Pathogenic Bordetella Rapid Detection
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT04535505 |
|
Recruitment Status :
Not yet recruiting
First Posted : September 2, 2020
Last Update Posted : February 9, 2022
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
| Condition or disease | Intervention/treatment |
|---|---|
| Pertussis | Diagnostic Test: Detection pathogenic pertussis by cross primer constant temperature amplification (CPA) and drug resistant genes of erythromycin by CRISPR technology |
Pertussis is an acute respiratory infectious disease caused by bordetella pertussis. Although it is a vaccine-preventable disease, outbreaks and epidemic cases of whooping cough worldwide have been reported from time to time. Bordella parapertussis, Bodella bronchiseptica, and bordetella hosei can cause pertussis-like diseases with symptoms similar to those of whooping cough. The clinical manifestations are difficult to distinguish, and they are easily reported as cases of whooping cough through the infectious disease network.
The diagnosis of the infectious diseases caused by the four pathogenic bodella mainly relies on laboratory pathogenic testing. At present, the laboratory tests of bordetella that can be carried out in the clinical microbiology laboratory include culture, bordetella pertussis specific antibody (PT-IgG) serological detection, and bordetella pertussis nucleic acid PCR detection. However, none of them meet the requirements of early diagnosis.
Cross primer constant temperature amplification (CPA) is nucleic acid constant temperature amplification technology with independent property rights. The fully automated nucleic acid detection platform equipped with CPA technology would make the detection of four pathogenic bordetella easy, quick and safe and accurate.
As pathogenic bodella is difficult to cultivate and there is no standard for drug susceptibility test. Studies have shown that 57.4% of the isolated clinical isolates of bordetella pertussis have MIC value for erthomycin ≥256 μg/mL , and 23s rRNA 2047 site adenine (A) were mutated to guanine (G).CRISPR/Cas is an immune system in bacteria that can specifically recognize invading nucleic acids and shear them. The CRISPR technology developed based on the CRISPR/Cas principle can detect single point mutations in genes.
The hypothesis that 4 pathogenic bordetella and their erythromycin resistance would be detected in one testing platform simultaneously. The accuracy, reliability, predictive value of this platform would be checked through prospective diagnostic test evaluation methods. Bordetella pertussis isolation culture and identification would be as the gold standard method.
| Study Type : | Observational |
| Estimated Enrollment : | 600 participants |
| Observational Model: | Other |
| Time Perspective: | Prospective |
| Official Title: | Establishment a Nucleic Acid Rapid Detection Technology Platform for Detecting Pathogenic Bordetella and Its Drug Resistance Genes |
| Estimated Study Start Date : | April 2022 |
| Estimated Primary Completion Date : | June 2022 |
| Estimated Study Completion Date : | September 2022 |
| Group/Cohort | Intervention/treatment |
|---|---|
|
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
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. |
- Accuracy of the new CPA platform based on CRISPR technology, including sensitivity and specificity [ Time Frame: At enrollment ]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.
Biospecimen Retention: Samples With DNA
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | up to 18 Years (Child, Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Patients with pertussis are suspected clinically but no nasopharyngeal swab specimens are collected or patients with pertussis are clinically excluded.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04535505
| Contact: Chuanqing Wang, Phd | +86 18017591167 | Chuanqing523@163.com |
| China, Shanghai | |
| Children's Hospital of Fudan University | |
| Shanghai, Shanghai, China, 201102 | |
| Contact: Chunaqing Wang +86 18017591167 Chuanqing523@163.com | |
| Principal Investigator: Chunaqing Wang | |
| Principal Investigator: Qimin You | |
| Principal Investigator: Pan Fu | |
| Principal Investigator: Chunling Li | |
| Principal Investigator: Saige Chen | |
| Principal Investigator: Leiyan He | |
| Sub-Investigator: Yuan Jiang | |
| Study Director: | Chuanqing Wang, Phd | Children's Hospital of Fudan University |
| Responsible Party: | Children's Hospital of Fudan University |
| ClinicalTrials.gov Identifier: | NCT04535505 |
| Other Study ID Numbers: |
BRD1.0 |
| First Posted: | September 2, 2020 Key Record Dates |
| Last Update Posted: | February 9, 2022 |
| Last Verified: | October 2021 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
|
Pertussis；Children；Diagnostic test；CPA; CRISPR |
|
Whooping Cough Bordetella Infections Gram-Negative Bacterial Infections Bacterial Infections Bacterial Infections and Mycoses Infections Respiratory Tract Infections Respiratory Tract Diseases Erythromycin |
Erythromycin Estolate Erythromycin Ethylsuccinate Erythromycin stearate Anti-Bacterial Agents Anti-Infective Agents Gastrointestinal Agents Protein Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |