Prospective StudiesNPNCT01979705
Detect Novel Pathogens and Characterize Emerging Infections
An observational study of Prospective Studies, run by Singapore General Hospital at 1 site in Singapore.
Trial summary
Infectious disease is the single biggest cause of death worldwide. New infectious agents,such as the Severe Acute Respiratory Syndrome coronavirus and new strains of influenza continually emerge and require new investigations to understand pathogen biology and pathogenesis in the host. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Prospective Studies
- How many people
- 100 participants
- Where
- 1 siteSingapore
- Study dates
- Aug 2013to Jun 2020
- 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: This is a prospective study with inclusion criteria as specified below: Inclusion criteria: Any person admitted to Singapore General Hospital or seen as an outpatient in the Specialist Outpatient Clinic who has: 1. clinical history and/or clinical syndromes compatible with a suspected novel/re-emerging infective etiological agent.
Who may be able to join
- Any person admitted to Singapore General Hospital or seen as an outpatient in the Specialist Outpatient Clinic who has:
- 1. clinical history and/or clinical syndromes compatible with a suspected novel/re-emerging infective etiological agent
Who cannot join
- 1. Any person unable to give informed consent and for whom no legally acceptable representative is available
Trial locations and contacts
1 site in 1 country.
Singapore1 site, 1 recruiting
- Recruiting
Singapore General Hospital
Singapore, 168751
Sabariah Mortar, +65 6321 3479, sabariah.mohamed.mortar@sgh.com.sg
Tan Ban Hock
About this study
Official title: A Prospective Study to Detect Novel Pathogens and Characterize Emerging Infections
Infectious disease is the single biggest cause of death worldwide. New infectious agents,such as the Severe Acute Respiratory Syndrome coronavirus and new strains of influenza continually emerge and require new investigations to understand pathogen biology and pathogenesis in the host. Witness the Influenza A pandemic. Concerns about new viruses and their impact on health and the economy are also increasing. Current alerts sent out by the Ministry of Health (about the novel coronavirus and the Avian influenza A virus) are but cases in point. These likely reflect advances in science, which have allowed novel pathogens to be identified.
Because of its geography, Singapore is vulnerable to new pathogens through importation or the global travel of its citizens. Hence we must be ever ready to meet unexpected challenges anytime.
Read more
On the administrative front, Singapore General Hospital has a Disease Outbreak Task-force which has in place many plans that can be activated should there be a large-scale epidemic.
What is missing thus far is a program that will enable us to perform scientific studies in the setting of an epidemic. Hence in this study, we will, in collaboration with the Program in Emerging Infectious Diseases (EID) in Duke-National University of Singapore Postgraduate Medical School, attempt to (i) detect novel, previously undescribed pathogens; (ii) characterize viruses (not necessarily novel but emerging and re-emerging) that are raising concern or causing clusters or epidemics in the hospital and/or country; (iii) characterize immune responses to such viruses in healthcare workers as well as patients (those affected by these viruses and those exposed to the affected). The techniques that will be used will be those not routinely available in a hospital's service labs.
Some patients will remain undiagnosable with the best available technology. Since new laboratory tools that can detect previously undiagnosed pathogens may become available in the future, the study also aims to archive specimens from patients whose illnesses remain undiagnosed.
Read the detailed description
This study has the following aims:
- To detect novel, previously undescribed pathogens.
- To characterize viruses (not necessarily novel but emerging and re-emerging) that are raising concern or causing clusters or epidemics in the hospital and/or country;
- To characterize immune responses to such viruses in patients.
- To archive specimens with no identifiable infectious etiological agents for future testing.
A recent global analysis documented that emerging infectious disease events have increased significantly over time. Singapore has not been spared with the list of pathogens since the late 1990s, including Nipahn virus, SARS coronavirus, dengue, chikungunya, and 2009 H1N1. As is widely known, the novel coronavirus may potentially impact Singapore as Haj pilgrims from Singapore travel to Saudi Arabia and are potentially exposed to this virus.
