SepsisNCT06491966
Clinical Outcomes and Inflammatory Responses in Viral vs. Bacterial Sepsis
An observational study of Sepsis and Sepsis Bacterial, run by Sichuan Provincial People's Hospital at 1 site in China.
Trial summary
This observational cohort study aims to compare clinical outcomes and inflammatory responses between patients with viral sepsis, specifically COVID-19-associated sepsis, and those with bacterial sepsis. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Sepsis, Sepsis Bacterial, Viral Sepsis
- What is being tested?
- observation
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 2 Apr 2024to 10 Jul 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients admitted to the ICU of Sichuan Provincial People's Hospital from July 2021 to December 2023 diagnosed with sepsis according to Sepsis 3.0 criteria.
Who may be able to join
- Patients diagnosed with sepsis according to Sepsis 3.0 criteria.
- Patients with confirmed bacterial sepsis based on positive bacterial cultures.
- Patients with confirmed viral sepsis, specifically COVID-19, diagnosed via RT-PCR for SARS-CoV-2 for viral group and negative for bacterial group.
- Patients aged 18 years and older.
- Patients admitted to the ICU during the study period.
Who cannot join
- Patients with mixed bacterial and viral infections.
- Patients with sepsis not meeting the Sepsis 3.0 criteria.
- Patients who received immunomodulatory therapies other than standard treatments (e.g., investigational drugs).
- Pregnant or breastfeeding women.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Sichuan Provincial People's Hospital
Chengdu, Sichuan, 610091
Lin Chen, +8618111585286, chenlinhx@med.uestc.edu.cn
Da Jing, +8613547136509, jingda1989@163.com
About this study
Official title: Comparative Analysis of Clinical Outcomes and Inflammatory Responses in Viral Versus Bacterial Sepsis: A Retrospective Cohort Study in ICU Patients
This observational cohort study aims to compare clinical outcomes and inflammatory responses between patients with viral sepsis, specifically COVID-19-associated sepsis, and those with bacterial sepsis. Conducted at Sichuan Provincial People's Hospital, the study will retrospectively analyze data from ICU patients admitted between July 2021 and December 2023. The primary objective is to identify reliable biomarkers and diagnostic methods to improve patient outcomes through personalized diagnostic and therapeutic strategies.
Read the detailed description
Sepsis, a major cause of morbidity and mortality in ICU patients, has garnered increased attention during the COVID-19 pandemic due to the high mortality rates associated with viral sepsis. This study seeks to elucidate the differences in clinical outcomes, inflammatory responses, and treatment strategies between bacterial and viral sepsis. By leveraging a comprehensive dataset of ICU patients diagnosed with sepsis at Sichuan Provincial People's Hospital, the study will retrospectively compare the two sepsis types.
A total of 267 patients diagnosed according to Sepsis 3.0 criteria, including 105 with bacterial sepsis and 162 with viral sepsis (COVID-19 confirmed via RT-PCR), will be included. Key clinical parameters such as mortality rate, length of ICU stay, SOFA scores, and the need for life support measures (mechanical ventilation, CRRT, ECMO) will be analyzed. Additionally, the study will examine cytokine profiles and other inflammatory markers to identify significant differences between the two groups.
The study will utilize advanced statistical methods, including Kaplan-Meier survival analysis, multinomial logistic regression, and ROC curve analysis, to evaluate the predictive power of various biomarkers. The findings are expected to highlight critical factors contributing to the higher mortality observed in viral sepsis and inform the development of targeted treatment strategies. The ultimate goal is to improve diagnostic accuracy and patient outcomes through personalized approaches tailored to the type of sepsis.
Key objectives include understanding the distinct inflammatory responses in bacterial and viral sepsis and identifying reliable biomarkers for differentiation. The study will also evaluate the impact of different treatment regimens, particularly antibiotic use, on clinical outcomes. Insights gained from this research will contribute to the broader understanding of sepsis management and guide future clinical practice and research.
- Conditions
- Sepsis, Sepsis Bacterial, Viral Sepsis, Inflammatory Response, Cytokine Storm, COVID-19
- Being tested
- observation
- Medical subject headings
- Sepsis, Viremia, Cytokine Release Syndrome, COVID-19, Multiple Organ Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
observationOther
data collected includes demographic information, clinical outcomes (mortality rate, ICU stay length), inflammatory markers (e.g., IL-2, IL-10, TNF-α), and treatment details (mechanical ventilation, CRRT, ECMO, antibiotics). Culture results, NGS findings, and imaging reports were also documented.
| Study group | Role | What they receive |
|---|---|---|
| viral sepsis group | The viral sepsis group comprises patients with sepsis secondary to viral infections, specifically COVID-19. Patients in this group were admitted to the ICU of Sichuan Provincial People's Hospital between July 2021 and December 2023 and diagnosed with viral sepsis based on positive RT-PCR results for SARS-CoV-2. Receives: Other: observation | |
| bacterial sepsis group | The bacterial sepsis group includes patients with sepsis resulting from bacterial infections. These patients were admitted to the ICU of Sichuan Provincial People's Hospital during the same period and diagnosed with bacterial sepsis based on positive bacterial cultures. Receives: Other: observation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality rate
The primary outcome measure is the mortality rate of patients diagnosed with sepsis. This measure will compare the 28-day survival rate in the ICU between patients with bacterial sepsis and those with viral sepsis, specifically COVID-19-associated sepsis.
