SepsisNCT05143736
Nasal and Gut Microbiota Combined Clinical Events Predicts the Prognosis of Septic Patients
An observational study of Sepsis and Septic Shock, run by Zhujiang Hospital at 2 sites in China.
Trial summary
In this prospective, multicentered , diagnostic trial, nasal and fecal specimens will collected from patients with sepsis in two critical care units(ICU) at the enrollment day ,the third, seventh, and fourteen days after enrollment or until ICU discharge (whatever come first). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Sepsis, Septic Shock
- What is being tested?
- gut and nasal microbiota detection
- How many people
- 300 participants
- Where
- 2 sitesChina
- Study dates
- 10 Jan 2022to 31 Jan 2025
- 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 80 years
- All sexes
- Adult, Older adult
Study population: In this study, patients who met the Sepsis 3.0 diagnostic criteria and with PCT ≥ 2ng/ml and will be recruited.
Who may be able to join
- Meet the 2016 International Sepsis Guidelines diagnostic criteria (sepsis 3.0).
- Serum procalcitonin≥ 2 ng/mL at enrollment.
Who cannot join
- Patients will be excluded if participants meet any of the following criteria:
- age<18 years old or > 80 years
- pregnancy or lactation
- solid organ or bone marrow transplant
- advanced pulmonary fibrosis
- HIV-positive
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- neutropenia;
- hematological/lymphatic tumors have no remission;
- limited care (lack of commitment to full and aggressive support);
- long-term use of immunosuppressive drugs or immunodeficiency;
- advanced tumors;
- combined with noninfectious factors leading to death (uncontrolled large bleeding, cerebral hernia, etc.);
- Combined with autoimmune diseases
- Paraquat poisoning
- Combined with Nasopharyngeal carcinoma
- Combined with chronic nasosinusitis
- Combined with severe nasal injuries
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
Department of Critical Care Medicine of Dongguan People's Hospital, Dongguan
Dongguan, Guangdong
Yuping Liao, MD, +86-13650171253, yupliao@163.com
- Recruiting
Department of Critical Care Medicine of Zhujiang Hospital
Guanzhou, Guangdong
zhanguo Liu, M.D.PhD, +862062782927, zhguoliu@163.com
About this study
Official title: Nasal and Gut Microbiota Combined Clinical Events Predicts the Prognosis of Patients With Sepsis: a Prospective, Multicentered, Diagnostic Trial
In this prospective, multicentered , diagnostic trial, nasal and fecal specimens will collected from patients with sepsis in two critical care units(ICU) at the enrollment day ,the third, seventh, and fourteen days after enrollment or until ICU discharge (whatever come first). Total DNA from the nasal and fecal specimens will be extracted, amplified, and sequenced to determined the characteristics of gut microbiota and nasal microbiota. Finally, the characteristics of gut microbiota and nasal microbiota combined clinical information will be used to construct a prediction model to predict the prognosis of sepsis.
Read the detailed description
Background:
Sepsis should be defined as life-threatening organ dysfunction caused by a dysregulated host response to infection, with high morbidity and mortality, and its total mortality is 10% to 52%. In sepsis, it is not clear sufficiently about the relationship between intestinal and nasal microbiota character and the development of the sepsis.The study aim to construct a prediction model to predict the prognosis and development of sepsis.
Purpose:
- To construct a prediction model using nasal and gut microbiota combined with clinical events to predict the prognosis of patients with sepsis and development of sepsis.
- Analyze the characteristics of nasal and gut microbiota in patients with sepsis using microbiology.
Methods:
nasal and fecal specimens will collected from patients with sepsis in two critical care units(ICU) at the enrollment day ,the third, seventh, and fourteen days after enrollment or until ICU discharge (whatever come first). Total DNA from the nasal and fecal specimens will be extracted, amplified, and sequenced to determined the characteristics of gut microbiota and nasal microbiota. Meanwhile, some related clinical information also will be collected,including demographic characteristics, comorbidities, infection site, results of the microbiology experiments, vital signs, invasive tubing indwelling at enrollment，combined medication，the requirement of organ function support, laboratory indexing, sequential organ failure assessment score and Acute Physiology and Chronic Health Evaluation score. Finally, the characteristics of gut microbiota and nasal microbiota combined the clinical information will be used to construct a prediction model to predict the prognosis of sepsis. The primary outcome is the 28-day all-cause mortality. The secondary outcomes are the incidence of septic shock, the incidence of persistent inflammation- immunosuppression catabolism syndrome and the 90-day all-cause mortality.
