Infectious DiseaseNCT04320810
Developing Metagenomic Approaches to Identify the Causes of Pediatric Infectious Diseases
An observational study of Infectious Disease, run by Children's Hospital of Fudan University at 1 site in China.
Trial summary
Infectious diseases remain leading causes of mortality and morbidity in children. Rapid and accurate diagnosis of infectious diseases in children is important for developing an effective treatment and management strategy. Read more about this study
- Who is it for?
- Ages Up to 16 years
- Conditions the study is for
- Infectious Disease
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2020to 30 Dec 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 Up to 16 years
- All sexes
- No healthy volunteers
- Child
Study population: This study mainly focus on the pediatric patients who is suspected of infectious disease.
Who may be able to join
- Patients are highly suspected of sepsis；
- Patients are highly suspected of respiratory infections；
- Patients are highly suspected of central nervous system infection；
- Patients are highly suspected of fever of unknown origin
Who cannot join
- Congenital malformations；
- Patients requiring surgical intervention;
- Patients with skin barrier dysfunction
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Children Hospital of Fudan University
Shanghai, Shanghai Municipality, 201102
Wenhao Zhou, Doctor, (+86)021-64931003, zwhchfu@126.com
About this study
Infectious diseases remain leading causes of mortality and morbidity in children. Rapid and accurate diagnosis of infectious diseases in children is important for developing an effective treatment and management strategy. However, the current diagnosis of infectious agents mainly depends on culture and molecular testing. Both of the methods either has long turnaround times or narrow detection range. Metagenome next generation sequencing (mNGS) has been applied to the diagnosis of central nervous system infection, lower respiratory tract infection and sepsis, which showed high positive rate, short turnaround time. However, there is currently no assessment of the diagnostic efficacy of mNGS in children infectious diseases. This study used the DNA extraction and library construction technology developed for children's low volume clinical samples to assess the sensitivity and specificity of mNGS in the diagnosis of infectious diseases, and the treatment outcome based on mNGS test results.
- Conditions
- Infectious Disease
- Being tested
- no intervention
- Keywords
- Metagenome next generation sequencing, Pediatric
- Medical subject headings
- Communicable Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
It's only observational study. No interventions.
| Study group | Role | What they receive |
|---|---|---|
| mNGS diagnosis | Using mNGS to diagnosis infectious disease of this group Receives: Other: no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
The sensitivity of metagenome next generation sequencing in the diagnosis of pediatric infectious disease
Samples from patients, who is suspected to central nervous system infection, respiratory infection, bloodstream infection and other unknown infections, will be tested by mNGS and traditional methods simultaneously. The sensitivity value will be calculated by comparing the detecting results of mNGS and traditional detecting methods.
Measured: From the date of first samples enrolled until the last samples detected, up to 3 years
The specificity of metagenome next generation sequencing in the diagnosis of pediatric infectious disease
Samples from patients, who is suspected to central nervous system infection, respiratory infection, bloodstream infection and other unknown infections, will be tested by mNGS and traditional methods simultaneously. The specificity value will be calculated by comparing the detecting results of mNGS and traditional detecting methods.
Measured: From the date of first samples enrolled until the last samples detected, up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2020
- Study start1 Jan 2020
- Primary completion1 Jul 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infectious DiseaseStudies of the same condition, open and under way.
- More trials run by Children's Hospital of Fudan UniversityThe 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
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wenhao Zhou, Doctor, Study chair, Children's Hospital of Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04320810
- Sponsor's protocol ID
- CHFudanU_NNICU13
- Status last verified
- May 2024
- First submitted
- 23 Mar 2020
- Last updated
- 13 May 2024
- 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 13 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing Metagenomic Approaches to Identify the Causes of Pediatric Infectious Diseases
- ClinicalTrials.gov ID
- NCT04320810
- Acronym / sponsor ID
- CHFudanU_NNICU13
- Conditions
- Infectious Disease
- Keywords
- Metagenome next generation sequencing, Pediatric
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Children's Hospital of Fudan UniversityUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 1 Jul 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 25 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.
Infectious diseases remain leading causes of mortality and morbidity in children. Rapid and accurate diagnosis of infectious diseases in children is important for developing an effective treatment and management strategy. However, the current diagnosis of infectious agents mainly depends on culture and molecular testing. Both of the methods either has long turnaround times or narrow detection range. Metagenome next generation sequencing (mNGS) has been applied to the diagnosis of central nervous system infection, lower respiratory tract infection and sepsis, which showed high positive rate, short turnaround time. However, there is currently no assessment of the diagnostic efficacy of mNGS in children infectious diseases. This study used the DNA extraction and library construction technology developed for children's low volume clinical samples to assess the sensitivity and specificity of mNGS in the diagnosis of infectious diseases, and the treatment outcome based on mNGS test results.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| mNGS diagnosis | – | Other: no interventionUsing mNGS to diagnosis infectious disease of this group |
Who may qualify
- Ages
- Up to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- This study mainly focus on the pediatric patients who is suspected of infectious disease.
Key inclusion criteria (4 listed)
- Patients are highly suspected of sepsis；
- Patients are highly suspected of respiratory infections；
- Patients are highly suspected of central nervous system infection；
- Patients are highly suspected of fever of unknown origin
Key exclusion criteria (3 listed)
- Congenital malformations；
- Patients requiring surgical intervention;
- Patients with skin barrier dysfunction
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 |
|---|---|---|
| no interventionIt's only observational study. No interventions. | Other | mNGS diagnosis |
Primary outcome
The sensitivity of metagenome next generation sequencing in the diagnosis of pediatric infectious disease
Time frame: From the date of first samples enrolled until the last samples detected, up to 3 years
Samples from patients, who is suspected to central nervous system infection, respiratory infection, bloodstream infection and other unknown infections, will be tested by mNGS and traditional methods simultaneously. The sensitivity value will be calculated by comparing the detecting results of mNGS and traditional detecting methods.
The specificity of metagenome next generation sequencing in the diagnosis of pediatric infectious disease
Time frame: From the date of first samples enrolled until the last samples detected, up to 3 years
Samples from patients, who is suspected to central nervous system infection, respiratory infection, bloodstream infection and other unknown infections, will be tested by mNGS and traditional methods simultaneously. The specificity value will be calculated by comparing the detecting results of mNGS and traditional detecting methods.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2024.
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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.
Wenhao Zhou, Doctor study chair
Children's Hospital of Fudan University
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 Infectious Disease, run by Children's Hospital of Fudan University 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 4 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 13 May 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 Wenhao Zhou, Doctor ((+86)021-64931003, zwhchfu@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The sensitivity of metagenome next generation sequencing in the diagnosis of pediatric infectious disease (time frame: From the date of first samples enrolled until the last samples detected, up to 3 years). 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 13 May 2024.