InfectionNCT02278016
Biological Markers for the Diagnosis of Central Nervous System Infective Diseases
An observational study of Infection, run by Xijing Hospital at 1 site in China.
Trial summary
Bacterial meningitis is a potentially life-threatening disease that is associated with substantial neurological morbidity and mortality. Accurate diagnosis is essential to improve outcome and prevent antibiotic overuse. Read more about this study
- Who is it for?
- Ages 13 years and olderHealthy volunteers can take part
- Conditions the study is for
- Infection
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- Aug 2014to Jul 2017
- How long will I take part?
- 1 Year
- 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 13 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: More than 12 years old; meet the clinical diagnostic criteria for the central nervous system infection disease
Who may be able to join
- Aged 13 years or older;
- At least two of the following clinical characteristics:headache, fever, neck stiffness, mental symptoms or consciousness impairment or seizures
- Patients' family signed informed consent.
Who cannot join
- Contraindications to lumbar puncture
- Patients with active malignancy
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Xijing Hospital
Xi'an, Shaanxi, 710032
jiang wen, MD, 029-84771319, jiangwen@fmmu.edu.cn
jiang wen, MD
About this study
Official title: Diagnosis Value of Procalcitonin, Interleukin-6, AgiotensininⅡin the Cerebrospinal Fluid of Patients With Central Nervous System Infective Diseases
Bacterial meningitis is a potentially life-threatening disease that is associated with substantial neurological morbidity and mortality. Accurate diagnosis is essential to improve outcome and prevent antibiotic overuse. Here we try to explore new biological markers for the diagnosis of the central nervous system infection disease.
Read the detailed description
To investigate the diagnosis value of procalcitonin,interleukin-6, agiotensininⅡin the cerebrospinal fluid in the central nervous system infection disease.
- Conditions
- Infection
- Keywords
- procalcitonin, interleukin-6, agiotensininⅡ
- Medical subject headings
- Infections
What is being measured
The primary outcome is the main question the study is designed to answer.
Levels of procalcitonin, interleukin-6, agiotensininⅡ in the serum and cerebrospinal fluid
meet the clinical diagnostic criteria for the central nervous system infection disease, the blood and cerebrospinal fluid samples after onset.
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2014 (estimated)
- Study startAug 2014
- Primary completionJul 2016 (estimated)
- Study completionJul 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InfectionStudies of the same condition, open and under way.
- More trials run by Xijing HospitalThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- jiang wen, MD, Study chair, The Department of Neurology , Xijing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02278016
- Sponsor's protocol ID
- xijing-120
- Status last verified
- Dec 2015
- First submitted
- 27 Oct 2014
- Last updated
- 1 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Li W, Sun X, Yuan F, Gao Q, Ma Y, Jiang Y, Yang X, Yang F, Ma L, Jiang W. Diagnostic Accuracy of Cerebrospinal Fluid Procalcitonin in Bacterial Meningitis Patients with Empiric Antibiotic Pretreatment. J Clin Microbiol. 2017 Apr;55(4):1193-1204. doi: 10.1128/JCM.02018-16. Epub 2017 Feb 8.
PubMed 28179405
Study at a glance
From the registry record, last updated by the sponsor on 1 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnosis Value of Procalcitonin, Interleukin-6, AgiotensininⅡin the Cerebrospinal Fluid of Patients With Central Nervous System Infective Diseases
- ClinicalTrials.gov ID
- NCT02278016
- Acronym / sponsor ID
- xijing-120
- Conditions
- Infection
- Keywords
- procalcitonin, interleukin-6, agiotensininⅡ
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- Jul 2016 (estimated)
- Study completion
- Jul 2017 (estimated)
- First posted
- 29 Oct 2014 (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.
Bacterial meningitis is a potentially life-threatening disease that is associated with substantial neurological morbidity and mortality. Accurate diagnosis is essential to improve outcome and prevent antibiotic overuse. Here we try to explore new biological markers for the diagnosis of the central nervous system infection disease.
Detailed description
To investigate the diagnosis value of procalcitonin,interleukin-6, agiotensininⅡin the cerebrospinal fluid in the central nervous system infection disease.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- More than 12 years old; meet the clinical diagnostic criteria for the central nervous system infection disease
Key inclusion criteria (3 listed)
- Aged 13 years or older;
- At least two of the following clinical characteristics:headache, fever, neck stiffness, mental symptoms or consciousness impairment or seizures
- Patients' family signed informed consent.
Key exclusion criteria (2 listed)
- Contraindications to lumbar puncture
- Patients with active malignancy
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
Levels of procalcitonin, interleukin-6, agiotensininⅡ in the serum and cerebrospinal fluid
Time frame: 36 months
meet the clinical diagnostic criteria for the central nervous system infection disease, the blood and cerebrospinal fluid samples after onset.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jan 2016.
- Derived from this study: PubMed 28179405Li W, Sun X, Yuan F, Gao Q, Ma Y, Jiang Y, Yang X, Yang F, Ma L, Jiang W. Diagnostic Accuracy of Cerebrospinal Fluid Procalcitonin in Bacterial Meningitis Patients with Empiric Antibiotic Pretreatment. J Clin Microbiol. 2017 Apr;55(4):1193-1204. doi: 10.1128/JCM.02018-16. Epub 2017 Feb 8.
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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.
jiang wen, MD study chair
The Department of Neurology , Xijing Hospital
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 Infection, run by Xijing Hospital at 1 site in China.
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 3 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 1 Jan 2016. 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 China. 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?
Contact jiang wen, MD (029-84771319, jiangwen@fmmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Levels of procalcitonin, interleukin-6, agiotensininⅡ in the serum and cerebrospinal fluid (time frame: 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02278016, which also lists 1 linked publication.
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 1 Jan 2016.