Measured: 28 days
Length of ICU stay
This outcome measure will assess the length of ICU stay for patients diagnosed with sepsis. The comparison will be made between bacterial sepsis and viral sepsis patients, considering the duration of ICU admission from the time of diagnosis until discharge or death.
Measured: From ICU admission until discharge or death, assessed up to 28 days
Secondary outcomes (2)
Levels of key inflammatory markers
This outcome measure will assess the levels of key inflammatory markers, including IL-2, IL-6, IL-8, IL-10, TNF-α, MYD88, mCD64, and nCD64. The comparison will be made between bacterial and viral sepsis patients to identify significant differences in cytokine profiles and their impact on sepsis outcomes.
Measured: baseline (Measured at the time of ICU admission)
Incidence of secondary infections
This outcome measure will evaluate the incidence of secondary infections in patients diagnosed with sepsis. The focus will be on identifying the occurrence of secondary bacterial or fungal infections in both bacterial and viral sepsis groups, as well as the impact of these infections on patient outcomes.
Measured: Assessed from the time of ICU admission up to 28 days or until discharge or death, whichever came first
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2024
- Study start2 Apr 2024
- Primary completion7 Jul 2024 (estimated)
- Study completion10 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SepsisStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sichuan Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lin Chen, Sichuan Provincial People's Hospital
- Investigators
- Lin Chen, doctor, Principal investigator, Sichuan Provincial People's Hospita
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06491966
- Sponsor's protocol ID
- SichuanPPHLC03
- Status last verified
- Jul 2024
- First submitted
- 1 Jul 2024
- Last updated
- 9 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: At this stage, the decision on whether to make individual participant data (IPD) available to other researchers has not been finalized. Considerations include ethical and privacy concerns, institutional policies, and the potential benefit to the scientific community. If data sharing is implemented in the future, it will comply with relevant regulations and guidelines, ensuring the privacy and confidentiality of the participants. Researchers interested in accessing the IPD may contact the principal investigator for further information and potential collaboration opportunities.
Publications
Xiong L, Tang H, Xie Q, Fang H, Jing D, Chen L. Immune Signatures Distinguish Pure and Mixed Sepsis in Critical COVID-19: A Retrospective Cohort Study. J Inflamm Res. 2025 Aug 14;18:11139-11153. doi: 10.2147/JIR.S531962. eCollection 2025.
PubMed 40831520
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Analysis of Clinical Outcomes and Inflammatory Responses in Viral Versus Bacterial Sepsis: A Retrospective Cohort Study in ICU Patients
- ClinicalTrials.gov ID
- NCT06491966
- Acronym / sponsor ID
- SichuanPPHLC03
- Conditions
- Sepsis, Sepsis Bacterial, Viral Sepsis, Inflammatory Response, Cytokine Storm, COVID-19
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Sichuan Provincial People's HospitalUniversity, hospital or other
- Study start
- 2 Apr 2024 (actual)
- Primary completion
- 7 Jul 2024 (estimated)
- Study completion
- 10 Jul 2024 (estimated)
- First posted
- 9 Jul 2024 (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 observational cohort study aims to compare clinical outcomes and inflammatory responses between patients with viral sepsis, specifically COVID-19-associated sepsis, and those with bacterial sepsis. Conducted at Sichuan Provincial People's Hospital, the study will retrospectively analyze data from ICU patients admitted between July 2021 and December 2023. The primary objective is to identify reliable biomarkers and diagnostic methods to improve patient outcomes through personalized diagnostic and therapeutic strategies.
Detailed description
Sepsis, a major cause of morbidity and mortality in ICU patients, has garnered increased attention during the COVID-19 pandemic due to the high mortality rates associated with viral sepsis. This study seeks to elucidate the differences in clinical outcomes, inflammatory responses, and treatment strategies between bacterial and viral sepsis. By leveraging a comprehensive dataset of ICU patients diagnosed with sepsis at Sichuan Provincial People's Hospital, the study will retrospectively compare the two sepsis types.
A total of 267 patients diagnosed according to Sepsis 3.0 criteria, including 105 with bacterial sepsis and 162 with viral sepsis (COVID-19 confirmed via RT-PCR), will be included. Key clinical parameters such as mortality rate, length of ICU stay, SOFA scores, and the need for life support measures (mechanical ventilation, CRRT, ECMO) will be analyzed. Additionally, the study will examine cytokine profiles and other inflammatory markers to identify significant differences between the two groups.
