Influenza A VirusNCT03924284
Novel Assays for Detection of Influenza Virus
An observational study of Influenza A Virus, run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
Seasonal influenza virus causes an estimated 0.3-0.6 million deaths per year. Avian influenza virus H5N1, H7N9 and H5N6 has fatality rate of over 30%. Swine influenza viruses from pigs have also infected humans. Molecular assays are now used routinely in the detection of influenza viruses. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Influenza A Virus
- What is being tested?
- PB2 gene RT-PCR; NS gene RT-PCR
- How many people
- 0 participants
- Where
- 1 siteHong Kong
- Study dates
- 18 Apr 2019to 30 Jul 2019
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: These archived nasopharyngeal and saliva specimens are collected from patients in Queen Mary Hospital
Who may be able to join
- Nasopharyngeal or saliva specimens of patients in Queen Mary Hospital of Hong Kong
- Tested for influenza A virus using a commercially available assay or by the Public Health Laboratory Services Branch in Hong Kong
Who cannot join
- Insufficient specimen volume
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Novel Molecular Assays for the Detection of Influenza Virus
Seasonal influenza virus causes an estimated 0.3-0.6 million deaths per year. Avian influenza virus H5N1, H7N9 and H5N6 has fatality rate of over 30%. Swine influenza viruses from pigs have also infected humans.
Molecular assays are now used routinely in the detection of influenza viruses. The M gene is often used as the target for all influenza A viruses because the nucleotide sequence of this gene is relatively conserved among all the influenza A viruses. The World Health Organization and the US Centers for Disease Control and Prevention (CDC) have published protocols for molecular detection of influenza A virus M gene.
However, recent studies have shown that mutations in the M gene have led to a reduced sensitivity of RT-PCR assay targeting this gene. Therefore, it is important to use alternative conserved genes as the target of RT-PCR. In this study, our aim is to evaluate two new RT-PCR assays that are based on PB2 and NS gene segment.
Read the detailed description
- Background
- Seasonal influenza virus causes an estimated 0.3-0.6 million deaths per year. Avian influenza virus H5N1, H7N9 and H5N6 has fatality rate of over 30%. Swine influenza viruses from pigs have also infected humans.
- Molecular assays are now used routinely in the detection of influenza viruses. The M gene is often used as the target for all influenza A viruses because the nucleotide sequence of this gene is relatively conserved among all the influenza A viruses. The World Health Organization and the US Centers for Disease Control and Prevention (CDC) have published protocols for molecular detection of influenza A virus M gene.
- However, recent studies have shown that mutations in the M gene have led to a reduced sensitivity of RT-PCR assay targeting this gene. Therefore, it is important to use alternative conserved genes as the target of RT-PCR. In this study, our aim is to evaluate two new RT-PCR assays that are based on PB2 and NS gene segment
II. Study objective -To evaluate the sensitivity and specificity of 2 new RT-PCR assays
III. Overall study design
- The investigators will randomly retrieve archived nasopharyngeal and saliva specimens that were previously tested for influenza A virus using commercially available assays in our laboratory, tested for influenza A virus at the Public Health Laboratory Service Branch in Hong Kong. These specimens will be tested for influenza A virus by 4 different RT-PCR assays as listed below:
- Our new RT-PCR assay targeting PB2 gene
- Our new RT-PCR assay targeting NS gene
- M gene RT-PCR published by the World Health Organization
- M gene RT-PCR published by the US CDC Sensitivity, specificity, positive predictive value and negative predictive value will be determined. IV. Nucleic acid extraction and real-time reverse transcription-polymerase chain reaction (RT-PCR) for influenza A virus
- Saliva and nasopharyngeal specimens will be subjected to total nucleic acid (TNA) extraction by NucliSENS easyMAG (BioMerieux, Boxtel, Netherlands).
- Monoplex real-time RT-PCR assays for influenza A virus will be performed. The primers and probes for the M gene RT-PCR have been published by the WHO and the US CDC.