Novel pathogens continue to be discovered. An example of this is the Severe Fever with Thrombocytopenia Syndrome bunyavirus in Henan, China. Appropriately a commentary accompanying the report identified China as a country with the largest potential for emerging or re-emerging infectious disease, due to the close proximity of animals and human populations. Similarly, Southeast Asia was identified as a potential hotspot, citing the avian influenza pandemic and Nipahn virus outbreak. As such, it is obvious that there is a need to better define undiagnosed infective syndromes in Singapore, and subsequently characterize emerging pathogens.
In Singapore, there is currently a lack of research focus on discovery of novel pathogens. Our current protocol is an attempt to fill this gap. This proposal brings together experts in clinical infectious diseases in SGH, world renowned scientists in laboratory diagnostics of infectious diseases and public health epidemiology experts in Duke-NUS Postgraduate Medical School. We hope by employing state of the art technologies, we will be at the frontier of new pathogen discovery.
- Conditions
- Prospective Studies
What is being measured
The primary outcome is the main question the study is designed to answer.
Detecting of Novel Pathogens
- Clinical data collection through case records, and interview of patients or next-of-kin or friend in the event information is unavailable or incompletely documented in the case records.
- Sample collection will be performed according to the following frequency:
- First day of enrolment: blood draw (by weight) not more than 20ml, nasal (and/or nasopharyngeal ) and/or throat swab, stool and urine sample.
- On days 2, 3, 5, 7, 10, 14 and 28: blood (by weight) not more than 10 ml, nasal (and/or nasopharyngeal l) and/or throat swab, stool and urine sample. On D28, blood (by weight) not more than 20ml, will be drawn as most immune response changes manifest by then.
If available, urine and stool sample will be collected. If the subject is intubated, endotracheal aspirate will replace nasal and throat swab. Sample collection for research will be done at the same time as samples for clinical testing as far as possible, to minimize patient discomfort.
Measured: Day 1 - Day 28 of recruitment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2013 (estimated)
- Study startAug 2013
- Primary completionJan 2020 (estimated)
- Study completionJun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prospective StudiesStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Singapore General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tan Ban Hock, Principal investigator, Singapore General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01979705
- Sponsor's protocol ID
- NP 07/2013
- Acronym
- NP
- Status last verified
- Oct 2017
- First submitted
- 30 Oct 2013
- Last updated
- 6 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study to Detect Novel Pathogens and Characterize Emerging Infections
- ClinicalTrials.gov ID
- NCT01979705
- Acronym / sponsor ID
- NP / NP 07/2013
- Conditions
- Prospective Studies
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Singapore General HospitalUniversity, hospital or other
- Study start
- Aug 2013 (actual)
- Primary completion
- Jan 2020 (estimated)
- Study completion
- Jun 2020 (estimated)
- First posted
- 8 Nov 2013 (estimated)
- 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.
Infectious disease is the single biggest cause of death worldwide. New infectious agents,such as the Severe Acute Respiratory Syndrome coronavirus and new strains of influenza continually emerge and require new investigations to understand pathogen biology and pathogenesis in the host. Witness the Influenza A pandemic. Concerns about new viruses and their impact on health and the economy are also increasing. Current alerts sent out by the Ministry of Health (about the novel coronavirus and the Avian influenza A virus) are but cases in point. These likely reflect advances in science, which have allowed novel pathogens to be identified.
Because of its geography, Singapore is vulnerable to new pathogens through importation or the global travel of its citizens. Hence we must be ever ready to meet unexpected challenges anytime.
On the administrative front, Singapore General Hospital has a Disease Outbreak Task-force which has in place many plans that can be activated should there be a large-scale epidemic.
What is missing thus far is a program that will enable us to perform scientific studies in the setting of an epidemic. Hence in this study, we will, in collaboration with the Program in Emerging Infectious Diseases (EID) in Duke-National University of Singapore Postgraduate Medical School, attempt to (i) detect novel, previously undescribed pathogens; (ii) characterize viruses (not necessarily novel but emerging and re-emerging) that are raising concern or causing clusters or epidemics in the hospital and/or country; (iii) characterize immune responses to such viruses in healthcare workers as well as patients (those affected by these viruses and those exposed to the affected). The techniques that will be used will be those not routinely available in a hospital's service labs.
