InfectionsNCT05149547
mNGS Versus Blood Culture in FN
An observational study of Infections and Hematologic Diseases, run by Peking University People's Hospital at 1 site in China.
Trial summary
Blood stream infection (BSI) during febrile neutropenia (FN) is a lethal complication, while confirmed diagnosis via blood culture is usually with low sensitivity and time delay. The new technique of metagenome next generation sequencing (mNGS) has the potential of early and more accurate detection of pathogens. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Infections, Hematologic Diseases, Febrile Neutropenia
- What is being tested?
- blood culture versus mNGS detection
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 15 Oct 2021to 31 Aug 2022
- 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 15 years and older
- All sexes
- Child, Adult, Older adult
Study population: patients with hematologic disease during febrile neutropenia
Who may be able to join
- hematologic disease
- febrile neutropenia
Who cannot join
- refuse to consent
- age<=14
- not caused by infection
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Yuqian Sun
Beijing
YUQIAN SUN, sunyuqian83@hotmail.com
About this study
Official title: The Comparison of mNGS Versus Blood Culture for Early Diagnosis of Blood Stream Infection During the Febrile Neutropenia in Patients With Hematological Disease
Blood stream infection (BSI) during febrile neutropenia (FN) is a lethal complication, while confirmed diagnosis via blood culture is usually with low sensitivity and time delay. The new technique of metagenome next generation sequencing (mNGS) has the potential of early and more accurate detection of pathogens. However, this technique has not been well validated for BSI diagnosis in patients with hematological disease. Therefore, we designed a prospective multicenter study to compare the diagnosis performance in BSI.
- Conditions
- Infections, Hematologic Diseases, Febrile Neutropenia
- Being tested
- blood culture versus mNGS detection
- Medical subject headings
- Infections, Hematologic Diseases, Febrile Neutropenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood culture versus mNGS detectionDiagnostic test
peripheral 4ml for mNGS detection
What is being measured
The primary outcome is the main question the study is designed to answer.
diagnosis performance
the sensitivity and specificity of mNGS
Measured: 14 days after sapmpling
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2021
- Study start15 Oct 2021
- Primary completion31 May 2022 (estimated)
- Study completion31 Aug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfectionsStudies of the same condition, open and under way.
- More trials run by Peking University People's 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
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Peking University First Hospital, Peking University International Hospital, Hebei Yanda Ludaopei Hospital
- Responsible party
- Principal investigator, Xiao-Jun Huang, Peking University People's Hospital
- Investigators
- YUQIAN SUN, MD, Principal investigator, Peiking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05149547
- Sponsor's protocol ID
- mNGS for FN(2021PHB362-001)
- Status last verified
- Nov 2021
- First submitted
- 26 Nov 2021
- Last updated
- 8 Dec 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Comparison of mNGS Versus Blood Culture for Early Diagnosis of Blood Stream Infection During the Febrile Neutropenia in Patients With Hematological Disease
- ClinicalTrials.gov ID
- NCT05149547
- Acronym / sponsor ID
- mNGS for FN(2021PHB362-001)
- Conditions
- Infections, Hematologic Diseases, Febrile Neutropenia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Collaborators
- Peking University First Hospital, Peking University International Hospital, Hebei Yanda Ludaopei Hospital
- Study start
- 15 Oct 2021 (actual)
- Primary completion
- 31 May 2022 (estimated)
- Study completion
- 31 Aug 2022 (estimated)
- First posted
- 8 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.
Blood stream infection (BSI) during febrile neutropenia (FN) is a lethal complication, while confirmed diagnosis via blood culture is usually with low sensitivity and time delay. The new technique of metagenome next generation sequencing (mNGS) has the potential of early and more accurate detection of pathogens. However, this technique has not been well validated for BSI diagnosis in patients with hematological disease. Therefore, we designed a prospective multicenter study to compare the diagnosis performance in BSI.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- patients with hematologic disease during febrile neutropenia
Key inclusion criteria (2 listed)
- hematologic disease
- febrile neutropenia
Key exclusion criteria (3 listed)
- refuse to consent
- age<=14
- not caused by infection
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 |
|---|---|---|
| blood culture versus mNGS detectionperipheral 4ml for mNGS detection | Diagnostic test | – |
Primary outcome
diagnosis performance
Time frame: 14 days after sapmpling
the sensitivity and specificity of mNGS
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2021.
- 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. This study is not recruiting at the moment.
YUQIAN SUN, MD principal investigator
Peiking University People's Hospital
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 Infections and Hematologic Diseases, run by Peking University 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 2 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 8 Dec 2021. 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 Yuqian Sun, MD (861088324577, sunyuqian83@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
diagnosis performance (time frame: 14 days after sapmpling). 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 8 Dec 2021.