SepsisNCT06028178
Droplet Digital PCR Combines With Transcriptome Analysis in Early Warning of Sepsis in the Emergency Department
An observational study of Sepsis and Emergent Infections, Treatment, run by Shanghai East Hospital.
Trial summary
Rapid identification of pathogens and early warning of host response are key to improve the prognosis of sepsis. Establishing a comprehensive identification system based on pathogen identification and host immune status is an effective way to achieve early warning stratification of patients with infections in the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis, Emergent Infections, Treatment
- What is being tested?
- Droplet digital PCR
- How many people
- 360 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2024to 31 Dec 2026
- How long will I take part?
- 90 Days
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Prospective inclusion of patients with suspected sepsis with MSS ≥ 2 in the emergency department of Shanghai East Hospital, Shanghai Pudong New District Zhoupu Hospital, Shanghai Pudong New District Gongli Hospital, Shanghai Pudong Hospital and Shanghai Punan Hospital Hospital, Shanghai Pudong Hospital, Shanghai Pudong New Area Hospital and Shanghai Pudong New Area Punan Hospital. The patients will be randomized by stratified grouping and assigned to two parallel groups in the ratio of 5:1.
Who may be able to join
- age ≥ 18 years, regardless of sex
- MSS≥2 score
- written informed consent obtained
Who cannot join
- Age < 18 years, regardless of sex
- Patient's ICU length of stay <24 hours
- Malignant tumor, HIV patients or any terminal-stage disease
- Known pregnancy or lactation
- Participation in other clinical trials
- Inadequate clinical information or missing experimental data
- No signed informed consent obtained
About this study
Official title: Clinical Evaluation of Droplet Digital Polymerase Chain Reaction in Combination With Transcriptome Analysis in Early Warning of Sepsis in the Emergency Department: A Multicenter Prospective Observational Study
Rapid identification of pathogens and early warning of host response are key to improve the prognosis of sepsis. Establishing a comprehensive identification system based on pathogen identification and host immune status is an effective way to achieve early warning stratification of patients with infections in the emergency department. This prospective multicenter clinical study will combine droplet digital PCR (ddPCR) and transcriptomic molecular target assay for validation in patients with suspected sepsis in the emergency department. The purpose is to (1) compare the efficacy of ddPCR with blood culture for early diagnosis and prognosis; (2) assess the diagnostic value of transcriptomic molecular targets based on 29 messenger RNA for the presence or absence of infection as well as infectious agents, and to evaluate their efficacy for prognosis; and (3) assess the diagnostic and therapeutic monitoring value of ddPCR combined with transcriptome analysis methods.
Read the detailed description
Rapid identification of pathogens and early warning of host response are key to improve the prognosis of sepsis. Establishing a comprehensive identification system based on pathogen identification and host immune status is an effective way to achieve early warning stratification of patients with infections in the emergency department. Therefore, based on our preliminary single-center study, this prospective multicenter clinical study will combine droplet digital PCR (ddPCR) and transcriptomic molecular target assay for validation in patients with suspected sepsis in the emergency department. The purpose is to (1) compare the efficacy of ddPCR with blood culture for early diagnosis and prognosis; (2) assess the diagnostic value of transcriptomic molecular targets based on 29 messenger RNA for the presence or absence of infection as well as infectious agents, and to evaluate their efficacy for prognosis; and (3) assess the diagnostic and therapeutic monitoring value of ddPCR combined with transcriptome analysis methods. In a word, this study will be undertaken to assess the diagnostic and therapeutic monitoring value of early warning models for sepsis in emergency department and to promote them to improve the identification ability of emergency infections.
- Conditions
- Sepsis, Emergent Infections, Treatment
- Being tested
- Droplet digital PCR
- Keywords
- Droplet digital PCR, Transcriptomic molecular target assay
- Medical subject headings
- Sepsis, Breakthrough Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Droplet digital PCRDiagnostic test
Also called Transcriptomic analysis
Droplet digital PCR has potential in resolving polymicrobial infection because it simultaneously achieves unprecedented high sensitivity , high specificity, and absolute quantification without the need for a standard curve.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | The experimental group will recruit 300 participants undergoing blood culture, droplet digital PCR and transcriptome analysis. Receives: Diagnostic Test: Droplet digital PCR | |
| Control group | The control group will recruit 60 participants undergoing blood culture only. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic efficiency of ddPCR combined with transcriptomic analysis in suspected sepsis
Diagnostic efficiency of ddPCR combined with transcriptomic analysis for suspected sepsis in the emergency medicine
Measured: 7days
Prognostic value of ddPCR combined with transcriptomic analysis in suspected sepsis
Prognostic value of ddPCR combined with transcriptomic analysis for suspected sepsis in the emergency medicine
Measured: 28 days
Secondary outcomes (4)
7-day all-cause mortality rate
Evaluation of combined examination by ddPCR and transcriptomic analysis for the evaluation of the prognosis of the sepsis.
Measured: 7 days
28-day all-cause mortality rate
Evaluation of combined examination by ddPCR and transcriptomic analysis for the evaluation of the prognosis of the sepsis.
Measured: 28 days
90-day all-cause mortality rate
Evaluation of combined examination by ddPCR and transcriptomic analysis for the evaluation of the prognosis of the sepsis.
