Identifying causes of infectious diseases in children using advanced sequencing techniques
Developing Metagenomic Approaches to Identify the Causes of Pediatric Infectious Diseases
This study is testing a new DNA sequencing method to see if it can quickly and accurately diagnose infectious diseases in children, like sepsis and respiratory infections.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | N/A to 16 Years |
| Sex | All |
| Sponsor | Children's Hospital of Fudan University Academic / other |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT04320810 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the effectiveness of metagenome next generation sequencing (mNGS) in diagnosing infectious diseases in pediatric patients. By utilizing advanced DNA extraction and library construction methods tailored for small clinical samples, the study will assess the sensitivity and specificity of mNGS for conditions such as sepsis, respiratory infections, and central nervous system infections. The goal is to provide rapid and accurate diagnostic results that can inform treatment strategies for children with suspected infectious diseases.
Who should consider this trial
Good fit: Ideal candidates for this study are pediatric patients suspected of having sepsis, respiratory infections, central nervous system infections, or fever of unknown origin.
Not a fit: Patients with congenital malformations, those requiring surgical intervention, or individuals with skin barrier dysfunction may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to faster and more accurate diagnoses of infectious diseases in children, improving treatment outcomes.
How similar studies have performed: While mNGS has shown promise in diagnosing infections in other populations, this specific application in pediatric infectious diseases is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * Congenital malformations； * Patients requiring surgical intervention; * Patients with skin barrier dysfunction
Where this trial is running
Shanghai, Shanghai Municipality
- Children Hospital of Fudan University — Shanghai, Shanghai Municipality, China (Recruiting)
Study contacts
- Study coordinator: Wenhao Zhou, Doctor
- Email: zwhchfu@126.com
- Phone: (+86)021-64931003
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.