Detect Novel Pathogens and Characterize Emerging Infections

NCT01979705 | Unknown

• 1 other identifier: NP 07/2013
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Prospective Studies

Outcome Measures

Primary Outcomes (1)

• Detecting of Novel Pathogens

  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.

  Day 1 - Day 28 of recruitment

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Any person admitted to Singapore General Hospital or seen as an outpatient in the Specialist Outpatient Clinic who has:
• \. clinical history and/or clinical syndromes compatible with a suspected novel/re-emerging infective etiological agent

You may not qualify if:

• \. Any person unable to give informed consent and for whom no legally acceptable representative is available

Sponsors & Collaborators

• Singapore General Hospital: lead

Study Sites (1)

Singapore General Hospital

Singapore, 168751, Singapore

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

1. Blood 2. Throat Swab 3. Nasal Swab 4. ETT Swab (if patient is intubated) 5. Urine 6. Stool

Study Officials

• Tan Ban Hock

  Singapore General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 30, 2013
• First Posted: November 8, 2013
• Study Start: August 1, 2013
• Primary Completion: January 1, 2020
• Study Completion: June 1, 2020
• Last Updated: October 6, 2017

Record last verified: 2017-10

Locations

SG (1)