Trial record 6 of 16 for:    Meningitis and Encephalitis

Singapore Neurologic Infections Program (SNIP)

This study is currently recruiting participants.
Verified December 2013 by Singapore General Hospital
Sponsor:
Collaborators:
Tan Tock Seng Hospital
Duke-NUS Graduate Medical School
Changi General Hospital
Khoo Teck Puat Hospital
National University Health System, Singapore
Information provided by (Responsible Party):
Singapore General Hospital
ClinicalTrials.gov Identifier:
NCT02017665
First received: November 4, 2013
Last updated: December 16, 2013
Last verified: December 2013
  Purpose

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.


Condition
Central Nervous System Infections

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 6 Months
Official Title: Singapore Neurologic Infections Program

Resource links provided by NLM:


Further study details as provided by Singapore General Hospital:

Primary Outcome Measures:
  • Incidence rate of the various infective etiologies causing CNS infections in Singapore [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Annual rates of the various infective causes from year 2013 to year 2016


Secondary Outcome Measures:
  • Clinical features of patients with CNS infections in Singapore [ Time Frame: Between D1(day of recruitment)-D180(last day of follow up) ] [ Designated as safety issue: No ]
  • Clinical characteristics of patients diagnosed with CNS infections: . [ Time Frame: Day1- Day180 ] [ Designated as safety issue: No ]
    gender, presenting symptoms, duration between symptoms to diagnosis etc

  • Clinical course of patients with CNS infections, [ Time Frame: Day1-Day180 ] [ Designated as safety issue: No ]
    development of any complications and their long term outcomes/prognosis

  • Treatment modalities of the CNS infections [ Time Frame: Day 1-Day 180 ] [ Designated as safety issue: No ]

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


Estimated Enrollment: 400
Study Start Date: October 2013
Estimated Study Completion Date: April 2016
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Detailed Description:

The study aims to:

  1. To describe the epidemiology of CNS infections in Singapore.
  2. To improve the diagnosis of aetiologies of CNS infections through a systematic clinical, laboratory and neuro-radiological evaluation and extensive diagnostic testing.
  3. To evaluate the prognosis, long-term outcomes and socio-economic costs of CNS infections.
  4. To establish an archive of biological tissues from patients with encephalitis and CNS infections that can be utilized for future testing for emerging novel pathogens or non-infectious aetiologies.

The study will recruit 400 patients over 2 years from 5 restructured hospitals in Singapore. As this is not a comparative study, sample size was not determined.

The study involves clinical and laboratory data collection. Data will also be collected on quality of life and for health economic analysis. The quality of data and its integrity will be periodically reviewed by the Principal Investigator and members of the study team. All samples stored will be de-identified and all data will be de-identified during analysis.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

Inclusion Criteria:

  1. Clinical suspicion for Central Nervous system (CNS) infections, OR
  2. Any two of the following,

    1. Fever or history of fever (≥ 38 °C) during the presenting illness
    2. Seizures of new onset
    3. Focal neurological deficits
    4. Cerebrospinal fluid white cell count pleocytosis (> 4 White blood cells (WBC)/uL)
    5. Abnormal neuroimaging suggestive of CNS infection.
    6. Abnormal electroencephalogram (EEG) suggestive of CNS infection
    7. Depressed or altered level of consciousness, OR
  3. No alternative aetiology for acute paralysis identified (e.g stroke, trauma, myopathy etc)

Exclusion Criteria:

  1. Patient or next of kin unwilling to give consent
  2. Patients with indwelling ventricular devices such as EVD (external ventricular drain), VP (ventriculo-peritoneal) shunts
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT02017665

Locations
Singapore
Singapore General Hospital Recruiting
Singapore, Singapore, 169608
Contact: Limin Wijaya, MD    +65 6321 3479    limin.wijaya@sgh.com.sg   
Contact: Hui Zhen Sam, Bachelor    +65 6321 3479    sam.hui.zhen@sgh.com.sg   
Principal Investigator: Limin Wijaya, MD         
Sponsors and Collaborators
Singapore General Hospital
Tan Tock Seng Hospital
Duke-NUS Graduate Medical School
Changi General Hospital
Khoo Teck Puat Hospital
National University Health System, Singapore
Investigators
Principal Investigator: Limin Wijaya, MD SGH
  More Information

No publications provided

Responsible Party: Singapore General Hospital
ClinicalTrials.gov Identifier: NCT02017665     History of Changes
Other Study ID Numbers: 2013/374/E
Study First Received: November 4, 2013
Last Updated: December 16, 2013
Health Authority: Singapore: Institutional Review Board

Keywords provided by Singapore General Hospital:
encephalitis
viral infections
central nervous system

Additional relevant MeSH terms:
Central Nervous System Infections
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on April 22, 2014