mNGSNCT04310657
mNGS Was Applied to the Study of Pathogen Identification, Precision Medication and Efficacy Evaluation of Infected Patients
A study testing mNGS in people with mNGS, run by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine.
Trial summary
1) prospectively collected the patients with the proposed infection, confirmed the infection or excluded the infection through mNGS detection combined with traditional pathogen detection methods and clinical characteristics, compared the detection performance of mNGS and traditional methods, and explored the… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- mNGS
- What is being tested?
- mNGS
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2020to 30 Sep 2023
- Phase
- Interventional
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 to 75 years old
- expected length of stay in ICU was > 24 h
- suspected infected patients (PSI or CPIS, qSOFA or SIRS)
Who cannot join
- Pregnant and lactating women
- Who has not signed the informed consent
- the researchers considered that others were not suitable for the study
About this study
- prospectively collected the patients with the proposed infection, confirmed the infection or excluded the infection through mNGS detection combined with traditional pathogen detection methods and clinical characteristics, compared the detection performance of mNGS and traditional methods, and explored the significance of mNGS microbial map characteristics for the diagnosis/exclusion of infection; 2) real-time dynamic monitoring of the pathogen and microecology of infected patients during the targeted drug use, and evaluation of the efficacy in combination with other indicators; 3) to explore the significance of the number of pathogen sequences before the clinical withdrawal of drugs to the clinical practice.
- Conditions
- mNGS
- Being tested
- mNGS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mNGSDiagnostic test
Metagenomics second generation sequencing technology
| Study group | Role | What they receive |
|---|---|---|
| Precision therapy | Experimental | Not described Receives: Diagnostic Test: mNGS |
| control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
28-day mortality
28-day mortality
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2020
- Study start1 Oct 2020 (estimated)
- Primary completion30 Sep 2023 (estimated)
- Study completion30 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for mNGSStudies of the same condition, open and under way.
- More trials run by Shanghai General Hospital, Shanghai Jiao Tong University School of MedicineThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ruilan Wang, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04310657
- Sponsor's protocol ID
- mNGS
- Status last verified
- Mar 2020
- First submitted
- 13 Mar 2020
- Last updated
- 17 Mar 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- mNGS Was Applied to the Study of Pathogen Identification, Precision Medication and Efficacy Evaluation of Infected Patients
- ClinicalTrials.gov ID
- NCT04310657
- Acronym / sponsor ID
- mNGS
- Conditions
- mNGS
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Shanghai General Hospital, Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- 1 Oct 2020 (estimated)
- Primary completion
- 30 Sep 2023 (estimated)
- Study completion
- 30 Sep 2023 (estimated)
- First posted
- 17 Mar 2020 (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.
- prospectively collected the patients with the proposed infection, confirmed the infection or excluded the infection through mNGS detection combined with traditional pathogen detection methods and clinical characteristics, compared the detection performance of mNGS and traditional methods, and explored the significance of mNGS microbial map characteristics for the diagnosis/exclusion of infection; 2) real-time dynamic monitoring of the pathogen and microecology of infected patients during the targeted drug use, and evaluation of the efficacy in combination with other indicators; 3) to explore the significance of the number of pathogen sequences before the clinical withdrawal of drugs to the clinical practice.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Precision therapy | Experimental | Diagnostic Test: mNGS |
| control | No intervention | – |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 to 75 years old
- expected length of stay in ICU was > 24 h
- suspected infected patients (PSI or CPIS, qSOFA or SIRS)
Key exclusion criteria (3 listed)
- Pregnant and lactating women
- Who has not signed the informed consent
- the researchers considered that others were not suitable for the study
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 |
|---|---|---|
| mNGSMetagenomics second generation sequencing technology | Diagnostic test | Precision therapy |
Primary outcome
28-day mortality
Time frame: 28 days
28-day mortality
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing mNGS in people with mNGS, run by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine.
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 3 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 17 Mar 2020. 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?
Results are not available in the source record.
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?
28-day mortality (time frame: 28 days). 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 Mar 2020.