Singapore Neurologic Infections Program

NCT02017665 | Unknown

• 1 other identifier: 2013/374/E
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

Worldwide, central nervous system infections such as inflammation of brain (encephalitis), inflammation of meninges (meningitis) and sudden onset of weakness of muscles which maybe infectious in origin result in significant illness and death and healthcare costs. Vast majority of central nervous system infections remain without an identifiable cause. There is also concern about new and emerging infections. This study thus intends to fill in the gaps in knowledge with regards to central nervous system infections in Singapore to give a thorough description of burden of causes of central nervous system infections and detection of outbreaks of new pathogens. Patients suspected of central nervous system infection will be recruited from 5 restructured Singapore hospitals and their blood and other clinical specimens will be sent for testing. Patients will also be followed up to assess long term outcomes and socio-economic costs of these infections. This will help clinicians, policymakers and public health officials in estimating financial and societal costs of CNs infections in Singapore.

Conditions

Central Nervous System Infections

Keywords

encephalitis; viral infections; central nervous system

Outcome Measures

Primary Outcomes (1)

• Incidence rate of the various infective etiologies causing CNS infections in Singapore

  Annual rates of the various infective causes from year 2013 to year 2016

  36 months

Secondary Outcomes (4)

• Clinical features of patients with CNS infections in Singapore

  Between D1(day of recruitment)-D180(last day of follow up)

• Clinical characteristics of patients diagnosed with CNS infections: .

  Day1- Day180

• Clinical course of patients with CNS infections,

  Day1-Day180

• Treatment modalities of the CNS infections

  Day 1-Day 180

Eligibility Criteria

• Age: 21 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Any patient admitted to the hospital and who meets clinical case definition will be recruited in the study.

You may qualify if:

• Clinical suspicion for Central Nervous system (CNS) infections, OR
• Any two of the following,
• Fever or history of fever (≥ 38 °C) during the presenting illness
• Seizures of new onset
• Focal neurological deficits
• Cerebrospinal fluid white cell count pleocytosis (\> 4 White blood cells (WBC)/uL)
• Abnormal neuroimaging suggestive of CNS infection.
• Abnormal electroencephalogram (EEG) suggestive of CNS infection
• Depressed or altered level of consciousness, OR
• No alternative aetiology for acute paralysis identified (e.g stroke, trauma, myopathy etc)

You may not qualify if:

• Patient or next of kin unwilling to give consent
• Patients with indwelling ventricular devices such as EVD (external ventricular drain), VP (ventriculo-peritoneal) shunts

Sponsors & Collaborators

• Singapore General Hospital: lead
• Tan Tock Seng Hospital: collaborator
• Duke-NUS Graduate Medical School: collaborator
• Changi General Hospital: collaborator
• Khoo Teck Puat Hospital: collaborator
• National University Health System, Singapore: collaborator

Study Sites (1)

Singapore General Hospital

Singapore, 169608, Singapore

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood, cerebrospinal fluid, throat/nasopharyngeal swabs, urine and rectal swabs or stool samples wil be stored for maximum 10 years.All samples will be de-identified and coded

MeSH Terms

Conditions

Central Nervous System Infections; Encephalitis; Virus Diseases

Condition Hierarchy (Ancestors)

Infections; Central Nervous System Diseases; Nervous System Diseases; Brain Diseases; Neuroinflammatory Diseases

Study Officials

• Limin Wijaya, MD

  SGH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2013
• First Posted: December 23, 2013
• Study Start: October 1, 2013
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: April 27, 2017

Record last verified: 2017-04

Locations

SG (1)