Measured: 90 days
Antimicrobial Resistance and antibiotic application
Evaluation of combined examination by ddPCR and transcriptomic analysis for the the value of guiding clinical drug therapy.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2023
- Study start1 May 2024 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 360 participants (estimated)
- Target duration
- 90 Days
Sponsor and investigators
- Lead sponsor
- Shanghai East Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06028178
- Sponsor's protocol ID
- emergency medicine 20230824
- Status last verified
- Sep 2023
- First submitted
- 17 Aug 2023
- Last updated
- 17 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All individual participant data that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Droplet Digital Polymerase Chain Reaction in Combination With Transcriptome Analysis in Early Warning of Sepsis in the Emergency Department: A Multicenter Prospective Observational Study
- ClinicalTrials.gov ID
- NCT06028178
- Acronym / sponsor ID
- emergency medicine 20230824
- Conditions
- Sepsis, Emergent Infections, Treatment
- Keywords
- Droplet digital PCR, Transcriptomic molecular target assay
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- Shanghai East HospitalUniversity, hospital or other
- Study start
- 1 May 2024 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 8 Sep 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.
Rapid identification of pathogens and early warning of host response are key to improve the prognosis of sepsis. Establishing a comprehensive identification system based on pathogen identification and host immune status is an effective way to achieve early warning stratification of patients with infections in the emergency department. This prospective multicenter clinical study will combine droplet digital PCR (ddPCR) and transcriptomic molecular target assay for validation in patients with suspected sepsis in the emergency department. The purpose is to (1) compare the efficacy of ddPCR with blood culture for early diagnosis and prognosis; (2) assess the diagnostic value of transcriptomic molecular targets based on 29 messenger RNA for the presence or absence of infection as well as infectious agents, and to evaluate their efficacy for prognosis; and (3) assess the diagnostic and therapeutic monitoring value of ddPCR combined with transcriptome analysis methods.
Detailed description
Rapid identification of pathogens and early warning of host response are key to improve the prognosis of sepsis. Establishing a comprehensive identification system based on pathogen identification and host immune status is an effective way to achieve early warning stratification of patients with infections in the emergency department. Therefore, based on our preliminary single-center study, this prospective multicenter clinical study will combine droplet digital PCR (ddPCR) and transcriptomic molecular target assay for validation in patients with suspected sepsis in the emergency department. The purpose is to (1) compare the efficacy of ddPCR with blood culture for early diagnosis and prognosis; (2) assess the diagnostic value of transcriptomic molecular targets based on 29 messenger RNA for the presence or absence of infection as well as infectious agents, and to evaluate their efficacy for prognosis; and (3) assess the diagnostic and therapeutic monitoring value of ddPCR combined with transcriptome analysis methods. In a word, this study will be undertaken to assess the diagnostic and therapeutic monitoring value of early warning models for sepsis in emergency department and to promote them to improve the identification ability of emergency infections.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 90 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | – | Diagnostic Test: Droplet digital PCRThe experimental group will recruit 300 participants undergoing blood culture, droplet digital PCR and transcriptome analysis. |
| Control group | – | –The control group will recruit 60 participants undergoing blood culture only. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Prospective inclusion of patients with suspected sepsis with MSS ≥ 2 in the emergency department of Shanghai East Hospital, Shanghai Pudong New District Zhoupu Hospital, Shanghai Pudong New District Gongli Hospital, Shanghai Pudong Hospital and Shanghai Punan Hospital Hospital, Shanghai Pudong Hospital, Shanghai Pudong New Area Hospital and Shanghai Pudong New Area Punan Hospital. The patients will be randomized by stratified grouping and assigned to two parallel groups in the ratio of 5:1.
Key inclusion criteria (3 listed)
- age ≥ 18 years, regardless of sex
- MSS≥2 score
- written informed consent obtained
Key exclusion criteria (7 listed)
- Age < 18 years, regardless of sex
- Patient's ICU length of stay <24 hours
- Malignant tumor, HIV patients or any terminal-stage disease
- Known pregnancy or lactation
- Participation in other clinical trials
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 |
|---|---|---|
| Droplet digital PCRAlso: Transcriptomic analysisDroplet digital PCR has potential in resolving polymicrobial infection because it simultaneously achieves unprecedented high sensitivity , high specificity, and absolute quantification without the need for a standard curve. | Diagnostic test | Experimental group |
Primary outcome
Diagnostic efficiency of ddPCR combined with transcriptomic analysis in suspected sepsis
Time frame: 7days
Diagnostic efficiency of ddPCR combined with transcriptomic analysis for suspected sepsis in the emergency medicine
Prognostic value of ddPCR combined with transcriptomic analysis in suspected sepsis
Time frame: 28 days
Prognostic value of ddPCR combined with transcriptomic analysis for suspected sepsis in the emergency medicine
4 secondary outcomes
7-day all-cause mortality rate
Time frame: 7 days
28-day all-cause mortality rate
Time frame: 28 days
90-day all-cause mortality rate
Time frame: 90 days
Antimicrobial Resistance and antibiotic application
Time frame: 7 days
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 17 Apr 2024.
- Individual participant dataSharing planned: Yes. All individual participant data that underlie results in a publication
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis and Emergent Infections, Treatment, run by Shanghai East Hospital.
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 3 inclusion and 7 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: opening soon, as of the sponsor's last update on 17 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic efficiency of ddPCR combined with transcriptomic analysis in suspected sepsis (time frame: 7days). 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?
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 17 Apr 2024.