AIDSNCT06145841
Metagenomic Next-Generation Sequencing Guides Anti-Infection Strategies
An observational study of AIDS and Pneumonia, run by Guangzhou 8th People's Hospital at 1 site in China.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- AIDS, Pneumonia, Sepsis, Neonatal
- What is being tested?
- Pathogen metagenomic next-generation sequencing
- How many people
- 400 participants
- Where
- 1 siteChina
- Study dates
- 23 Oct 2023to 23 Oct 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All study participants come from the OSPWH (Patients With HIV/AIDS) cohort at the Guangzhou Eighth People's Hospital.
Who may be able to join
- 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:
- 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;
- 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).
Who cannot join
- 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.;
- Alcohol abuse or drug use;
- The researcher believes that the overall condition of the subject affects the evaluation and completion of the trial.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Linghua Li
Guangzhou, Guangdong, 510060
Linghua Li, PhD, +862083710825, llheliza@126.com
Yaozu He, MD, +862083710825, hyzdyl99@163.com
About this study
Official title: Clinical Application of Metagenomic Next-Generation Sequencing-Guided Anti-Infection Strategies in AIDS Patients With Severe Pneumonia and/or Sepsis
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
Read the detailed description
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.
- Conditions
- AIDS, Pneumonia, Sepsis, Neonatal
- Being tested
- Pathogen metagenomic next-generation sequencing
- Keywords
- AIDS, severe pneumonia, Sepsis, metagenomic next-generation sequencing
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Pneumonia, Neonatal Sepsis, Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pathogen metagenomic next-generation sequencingDiagnostic test
In diagnosing patients with AIDS combined with severe pneumonia and/or sepsis, use pathogen metagenomics technology to detect peripheral blood specimens
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Pathogen metagenomic next-generation sequencing | |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 weeks
Secondary outcomes (1)
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.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2023
- Study start23 Oct 2023
- Primary completion23 Oct 2026 (estimated)
- Study completion23 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for AIDSStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangzhou 8th People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Linghua LI, Guangzhou 8th People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06145841
- Sponsor's protocol ID
- GZ8H-202322259s
- Status last verified
- Nov 2023
- First submitted
- 17 Nov 2023
- Last updated
- 24 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32016535Besser 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.
PubMed 29074157Pei 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.
PubMed 36567402
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Application of Metagenomic Next-Generation Sequencing-Guided Anti-Infection Strategies in AIDS Patients With Severe Pneumonia and/or Sepsis
- ClinicalTrials.gov ID
- NCT06145841
- Acronym / sponsor ID
- GZ8H-202322259s
- Conditions
- AIDS, Pneumonia, Sepsis, Neonatal
- Keywords
- AIDS, severe pneumonia, Sepsis, metagenomic next-generation sequencing
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Guangzhou 8th People's HospitalUniversity, hospital or other
- Study start
- 23 Oct 2023 (actual)
- Primary completion
- 23 Oct 2026 (estimated)
- Study completion
- 23 Oct 2027 (estimated)
- First posted
- 24 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pathogen metagenomic next-generation sequencing group | – | Diagnostic Test: Pathogen metagenomic next-generation sequencingThis 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. |
| 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All study participants come from the OSPWH (Patients With HIV/AIDS) cohort at the Guangzhou Eighth People's Hospital.
Key inclusion criteria (6 listed)
- 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:
Key exclusion criteria (6 listed)
- 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.;
- Alcohol abuse or drug use;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pathogen metagenomic next-generation sequencingIn diagnosing patients with AIDS combined with severe pneumonia and/or sepsis, use pathogen metagenomics technology to detect peripheral blood specimens | Diagnostic test | Pathogen metagenomic next-generation sequencing group |
Primary outcome
Pathogen detection rate and clinical diagnosis concordance rate
Time frame: 4 weeks
Analyze the concordance rate between the pathogen spectrum detected using pathogen metagenomics technology and the final clinical disease diagnosis.
1 secondary outcome
Clinical treatment efficacy rate
Time frame: 4 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2023.
- Results publication: PubMed 32016535Barbier 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.
- Results publication: PubMed 29074157Besser 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.
- Results publication: PubMed 36567402Pei 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of AIDS and Pneumonia, run by Guangzhou 8th People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathogen detection rate and clinical diagnosis concordance rate (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06145841, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2023.