Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05149547
Other study ID # mNGS for FN(2021PHB362-001)
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date October 15, 2021
Est. completion date August 31, 2022

Study information

Verified date November 2021
Source Peking University People's Hospital
Contact Yuqian Sun, MD
Phone 861088324577
Email sunyuqian83@hotmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 300
Est. completion date August 31, 2022
Est. primary completion date May 31, 2022
Accepts healthy volunteers
Gender All
Age group 15 Years and older
Eligibility Inclusion Criteria: - hematologic disease - febrile neutropenia Exclusion Criteria: - refuse to consent - age<=14 - not caused by infection

Study Design


Intervention

Diagnostic Test:
blood culture versus mNGS detection
peripheral 4ml for mNGS detection

Locations

Country Name City State
China Yuqian Sun Beijing

Sponsors (4)

Lead Sponsor Collaborator
Peking University People's Hospital Hebei Yanda Ludaopei Hospital, Peking University First Hospital, Peking University International Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary diagnosis performance the sensitivity and specificity of mNGS 14 days after sapmpling
See also
  Status Clinical Trial Phase
Recruiting NCT06055777 - Study of the Safety, Tolerability, and PK of SZEY-2108 Administered Intravenously to HVs in SAD and MAD Cohorts Phase 1
Recruiting NCT05578196 - Fecal Microbial Transplantation in Critically Ill Patients With Severe Infections. N/A
Recruiting NCT05793983 - S100A8/A9 and Innate Immunity in Liver Disease
Active, not recruiting NCT05963269 - The Effect of the Game on Students' Intramuscular Injection Skills N/A
Not yet recruiting NCT06026852 - Validation of Betalactam ML Prediction Models - TDMAide N/A
Not yet recruiting NCT02222779 - Quantification of Transition Metals N/A
Completed NCT01976234 - Stored RBC Transfusion and Immonomodulation N/A
Completed NCT02345135 - Susceptibility to Infections in Ataxia Telangiectasia N/A
Completed NCT01530763 - Safety and Efficacy Study of Ceftaroline Versus a Comparator in Pediatric Subjects With Community Acquired Bacterial Pneumonia (CABP) Phase 2/Phase 3
Completed NCT01158560 - A Trial of Vitamin D and Health Advice for the Prevention of Upper Respiratory Tract Infections Phase 3
Completed NCT01176786 - Reusable Versus Disposable Draping System in Breast Reconstruction Surgery N/A
Active, not recruiting NCT05284097 - Ad26.ZEBOV, MVA-BN-Filo Vaccination in Children and Adults Previously Vaccinated With Control in the EBOVAC-Salone Study Phase 2
Enrolling by invitation NCT06055712 - Antibiotic Prophylaxis in Pediatric Open Fractures Phase 4
Not yet recruiting NCT06402292 - Surgical Treatment of Osteoarticular Infections Using Bioactive Bone Substitute N/A
Not yet recruiting NCT06338345 - Pharmacokinetics and Modelling of Beta-Lactam in ECMO-VA Patients N/A
Recruiting NCT06002685 - Partners in Children's Health (CSN): A Randomized Trial of an Attachment Based Intervention N/A
Completed NCT02802059 - E. Coli Nissle 1917 - Suspension for Infection Prophylaxis Phase 3
Completed NCT05289674 - The Effect of Lactoferrin in High Calorie Formula on IL-6 and IL10 in Children With Failure to Thrive and Infection N/A
Recruiting NCT05770765 - Creation of a Bank of Biological Materials and Associated Data Related to Patients With Infectious and Tropical Diseases
Completed NCT05389540 - Rural South and Southeast Asia Household Health Survey