unrelated tumors; 3. Women who are pregnant or breastfeeding; 4. Severe underlying diseases of the heart, lungs, liver, kidneys, etc.; 5. Alcohol abuse or drug use; 6. The researcher believes that the overall condition of the subject affects the evaluation and completion of the trial.
Where it's running
-
Linghua Li
Guangzhou, Guangdong, China Recruiting
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.