Singapore Neurologic Infections Program

Central Nervous System Infections Clinical Trial

— SNIP  

Official title:

Singapore Neurologic Infections Program

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02017665
• Other study ID #: 2013/374/E
• Status: Active, not recruiting
• Phase: N/A
• First received: November 4, 2013
• Last updated: April 25, 2017
• Start date: October 2013
• Est. completion date: December 2017

Study information

• Verified date: April 2017
• Source: Singapore General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 400
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Central Nervous System Infections
• Communicable Diseases
• Infection

Locations

Country	Name	City	State
Singapore	Singapore General Hospital	Singapore

Sponsors (6)

Lead Sponsor	Collaborator
Singapore General Hospital	Changi General Hospital, Duke-NUS Graduate Medical School, Khoo Teck Puat Hospital, National University Health System, Singapore, Tan Tock Seng Hospital

Country where clinical trial is conducted

Singapore, 

Outcome

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