- Conditions
- Sepsis, Septic Shock
- Being tested
- gut and nasal microbiota detection
- Keywords
- Sepsis, Septic Shock, nasal microbiota, gut microbiota
- Medical subject headings
- Sepsis, Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gut and nasal microbiota detectionDiagnostic test
The nasal and fecal specimens will be collected by swabs from subjects with sepsis. After that, total DNA of nasal and gut microbiota will be extracted , amplified, and sequenced to determine the gut and nasal microbiota.
| Study group | Role | What they receive |
|---|---|---|
| Modeling cohort | The population enrolled at the intensive care unit of Zhujiang Hospital of Southern Medical University in Guangdong Province, China will be used as a modeling cohort.For the patients in this cohort, the nasal and fecal specimens and related clinical information will collected to construct the prediction model. Receives: Diagnostic Test: gut and nasal microbiota detection | |
| validation cohort | The population enrolled at the intensive care unit of Dongguan People's Hospital in Guangdong Province, China will be used as a validation cohort. Receives: Diagnostic Test: gut and nasal microbiota detection |
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause death at 28 days
All-cause mortality from the enrollment to the 28th day
Measured: The outcome will be assessed on the 28th day from enrollment
Secondary outcomes (2)
Incidence of septic shock
Incidence of septic shock during the ICU stay.
Measured: The outcome will be assessed diurnally until ICU discharge，the longest evaluation duration is no more than 28 days
Incidence of persistent inflammation-immunosuppression catabolism syndrome (PICS)
The incidence of PICS during the ICU stay. Patients who meet all the following diagnostic criteria will be diagnosed PICS: 1) the duration of ICU stay more than 14 days, 2) the level of serum C reactive protein > 50ug/dL, 3) Lymphocyte counts<0.80*10^9/L,4) serum albumin<3g/dL, 5) serum prealbumin<10mg/dL, 6) The creatinine height index<80%. 7)weight loss more than 18% or BMI<18
Measured: The outcome will be assessed diurnally until ICU discharge，the longest evaluation duration is no more than 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2021
- Study start10 Jan 2022
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Jan 2025 (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.
- More trials run by Zhujiang HospitalThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhujiang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Liu Zhanguo, Zhujiang Hospital
- Investigators
- Zhanguo Liu, M.D.PhD, Principal investigator, Department of Critical Care Medicine of Zhujiang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05143736
- Sponsor's protocol ID
- 2021-KY-108-01
- Status last verified
- Jan 2024
- First submitted
- 16 Oct 2021
- Last updated
- 19 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The datasets generated and analyzed during the study are available from the corresponding author on reasonable request.
Publications
Tan XL, Liu HY, Long J, Jiang Z, Luo Y, Zhao X, Cai S, Zhong X, Cen Z, Su J, Zhou H. Septic patients in the intensive care unit present different nasal microbiotas. Future Microbiol. 2019 Mar;14(5):383-395. doi: 10.2217/fmb-2018-0349. Epub 2019 Feb 26.
PubMed 30803270
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nasal and Gut Microbiota Combined Clinical Events Predicts the Prognosis of Patients With Sepsis: a Prospective, Multicentered, Diagnostic Trial
- ClinicalTrials.gov ID
- NCT05143736
- Acronym / sponsor ID
- 2021-KY-108-01
- Conditions
- Sepsis, Septic Shock
- Keywords
- Sepsis, Septic Shock, nasal microbiota, gut microbiota
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Zhujiang HospitalUniversity, hospital or other
- Study start
- 10 Jan 2022 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Jan 2025 (estimated)
- First posted
- 3 Dec 2021 (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.
In this prospective, multicentered , diagnostic trial, nasal and fecal specimens will collected from patients with sepsis in two critical care units(ICU) at the enrollment day ,the third, seventh, and fourteen days after enrollment or until ICU discharge (whatever come first). Total DNA from the nasal and fecal specimens will be extracted, amplified, and sequenced to determined the characteristics of gut microbiota and nasal microbiota. Finally, the characteristics of gut microbiota and nasal microbiota combined clinical information will be used to construct a prediction model to predict the prognosis of sepsis.
Detailed description
Background:
Sepsis should be defined as life-threatening organ dysfunction caused by a dysregulated host response to infection, with high morbidity and mortality, and its total mortality is 10% to 52%. In sepsis, it is not clear sufficiently about the relationship between intestinal and nasal microbiota character and the development of the sepsis.The study aim to construct a prediction model to predict the prognosis and development of sepsis.
Purpose:
- To construct a prediction model using nasal and gut microbiota combined with clinical events to predict the prognosis of patients with sepsis and development of sepsis.
- Analyze the characteristics of nasal and gut microbiota in patients with sepsis using microbiology.
