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Detect Novel Pathogens and Characterize Emerging Infections (NP)

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ClinicalTrials.gov Identifier: NCT01979705
Recruitment Status : Unknown
Verified October 2017 by Singapore General Hospital.
Recruitment status was:  Recruiting
First Posted : November 8, 2013
Last Update Posted : October 6, 2017
Sponsor:
Information provided by (Responsible Party):
Singapore General Hospital

Brief 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. 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.


Condition or disease
Prospective Studies

Detailed Description:

This study has the following aims:

  1. To detect novel, previously undescribed pathogens.
  2. 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;
  3. To characterize immune responses to such viruses in patients.
  4. 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.

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective Study to Detect Novel Pathogens and Characterize Emerging Infections
Actual Study Start Date : August 2013
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : June 2020



Primary Outcome Measures :
  1. 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.



Biospecimen Retention:   Samples With DNA
  1. Blood
  2. Throat Swab
  3. Nasal Swab
  4. ETT Swab (if patient is intubated)
  5. Urine
  6. Stool


Information from the National Library of Medicine

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.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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.

Criteria

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


Information from the National Library of Medicine

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): NCT01979705


Locations
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Singapore
Singapore General Hospital Recruiting
Singapore, Singapore, 168751
Contact: Sabariah Mortar    +65 6321 3479    sabariah.mohamed.mortar@sgh.com.sg   
Principal Investigator: Tan Ban Hock         
Sponsors and Collaborators
Singapore General Hospital
Investigators
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Principal Investigator: Tan Ban Hock Singapore General Hospital
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Responsible Party: Singapore General Hospital
ClinicalTrials.gov Identifier: NCT01979705    
Other Study ID Numbers: NP 07/2013
First Posted: November 8, 2013    Key Record Dates
Last Update Posted: October 6, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Infection