The study will utilize advanced statistical methods, including Kaplan-Meier survival analysis, multinomial logistic regression, and ROC curve analysis, to evaluate the predictive power of various biomarkers. The findings are expected to highlight critical factors contributing to the higher mortality observed in viral sepsis and inform the development of targeted treatment strategies. The ultimate goal is to improve diagnostic accuracy and patient outcomes through personalized approaches tailored to the type of sepsis.
Key objectives include understanding the distinct inflammatory responses in bacterial and viral sepsis and identifying reliable biomarkers for differentiation. The study will also evaluate the impact of different treatment regimens, particularly antibiotic use, on clinical outcomes. Insights gained from this research will contribute to the broader understanding of sepsis management and guide future clinical practice and research.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| viral sepsis group | – | Other: observationThe viral sepsis group comprises patients with sepsis secondary to viral infections, specifically COVID-19. Patients in this group were admitted to the ICU of Sichuan Provincial People's Hospital between July 2021 and December 2023 and diagnosed with viral sepsis based on positive RT-PCR results for SARS-CoV-2. |
| bacterial sepsis group | – | Other: observationThe bacterial sepsis group includes patients with sepsis resulting from bacterial infections. These patients were admitted to the ICU of Sichuan Provincial People's Hospital during the same period and diagnosed with bacterial sepsis based on positive bacterial cultures. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted to the ICU of Sichuan Provincial People's Hospital from July 2021 to December 2023 diagnosed with sepsis according to Sepsis 3.0 criteria.
Key inclusion criteria (5 listed)
- Patients diagnosed with sepsis according to Sepsis 3.0 criteria.
- Patients with confirmed bacterial sepsis based on positive bacterial cultures.
- Patients with confirmed viral sepsis, specifically COVID-19, diagnosed via RT-PCR for SARS-CoV-2 for viral group and negative for bacterial group.
- Patients aged 18 years and older.
- Patients admitted to the ICU during the study period.
Key exclusion criteria (4 listed)
- Patients with mixed bacterial and viral infections.
- Patients with sepsis not meeting the Sepsis 3.0 criteria.
- Patients who received immunomodulatory therapies other than standard treatments (e.g., investigational drugs).
- Pregnant or breastfeeding women.
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 |
|---|---|---|
| observationdata collected includes demographic information, clinical outcomes (mortality rate, ICU stay length), inflammatory markers (e.g., IL-2, IL-10, TNF-α), and treatment details (mechanical ventilation, CRRT, ECMO, antibiotics). Culture results, NGS findings, and imaging reports were also documented. | Other | bacterial sepsis group, viral sepsis group |
Primary outcome
Mortality rate
Time frame: 28 days
The primary outcome measure is the mortality rate of patients diagnosed with sepsis. This measure will compare the 28-day survival rate in the ICU between patients with bacterial sepsis and those with viral sepsis, specifically COVID-19-associated sepsis.
Length of ICU stay
Time frame: From ICU admission until discharge or death, assessed up to 28 days
This outcome measure will assess the length of ICU stay for patients diagnosed with sepsis. The comparison will be made between bacterial sepsis and viral sepsis patients, considering the duration of ICU admission from the time of diagnosis until discharge or death.
2 secondary outcomes
Levels of key inflammatory markers
Time frame: baseline (Measured at the time of ICU admission)
Incidence of secondary infections
Time frame: Assessed from the time of ICU admission up to 28 days or until discharge or death, whichever came first
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2024.
- Derived from this study: PubMed 40831520Xiong L, Tang H, Xie Q, Fang H, Jing D, Chen L. Immune Signatures Distinguish Pure and Mixed Sepsis in Critical COVID-19: A Retrospective Cohort Study. J Inflamm Res. 2025 Aug 14;18:11139-11153. doi: 10.2147/JIR.S531962. eCollection 2025.
- Individual participant dataSharing planned: Undecided. At this stage, the decision on whether to make individual participant data (IPD) available to other researchers has not been finalized. Considerations include ethical and privacy concerns, institutional policies, and the potential benefit to the scientific community. If data sharing is implemented in the future, it will comply with relevant regulations and guidelines, ensuring the privacy and confidentiality of the participants. Researchers interested in accessing the IPD may contact the principal investigator for further information and potential collaboration opportunities.
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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. This study is not recruiting at the moment.
Lin Chen, doctor principal investigator
Sichuan Provincial People's Hospita
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 Sepsis and Sepsis Bacterial, run by Sichuan Provincial 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 5 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 9 Jul 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lin Chen, doctor (8618111585286, chenlinhx@med.uestc.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality rate (time frame: 28 days). The study lists 2 primary outcomes in all. 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 NCT06491966, which also lists 1 linked publication.
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 9 Jul 2024.