Methods:
nasal and fecal specimens will collected from patients with sepsis in two critical care units(ICU) at the enrollment day ,the third, seventh, and fourteen days after enrollment or until ICU discharge (whatever come first). Total DNA from the nasal and fecal specimens will be extracted, amplified, and sequenced to determined the characteristics of gut microbiota and nasal microbiota. Meanwhile, some related clinical information also will be collected,including demographic characteristics, comorbidities, infection site, results of the microbiology experiments, vital signs, invasive tubing indwelling at enrollment，combined medication，the requirement of organ function support, laboratory indexing, sequential organ failure assessment score and Acute Physiology and Chronic Health Evaluation score. Finally, the characteristics of gut microbiota and nasal microbiota combined the clinical information will be used to construct a prediction model to predict the prognosis of sepsis. The primary outcome is the 28-day all-cause mortality. The secondary outcomes are the incidence of septic shock, the incidence of persistent inflammation- immunosuppression catabolism syndrome and the 90-day all-cause mortality.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Modeling cohort | – | Diagnostic Test: gut and nasal microbiota detectionThe population enrolled at the intensive care unit of Zhujiang Hospital of Southern Medical University in Guangdong Province, China will be used as a modeling cohort.For the patients in this cohort, the nasal and fecal specimens and related clinical information will collected to construct the prediction model. |
| validation cohort | – | Diagnostic Test: gut and nasal microbiota detectionThe population enrolled at the intensive care unit of Dongguan People's Hospital in Guangdong Province, China will be used as a validation cohort. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- In this study, patients who met the Sepsis 3.0 diagnostic criteria and with PCT ≥ 2ng/ml and will be recruited.
Key inclusion criteria (2 listed)
- Meet the 2016 International Sepsis Guidelines diagnostic criteria (sepsis 3.0).
- Serum procalcitonin≥ 2 ng/mL at enrollment.
Key exclusion criteria (17 listed)
- age<18 years old or > 80 years
- pregnancy or lactation
- solid organ or bone marrow transplant
- advanced pulmonary fibrosis
- HIV-positive
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 |
|---|---|---|
| gut and nasal microbiota detectionThe nasal and fecal specimens will be collected by swabs from subjects with sepsis. After that, total DNA of nasal and gut microbiota will be extracted , amplified, and sequenced to determine the gut and nasal microbiota. | Diagnostic test | Modeling cohort, validation cohort |
Primary outcome
All-cause death at 28 days
Time frame: The outcome will be assessed on the 28th day from enrollment
All-cause mortality from the enrollment to the 28th day
2 secondary outcomes
Incidence of septic shock
Time frame: The outcome will be assessed diurnally until ICU discharge，the longest evaluation duration is no more than 28 days
Incidence of persistent inflammation-immunosuppression catabolism syndrome (PICS)
Time frame: The outcome will be assessed diurnally until ICU discharge，the longest evaluation duration is no more than 28 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2024.
- Background: PubMed 30803270Tan XL, Liu HY, Long J, Jiang Z, Luo Y, Zhao X, Cai S, Zhong X, Cen Z, Su J, Zhou H. Septic patients in the intensive care unit present different nasal microbiotas. Future Microbiol. 2019 Mar;14(5):383-395. doi: 10.2217/fmb-2018-0349. Epub 2019 Feb 26.
- Individual participant dataSharing planned: Undecided. The datasets generated and analyzed during the study are available from the corresponding author on reasonable request.
Related trials for Sepsis
Not yet recruitingPhase 2/3
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
Active, not recruiting
CT for Personalized Mechanical Ventilation
Ventilator-Induced Lung Injury, Sepsis Syndrome
RecruitingPhase 4
A Study to Compare the Efficacy and Safety of Extended and Intermittent Infusion of Beta-lactams in Critically Ill Paediatric Patients
Infection, Sepsis
Not yet recruiting
Double Plasma Separation and Adsorption in Acute-on-Chronic Liver Failure (DPMAS-ACLF Trial)
Acute-on-Chronic Liver Failure (ACLF)
Active, not recruitingPhase 4
Thymosin Alpha 1 and IgM Levels in Sepsis
Sepsis, Septic Shock
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.
Zhanguo Liu, M.D.PhD principal investigator
Department of Critical Care Medicine of Zhujiang Hospital
2 sites 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 Septic Shock, run by Zhujiang Hospital at 2 sites 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 2 inclusion and 17 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 19 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Zhanguo Liu, M.D.PhD (+86-2062782927, zhguoliu@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All-cause death at 28 days (time frame: The outcome will be assessed on the 28th day from enrollment). 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 NCT05143736, 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 19 Mar 2024.