- Sample size:
- The investigators will perform all 4 RT-PCR assays on a total of 320 specimens, including
- 80 nasopharyngeal specimens which tested positive for influenza A by commercially-available molecular assays or by testing performed at the Public Health Laboratory Services Branch in Hong Kong
- 80 nasopharyngeal specimens which tested negative for influenza A by commercially-available molecular assays or by testing performed at the Public Health Laboratory Services Branch in Hong Kong
- 80 saliva specimens which tested positive for influenza A by commercially-available molecular assays
- 80 saliva specimens which tested negative for influenza A by commercially-available molecular assays
- Conditions
- Influenza A Virus
- Being tested
- PB2 gene RT-PCR; NS gene RT-PCR
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PB2 gene RT-PCR; NS gene RT-PCRDiagnostic test
PB2 gene RT-PCR: RT-PCR targeting the PB2 gene of influenza A virus NS gene RT-PCR: RT-PCR targeting NS gene of influenza A virus
| Study group | Role | What they receive |
|---|---|---|
| NPA positive | NPA specimens that are tested positive for influenza A virus by commercially available assay or by the Public Health Laboratory Services Branch of Hong Kong Receives: Diagnostic Test: PB2 gene RT-PCR; NS gene RT-PCR | |
| NPA negative | NPA specimens that are tested negative for influenza A virus by commercially available assay or by the Public Health Laboratory Services Branch of Hong Kong Receives: Diagnostic Test: PB2 gene RT-PCR; NS gene RT-PCR | |
| Saliva positive | Saliva specimens that are tested positive for influenza A virus by commercially available assay or by the Public Health Laboratory Services Branch of Hong Kong Receives: Diagnostic Test: PB2 gene RT-PCR; NS gene RT-PCR | |
| Saliva negative | Saliva specimens that are tested negative for influenza A virus by commercially available assay or by the Public Health Laboratory Services Branch of Hong Kong Receives: Diagnostic Test: PB2 gene RT-PCR; NS gene RT-PCR |
What is being measured
The primary outcome is the main question the study is designed to answer.
RT-PCR result
The result of RT-PCR can be positive or negative
Measured: Through study completion, an average of 2 months
Secondary outcomes (1)
Cycle threshold value
The cycle threshold is a surrogate for viral load
Measured: Through study completion, an average of 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2019
- Study start18 Apr 2019 (estimated)
- Primary completion30 Jul 2019 (estimated)
- Study completion30 Jul 2019 (estimated)
Why it stopped: Wrong entry
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Influenza A VirusStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- 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
- Retrospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Kelvin Kai-Wang To, The University of Hong Kong
- Investigators
- Kelvin To, MD, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03924284
- Sponsor's protocol ID
- FluA_20190110
- Status last verified
- Apr 2019
- First submitted
- 11 Jan 2019
- Last updated
- 25 Apr 2019
- Results posted
- No
- Data monitoring committee
- 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 25 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Novel Molecular Assays for the Detection of Influenza Virus
- ClinicalTrials.gov ID
- NCT03924284
- Acronym / sponsor ID
- FluA_20190110
- Conditions
- Influenza A Virus
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Wrong entry
- Enrolment
- 0 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 18 Apr 2019 (estimated)
- Primary completion
- 30 Jul 2019 (estimated)
- Study completion
- 30 Jul 2019 (estimated)
- First posted
- 23 Apr 2019 (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.
Seasonal influenza virus causes an estimated 0.3-0.6 million deaths per year. Avian influenza virus H5N1, H7N9 and H5N6 has fatality rate of over 30%. Swine influenza viruses from pigs have also infected humans.
Molecular assays are now used routinely in the detection of influenza viruses. The M gene is often used as the target for all influenza A viruses because the nucleotide sequence of this gene is relatively conserved among all the influenza A viruses. The World Health Organization and the US Centers for Disease Control and Prevention (CDC) have published protocols for molecular detection of influenza A virus M gene.
However, recent studies have shown that mutations in the M gene have led to a reduced sensitivity of RT-PCR assay targeting this gene. Therefore, it is important to use alternative conserved genes as the target of RT-PCR. In this study, our aim is to evaluate two new RT-PCR assays that are based on PB2 and NS gene segment.
Detailed description
- Background
- Seasonal influenza virus causes an estimated 0.3-0.6 million deaths per year. Avian influenza virus H5N1, H7N9 and H5N6 has fatality rate of over 30%. Swine influenza viruses from pigs have also infected humans.
- Molecular assays are now used routinely in the detection of influenza viruses. The M gene is often used as the target for all influenza A viruses because the nucleotide sequence of this gene is relatively conserved among all the influenza A viruses. The World Health Organization and the US Centers for Disease Control and Prevention (CDC) have published protocols for molecular detection of influenza A virus M gene.
