Ignite Creation Date:
2025-12-25 @ 3:18 AM
Ignite Modification Date:
2026-03-05 @ 12:07 AM
Study NCT ID:
NCT01979705
Status:
UNKNOWN
Last Update Posted:
2017-10-06
First Post:
2013-10-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Detect Novel Pathogens and Characterize Emerging Infections
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': '1. Blood\n2. Throat Swab\n3. Nasal Swab\n4. ETT Swab (if patient is intubated)\n5. Urine\n6. Stool'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-10', 'completionDateStruct': {'date': '2020-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-10-05', 'studyFirstSubmitDate': '2013-10-30', 'studyFirstSubmitQcDate': '2013-11-03', 'lastUpdatePostDateStruct': {'date': '2017-10-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-11-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Detecting of Novel Pathogens', 'timeFrame': 'Day 1 - Day 28 of recruitment', 'description': '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.\n2. Sample collection will be performed according to the following frequency:\n\n 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.\n 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.\n\nIf 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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Prospective Studies']}, 'descriptionModule': {'briefSummary': "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.\n\nBecause 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.\n\nOn 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.\n\nWhat 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.\n\nSome 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.", 'detailedDescription': 'This study has the following aims:\n\n1. To detect novel, previously undescribed pathogens.\n2. 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;\n3. To characterize immune responses to such viruses in patients.\n4. To archive specimens with no identifiable infectious etiological agents for future testing.\n\nA 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.\n\nNovel 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.\n\nIn 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'This is a prospective study with inclusion criteria as specified below:\n\nInclusion criteria:\n\nAny person admitted to Singapore General Hospital or seen as an outpatient in the Specialist Outpatient Clinic who has:\n\n1\\. clinical history and/or clinical syndromes compatible with a suspected novel/re-emerging infective etiological agent.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAny person admitted to Singapore General Hospital or seen as an outpatient in the Specialist Outpatient Clinic who has:\n\n1\\. clinical history and/or clinical syndromes compatible with a suspected novel/re-emerging infective etiological agent\n\nExclusion Criteria:\n\n1\\. Any person unable to give informed consent and for whom no legally acceptable representative is available'}, 'identificationModule': {'nctId': 'NCT01979705', 'acronym': 'NP', 'briefTitle': 'Detect Novel Pathogens and Characterize Emerging Infections', 'organization': {'class': 'OTHER', 'fullName': 'Singapore General Hospital'}, 'officialTitle': 'A Prospective Study to Detect Novel Pathogens and Characterize Emerging Infections', 'orgStudyIdInfo': {'id': 'NP 07/2013'}}, 'contactsLocationsModule': {'locations': [{'zip': '168751', 'city': 'Singapore', 'status': 'RECRUITING', 'country': 'Singapore', 'contacts': [{'name': 'Sabariah Mortar', 'role': 'CONTACT', 'email': 'sabariah.mohamed.mortar@sgh.com.sg', 'phone': '+65 6321 3479'}, {'name': 'Tan Ban Hock', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Singapore General Hospital', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}], 'overallOfficials': [{'name': 'Tan Ban Hock', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Singapore General Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Singapore General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}