- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01979705
Detect Novel Pathogens and Characterize Emerging Infections (NP)
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.
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.
Study Overview
Status
Conditions
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 Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
-
-
-
Singapore, Singapore, 168751
- Recruiting
- Singapore General Hospital
-
Contact:
- Sabariah Mortar
- Phone Number: +65 6321 3479
- Email: sabariah.mohamed.mortar@sgh.com.sg
-
Principal Investigator:
- Tan Ban Hock
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
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.
Description
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
Exclusion Criteria:
1. Any person unable to give informed consent and for whom no legally acceptable representative is available
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Detecting of Novel Pathogens
Time Frame: Day 1 - Day 28 of recruitment
|
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. |
Day 1 - Day 28 of recruitment
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Tan Ban Hock, Singapore General Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NP 07/2013
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Prospective Studies
-
Joacim StalforsKarolinska Institutet; Linkoeping University; Sahlgrenska University Hospital... and other collaboratorsUnknownPostoperative Complications | Tonsillectomy | Prospective Studies | RegistriesSweden
-
Peking University Third HospitalCompletedAdolescent | Myopia | Female | Adult | Male | Preoperative Period | Lens Implantation, Intraocular | Tomography, Optical Coherence | Postoperative Period | Human | Prospective Studies | Follow-up Studies | Phakic Intraocular Lenses | Retinal VesselsChina
-
University of Cape TownUniversity of Stellenbosch; University of KwaZuluNot yet recruitingIron Deficiency Anemia | Anaemia | Iron | Prospective Studies | Paediatric Surgery | Interventional Studies
-
The Cleveland ClinicTerminatedHeart Failure | Prospective StudiesUnited States
-
University of KwaZuluUniversity of Cape Town; African Perioperative Research Group (APORG); Safe Surgery...CompletedSurgery | Perioperative/Postoperative Complications | Perioperative Outcomes | Outcome Assessment | Prospective Studies | Paediatrics | Hospital Mortality | Paediatric Surgery | Developing CountriesSouth Africa, Sudan
-
Beijing Friendship HospitalPeking University People's Hospital; Peking Union Medical College Hospital; Peking... and other collaboratorsRecruitingRectal Cancer | Colonic Cancer | Prospective StudiesChina
-
Sahlgrenska University Hospital, SwedenStryker NordicRecruiting
-
University Hospital, Clermont-FerrandRecruitingUltrasonography | Airway Extubation | Predictive Value of Tests | Critical Care | Ventilator Weaning | Echocardiography, Transthoracic | Mechanical Ventilator Weaning | Prospective Studies | Area Under Curve | Care Unit, Intensive | Sensitivity and Specificity | Logistic Models | Biomarkers / BloodFrance
-
Mette Røn KristensenUnknownCerebral Palsy | Child | Hip Dislocation | Radiography | Prospective Studies | Hip DisplacementDenmark
-
Wuhan Union Hospital, ChinaRenmin Hospital of Wuhan University; Beijing Tsinghua Changgeng HospitalCompleted