PertussisNCT04535505
Pathogenic Bordetella Rapid Detection
An observational study of Pertussis, run by Children's Hospital of Fudan University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Pertussis
- What is being tested?
- Detection pathogenic pertussis by cross primer constant temperature amplification (CPA) and drug resistant genes of erythromycin by CRISPR technology
- How many people
- 0 participants
- Where
- 1 siteChina
- Study dates
- Jul 2022to Dec 2022
- 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 18 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- 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.
Who cannot join
- Patients with pertussis are suspected clinically but no nasopharyngeal swab specimens are collected or patients with pertussis are clinically excluded.
Trial locations and contacts
1 site in 1 country.
China1 site
Children's Hospital of Fudan University
Shanghai, Shanghai Municipality, 201102
About this study
Official title: Establishment a Nucleic Acid Rapid Detection Technology Platform for Detecting Pathogenic Bordetella and Its Drug Resistance Genes
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.
Read the detailed description
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.
- Conditions
- Pertussis
- Being tested
- Detection pathogenic pertussis by cross primer constant temperature amplification (CPA) and drug resistant genes of erythromycin by CRISPR technology
- Keywords
- Pertussis；Children；Diagnostic test；CPA; CRISPR
- Medical subject headings
- Whooping Cough
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Detection pathogenic pertussis by cross primer constant temperature amplification (CPA) and drug resistant genes of erythromycin by CRISPR technologyDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Detection pathogenic pertussis by cross primer constant temperature amplification (CPA) and drug resistant genes of erythromycin by CRISPR technology |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2020
- Study startJul 2022 (estimated)
- Primary completionSep 2022 (estimated)
- Study completionDec 2022 (estimated)
Why it stopped: Not as a lead unit
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PertussisStudies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chuanqing Wang, Phd, Study director, Children's Hospital of Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04535505
- Sponsor's protocol ID
- BRD1.0
- Status last verified
- Sep 2022
- First submitted
- 28 Aug 2020
- Last updated
- 14 Sep 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishment a Nucleic Acid Rapid Detection Technology Platform for Detecting Pathogenic Bordetella and Its Drug Resistance Genes
- ClinicalTrials.gov ID
- NCT04535505
- Acronym / sponsor ID
- BRD1.0
- Conditions
- Pertussis
- Keywords
- Pertussis；Children；Diagnostic test；CPA; CRISPR
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Not as a lead unit
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Children's Hospital of Fudan UniversityUniversity, hospital or other
- Study start
- Jul 2022 (estimated)
- Primary completion
- Sep 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 2 Sep 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.
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.
Detailed description
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| pertussis test population | – | Diagnostic Test: Detection pathogenic pertussis by cross primer constant temperature amplification (CPA) and drug resistant genes of erythromycin by CRISPR technologyPeople 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. |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Patients with pertussis are suspected clinically but no nasopharyngeal swab specimens are collected or patients with pertussis are clinically excluded.
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 |
|---|---|---|
| Detection pathogenic pertussis by cross primer constant temperature amplification (CPA) and drug resistant genes of erythromycin by CRISPR technologyThis 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. | Diagnostic test | pertussis test population |
Primary outcome
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.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2022.
- Individual participant dataSharing planned: No
Related trials for Pertussis
RecruitingPhase 2
A Phase II Clinical Trial of Absorbed Acellular Pertussis (Two-Component) Diphtheria-Tetanus Combined Vaccine (For Adults and Adolescents)
Pertussis (Whooping Cough), Diphtheria
RecruitingPhase 1/2
A Phase I/II Clinical Trial of the Diphtheria, Tetanus, Acellular Component Pertussis and Sabin Inactivated Poliomyelitis Vaccine Adsorbed
Diphtheria, Pertussis
RecruitingPhase 4
Concurrent Versus Sequential Administration of Tdap and RSV Vaccines in Pregnancy
RSV, Tdap - Tetanus, Diphtheria and Acellular Pertussis Vaccination
Not yet recruitingObservational study
Assessment of the Acceptability of, and Factors Associated With, Recommended Vaccinations During Pregnancy in Maternity Units in the Ile-de-France Region
Vaccination Coverage Among Pregnant Women
Not yet recruitingPhase 1/2
Safety and Immunogenicity of a Combined Diphtheria, Tetanus, Whole Cell Pertussis, Hepatitis B, Recombinant Poliomyelitis and Haemophilus Influenzae Type b (Hib) Vaccine (SIIPL DTwP-HepB-rPV-Hib)
Diptheria Immunization, Tetanus Immunization
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.
Chuanqing Wang, Phd study director
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 Pertussis, 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 1 inclusion and 1 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: withdrawn, as of the sponsor's last update on 14 Sep 2022. 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of the new CPA platform based on CRISPR technology, including sensitivity and specificity (time frame: At enrollment). 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 14 Sep 2022.