- However, recent studies have shown that mutations in the M gene have led to a reduced sensitivity of RT-PCR assay targeting this gene. Therefore, it is important to use alternative conserved genes as the target of RT-PCR. In this study, our aim is to evaluate two new RT-PCR assays that are based on PB2 and NS gene segment
II. Study objective -To evaluate the sensitivity and specificity of 2 new RT-PCR assays
III. Overall study design
- The investigators will randomly retrieve archived nasopharyngeal and saliva specimens that were previously tested for influenza A virus using commercially available assays in our laboratory, tested for influenza A virus at the Public Health Laboratory Service Branch in Hong Kong. These specimens will be tested for influenza A virus by 4 different RT-PCR assays as listed below:
- Our new RT-PCR assay targeting PB2 gene
- Our new RT-PCR assay targeting NS gene
- M gene RT-PCR published by the World Health Organization
- M gene RT-PCR published by the US CDC Sensitivity, specificity, positive predictive value and negative predictive value will be determined. IV. Nucleic acid extraction and real-time reverse transcription-polymerase chain reaction (RT-PCR) for influenza A virus
- Saliva and nasopharyngeal specimens will be subjected to total nucleic acid (TNA) extraction by NucliSENS easyMAG (BioMerieux, Boxtel, Netherlands).
- Monoplex real-time RT-PCR assays for influenza A virus will be performed. The primers and probes for the M gene RT-PCR have been published by the WHO and the US CDC.
- Sample size:
- The investigators will perform all 4 RT-PCR assays on a total of 320 specimens, including
- 80 nasopharyngeal specimens which tested positive for influenza A by commercially-available molecular assays or by testing performed at the Public Health Laboratory Services Branch in Hong Kong
- 80 nasopharyngeal specimens which tested negative for influenza A by commercially-available molecular assays or by testing performed at the Public Health Laboratory Services Branch in Hong Kong
- 80 saliva specimens which tested positive for influenza A by commercially-available molecular assays
- 80 saliva specimens which tested negative for influenza A by commercially-available molecular assays
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| NPA positive | – | Diagnostic Test: PB2 gene RT-PCR; NS gene RT-PCRNPA specimens that are tested positive for influenza A virus by commercially available assay or by the Public Health Laboratory Services Branch of Hong Kong |
| NPA negative | – | Diagnostic Test: PB2 gene RT-PCR; NS gene RT-PCRNPA specimens that are tested negative for influenza A virus by commercially available assay or by the Public Health Laboratory Services Branch of Hong Kong |
| Saliva positive | – | Diagnostic Test: PB2 gene RT-PCR; NS gene RT-PCRSaliva specimens that are tested positive for influenza A virus by commercially available assay or by the Public Health Laboratory Services Branch of Hong Kong |
| Saliva negative | – | Diagnostic Test: PB2 gene RT-PCR; NS gene RT-PCRSaliva specimens that are tested negative for influenza A virus by commercially available assay or by the Public Health Laboratory Services Branch of Hong Kong |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- These archived nasopharyngeal and saliva specimens are collected from patients in Queen Mary Hospital
Key inclusion criteria (2 listed)
- Nasopharyngeal or saliva specimens of patients in Queen Mary Hospital of Hong Kong
- Tested for influenza A virus using a commercially available assay or by the Public Health Laboratory Services Branch in Hong Kong
Key exclusion criteria (1 listed)
- Insufficient specimen volume
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 |
|---|---|---|
| PB2 gene RT-PCR; NS gene RT-PCRPB2 gene RT-PCR: RT-PCR targeting the PB2 gene of influenza A virus NS gene RT-PCR: RT-PCR targeting NS gene of influenza A virus | Diagnostic test | NPA negative, NPA positive, Saliva negative, Saliva positive |
Primary outcome
RT-PCR result
Time frame: Through study completion, an average of 2 months
The result of RT-PCR can be positive or negative
1 secondary outcome
Cycle threshold value
Time frame: Through study completion, an average of 2 months
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 25 Apr 2019.
- Individual participant dataSharing planned: No
Related trials for Influenza A Virus
Not yet recruitingPhase 1
Safety and Immunogenicity of Chimeric Hemagglutinin mRNA Vaccine Candidates
Influenza
RecruitingPhase 1
pH1N1 Blinded Challenge Study
Influenza
RecruitingPhase 3
A Study to Evaluate the Safety and Efficacy of MK-1406/CD388 for Prevention of Influenza (MK-1406-005/CD388.SQ.3.06)
Influenza
RecruitingPhase 1
A Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1010 in Healthy Children
Seasonal Influenza
RecruitingPhase 1
A Trial to Evaluate the Effect of CD388/MK1406 on the Immunogenicity of Fluzone® HD Vaccine (CD388.SQ.1.08/MK-1406-007)
Healthy Participants
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.
Kelvin To, MD principal investigator
The University of Hong Kong
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 Influenza A Virus, run by The University of Hong Kong at 1 site in Hong Kong.
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 2 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 25 Apr 2019. 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 Hong Kong. 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?
RT-PCR result (time frame: Through study completion, an average of 2 months). 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 25 Apr 2019.