Central Nervous System InfectionsSNIPNCT02017665
Singapore Neurologic Infections Program
An observational study of Central Nervous System Infections, run by Singapore General Hospital at 1 site in Singapore.
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. Read more about this study
- Who is it for?
- Ages 21 to 100 years
- Conditions the study is for
- Central Nervous System Infections
- How many people
- 400 participants
- Where
- 1 siteSingapore
- Study dates
- Oct 2013to Dec 2017
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Any patient admitted to the hospital and who meets clinical case definition will be recruited in the study.
Who may be able to join
- 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)
Show all 10Show fewer
- 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)
Who cannot join
- Patient or next of kin unwilling to give consent
- Patients with indwelling ventricular devices such as EVD (external ventricular drain), VP (ventriculo-peritoneal) shunts
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
The study aims to:
- To describe the epidemiology of CNS infections in Singapore.
- To improve the diagnosis of aetiologies of CNS infections through a systematic clinical, laboratory and neuro-radiological evaluation and extensive diagnostic testing.
- To evaluate the prognosis, long-term outcomes and socio-economic costs of CNS infections.
- 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.
- Conditions
- Central Nervous System Infections
- Keywords
- encephalitis, viral infections, central nervous system
- Medical subject headings
- Central Nervous System Infections, Encephalitis, Virus Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 36 months
Secondary outcomes (4)
Clinical features of patients with CNS infections in Singapore
Measured: Between D1(day of recruitment)-D180(last day of follow up)
Clinical characteristics of patients diagnosed with CNS infections: .
gender, presenting symptoms, duration between symptoms to diagnosis etc
Measured: Day1- Day180
Clinical course of patients with CNS infections,
development of any complications and their long term outcomes/prognosis
Measured: Day1-Day180
Treatment modalities of the CNS infections
Measured: Day 1-Day 180
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2013 (estimated)
- Study startOct 2013
- Primary completionDec 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Central Nervous System InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Singapore General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Tan Tock Seng Hospital, Duke-NUS Graduate Medical School, Changi General Hospital, Khoo Teck Puat Hospital, National University Health System, Singapore
- Responsible party
- Sponsor
- Investigators
- Limin Wijaya, MD, Principal investigator, SGH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02017665
- Sponsor's protocol ID
- 2013/374/E
- Acronym
- SNIP
- Status last verified
- Apr 2017
- First submitted
- 4 Nov 2013
- Last updated
- 27 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Singapore Neurologic Infections Program
- ClinicalTrials.gov ID
- NCT02017665
- Acronym / sponsor ID
- SNIP / 2013/374/E
- Conditions
- Central Nervous System Infections
- Keywords
- encephalitis, viral infections, central nervous system
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Singapore General HospitalUniversity, hospital or other
- Collaborators
- Tan Tock Seng Hospital, Duke-NUS Graduate Medical School, Changi General Hospital, Khoo Teck Puat Hospital, National University Health System, Singapore
- Study start
- Oct 2013
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 23 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 description
The study aims to:
- To describe the epidemiology of CNS infections in Singapore.
- To improve the diagnosis of aetiologies of CNS infections through a systematic clinical, laboratory and neuro-radiological evaluation and extensive diagnostic testing.
- To evaluate the prognosis, long-term outcomes and socio-economic costs of CNS infections.
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
Who may qualify
- Ages
- 21 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Any patient admitted to the hospital and who meets clinical case definition will be recruited in the study.
Key inclusion criteria (10 listed)
- Clinical suspicion for Central Nervous system (CNS) infections, OR
- Any two of the following,
- No alternative aetiology for acute paralysis identified (e.g stroke, trauma, myopathy etc)
Key exclusion criteria (2 listed)
- Patient or next of kin unwilling to give consent
- Patients with indwelling ventricular devices such as EVD (external ventricular drain), VP (ventriculo-peritoneal) shunts
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
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
4 secondary outcomes
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
Clinical course of patients with CNS infections,
Time frame: Day1-Day180
Treatment modalities of the CNS infections
Time frame: Day 1-Day 180
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Limin Wijaya, MD principal investigator
SGH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Central Nervous System Infections, run by Singapore General Hospital at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence rate of the various infective etiologies causing CNS infections in Singapore (time frame: 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2017; AzTrials last refreshed its copy on 27 Oct 2026.