Clinical Trial: Singapore Neurologic Infections Program

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Observational [Patient Registry]

Official Title: Singapore Neurologic Infections Program

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.


Detailed Summary:

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.


Sponsor: Singapore General Hospital

Current Primary Outcome: Incidence rate of the various infective etiologies causing CNS infections in Singapore [ Time Frame: 36 months ]

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


Original Primary Outcome: Incidence rate of the various infective etiologies causing CNS infections in Singapore [ Time Frame: 24 months ]

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


Current Secondary Outcome:

  • Clinical features of patients with CNS infections in Singapore [ Time Frame: Between D1(day of recruitment)-D180(last day of follow up) ]
  • Clinical characteristics of patients diagnosed with CNS infections: . [ Time Frame: Day1- Day180 ]
    gender, presenting symptoms, duration between symptoms to diagnosis etc
  • Clinical course of patients with CNS infections, [ Time Frame: Day1-Day180 ]
    development of any complications and their long term outcomes/prognosis
  • Treatment modalities of the CNS infections [ Time Frame: Day 1-Day 180 ]


Original Secondary Outcome: Same as current

Information By: Singapore General Hospital

Dates:
Date Received: November 4, 2013
Date Started: October 2013
Date Completion: December 2017
Last Updated: April 25, 2017
Last Verified: April 2017