Some patients will remain undiagnosable with the best available technology. Since new laboratory tools that can detect previously undiagnosed pathogens may become available in the future, the study also aims to archive specimens from patients whose illnesses remain undiagnosed.
Detailed description
This study has the following aims:
- To detect novel, previously undescribed pathogens.
- To characterize viruses (not necessarily novel but emerging and re-emerging) that are raising concern or causing clusters or epidemics in the hospital and/or country;
- To characterize immune responses to such viruses in patients.
- To archive specimens with no identifiable infectious etiological agents for future testing.
A recent global analysis documented that emerging infectious disease events have increased significantly over time. Singapore has not been spared with the list of pathogens since the late 1990s, including Nipahn virus, SARS coronavirus, dengue, chikungunya, and 2009 H1N1. As is widely known, the novel coronavirus may potentially impact Singapore as Haj pilgrims from Singapore travel to Saudi Arabia and are potentially exposed to this virus.
Novel pathogens continue to be discovered. An example of this is the Severe Fever with Thrombocytopenia Syndrome bunyavirus in Henan, China. Appropriately a commentary accompanying the report identified China as a country with the largest potential for emerging or re-emerging infectious disease, due to the close proximity of animals and human populations. Similarly, Southeast Asia was identified as a potential hotspot, citing the avian influenza pandemic and Nipahn virus outbreak. As such, it is obvious that there is a need to better define undiagnosed infective syndromes in Singapore, and subsequently characterize emerging pathogens.
In Singapore, there is currently a lack of research focus on discovery of novel pathogens. Our current protocol is an attempt to fill this gap. This proposal brings together experts in clinical infectious diseases in SGH, world renowned scientists in laboratory diagnostics of infectious diseases and public health epidemiology experts in Duke-NUS Postgraduate Medical School. We hope by employing state of the art technologies, we will be at the frontier of new pathogen discovery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- This is a prospective study with inclusion criteria as specified below: Inclusion criteria: Any person admitted to Singapore General Hospital or seen as an outpatient in the Specialist Outpatient Clinic who has: 1. clinical history and/or clinical syndromes compatible with a suspected novel/re-emerging infective etiological agent.
Key inclusion criteria (2 listed)
- Any person admitted to Singapore General Hospital or seen as an outpatient in the Specialist Outpatient Clinic who has:
- 1. clinical history and/or clinical syndromes compatible with a suspected novel/re-emerging infective etiological agent
Key exclusion criteria (1 listed)
- 1. Any person unable to give informed consent and for whom no legally acceptable representative is available
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Detecting of Novel Pathogens
Time frame: Day 1 - Day 28 of recruitment
1. Clinical data collection through case records, and interview of patients or next-of-kin or friend in the event information is unavailable or incompletely documented in the case records. 2. Sample collection will be performed according to the following frequency: 1. First day of enrolment: blood draw (by weight) not more than 20ml, nasal (and/or nasopharyngeal ) and/or throat swab, stool and urine sample. 2. On days 2, 3, 5, 7, 10, 14 and 28: blood (by weight) not more than 10 ml, nasal (and/or nasopharyngeal l) and/or throat swab, stool and urine sample. On D28, blood (by weight) not more than 20ml, will be drawn as most immune response changes manifest by then. If available, urine and stool sample will be collected. If the subject is intubated, endotracheal aspirate will replace nasal and throat swab. Sample collection for research will be done at the same time as samples for clinical testing as far as possible, to minimize patient discomfort.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2017.
- Individual participant dataSharing planned: Undecided
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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.
Tan Ban Hock principal investigator
Singapore General Hospital
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 Prospective Studies, run by Singapore General Hospital at 1 site in Singapore.
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: status not confirmed, as of the sponsor's last update on 6 Oct 2017. 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 Singapore. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detecting of Novel Pathogens (time frame: Day 1 - Day 28 of recruitment). 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 6 Oct 2017.