Pathogenic Bordetella Rapid Detection

NCT04535505 | Withdrawn

• 1 other identifier: BRD1.0
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

A CPA platform based on the CRISPR technology is going to established to achieve the goal of detecting pathogenic bordetella and drug resistance genes in one step. The accuracy of this platform will be checked through prospective diagnostic test evaluation methods. Bordetella pertussis isolation culture and identification would be set as a gold standard method.

Conditions

Pertussis

Keywords

Pertussis；Children；Diagnostic test；CPA; CRISPR

Outcome Measures

Primary Outcomes (1)

• Accuracy of the new CPA platform based on CRISPR technology, including sensitivity and specificity

  Bordetella pertussis isolation culture and identification would be taken as gold standard. The enrolled subjects would receive the detection of this research platform detection method and the gold standard at the same time. The measurement indexes are sensitivity and specificity.

  At enrollment

Study Arms (1)

pertussis test population

People with clinical diagnosis of suspected pertussis in outpatient and ward in the Children's Hospital of Fudan University will be collected as study subjects. Their nasopharyngeal swabs will be collected. Bordetella isolation culture and identification method is the gold standard, and the new CPA platform based on CRISPR technology is the method to be tested. Diagnostic values of this research platform would be detected.

Diagnostic Test: Detection pathogenic pertussis by cross primer constant temperature amplification (CPA) and drug resistant genes of erythromycin by CRISPR technology

Interventions

Detection pathogenic pertussis by cross primer constant temperature amplification (CPA) and drug resistant genes of erythromycin by CRISPR technology DIAGNOSTIC_TEST

This is an observational study and there are no interventions. The purpose of the study is to compare the accuracy （including sensitivity and specificity）of the new CPA platform based on CRISPR technology detection method and the gold standard in detecting pertussis patients.

pertussis test population

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

600 cases of suspected pertussis clinically diagnosed in the outpatient clinic and ward of Children's Hospital of Fudan University would be enrolled. The enrollment would start in October 2021 and end in June 2022. Patients who are admitted to the Children's Hospital of Fudan University during the enrollment period and are clinically suspected of pertussis would be the research objects. There are no special requirements for gender of the enrolled patients.

You may qualify if:

• Patients with continuous cough (paroxysmal cough) for more than 1 week, peripheral white blood cell 18×109/L (infants and young children), or\> 15×109/L (children), ineffective use of cephalosporin antibacterial drugs，and these patients whose nasopharyngeal swabs are collected for routine bordetella culture identification and drug susceptibility testing would be included as research object.

You may not qualify if:

• Patients with pertussis are suspected clinically but no nasopharyngeal swab specimens are collected or patients with pertussis are clinically excluded.

Sponsors & Collaborators

• Children's Hospital of Fudan University: lead

Study Sites (1)

Children's Hospital of Fudan University

Shanghai, Shanghai Municipality, 201102, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

Nasopharyngeal swab of a suspected pertussis patient

MeSH Terms

Conditions

Whooping Cough

Condition Hierarchy (Ancestors)

Bordetella Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Respiratory Tract Infections; Respiratory Tract Diseases

Study Officials

• Chuanqing Wang, Phd

  Children's Hospital of Fudan University

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2020
• First Posted: September 2, 2020
• Study Start: July 1, 2022
• Primary Completion: September 1, 2022
• Study Completion: December 1, 2022
• Last Updated: September 14, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)