Bacterial MeningitisNCT02467309
Vitamin d Levels in Children With Bacterial Meningitis
An observational study of Bacterial Meningitis, run by Gang Liu.
Trial summary
The purpose of this study is to determine whether deficiency of Vitamin D has association with outcomes of children with bacterial meningitis. Read more about this study
- Who is it for?
- Ages 1 month to 18 years
- Conditions the study is for
- Bacterial Meningitis
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- May 2015to Jun 2016
- 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 1 month to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: patients who are diagnosed with bacterial meningitis in infectious diseases department of Beijing Children's Hospital
Who may be able to join
- Probable bacterial meningitis patients: Clinical manifestation (Any person with sudden onset of fever (> 38.5 °C rectal or 38.0 °C axillary) and one of the following signs: neck stiffness, altered consciousness or other meningeal sign) with cerebrospinal fluid examination showing at least one of the following:
- turbid appearance; B.leukocytosis (> 100 cells/mm3); C.leukocytosis (10-100 cells/ mm3) AND either an elevated protein (> 100 mg/dl) or decreased glucose (< 40 mg/dl)
- Confirmed bacterial meningitis patients: A case that is laboratory-confirmed by growing (i.e. culturing) or identifying (i.e. by Gram stain or antigen detection methods) a bacterial pathogen (Hib, pneumococcus or meningococcus) in the cerebrospinal fluid or from the blood in a child with a clinical syndrome consistent with bacterial meningitis
Who cannot join
- Congenital immunodeficiency patients
- HIV patients
- Patients with corticosteroid treatment for long time
- Patients with disorders in adrenal gland and pituitary gland and hypothalamus
- Patients with tuberculosis
About this study
Official title: Association of Serum 25-hydroxyvitamin D Levels and Outcomes in Children With Bacterial Meningitis
The purpose of this study is to determine whether deficiency of Vitamin D has association with outcomes of children with bacterial meningitis.
Read the detailed description
Vitamin D deficiency has been proved in serious diseases patients, including patients in shock, however, few study have been done about association between deficiency of Vitamin D and outcomes of children with bacterial meningitis.
in our study, we will observe incidence of complication and severity of complication between patients who have different Vitamin D status.
- Conditions
- Bacterial Meningitis
- Medical subject headings
- Meningitis, Bacterial
What is being measured
The primary outcome is the main question the study is designed to answer.
vitamin d level change
Serum vitamin d level will be detected in the first day of hospitalization and twenty-eighth day of hospitalization, no vitamin d supplementation during this time
Measured: change in serum vitamin d level from baseline to 28 days after initial hospitalization
Secondary outcomes (12)
Clinical assessment of disease severity with Glasgow score
Disease severity will be assessed with Glasgow score in the first day of hospitalization
Measured: 1 day
Clinical assessment of disease severity with Glasgow score
Disease severity will be assessed with Glasgow score in the seventh day of hospitalization
Measured: 7 day
Clinical assessment of disease severity with Glasgow score
Disease severity will be assessed with Glasgow score in the twenty-eighth day of hospitalization
Measured: 28 day
Clinical assessment of disease severity with pediatric critical illness score
Disease severity will be assessed with pediatric critical illness score in the first day of hospitalization
Measured: 1 day
Clinical assessment of disease severity with pediatric critical illness score
Disease severity will be assessed with pediatric critical illness score in the seventh day of hospitalization
Measured: 7 day
Clinical assessment of disease severity with pediatric critical illness score
Disease severity will be assessed with pediatric critical illness score in the twenty-eighth day of hospitalization
Measured: 28 day
Clinical assessment of disease severity with cerebrospinal fluid examination
Cerebrospinal fluid examination including white blood cell count, protein concentration and glucose concentration in cerebrospinal fluid
Measured: 1 day
Clinical assessment of disease severity with cerebrospinal fluid examination
Cerebrospinal fluid examination including white blood cell count, protein concentration and glucose concentration in cerebrospinal fluid
Measured: 7 day
Clinical assessment of disease severity with cerebrospinal fluid examination
Cerebrospinal fluid examination including white blood cell count, protein concentration and glucose concentration in cerebrospinal fluid
Measured: 28 day
Assessment of complications
Assessment of complications include whether patients have complications, which kind of complication patients suffered, and whether needing surgical therapy.
Measured: 1 day
Assessment of complications
Assessment of complications include whether patients have complications, which kind of complication patients suffered, and whether needing surgical therapy.
Measured: 7 day
Assessment of complications
Assessment of complications include whether patients have complications, which kind of complication patients suffered, and whether needing surgical therapy.
Measured: 28 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2015 (estimated)
- Study startMay 2015
- Primary completionMay 2016 (estimated)
- Study completionJun 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bacterial MeningitisStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gang Liu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Gang Liu, Beijing Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02467309
- Sponsor's protocol ID
- 20150203
- Status last verified
- May 2015
- First submitted
- 18 Mar 2015
- Last updated
- 10 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of Serum 25-hydroxyvitamin D Levels and Outcomes in Children With Bacterial Meningitis
- ClinicalTrials.gov ID
- NCT02467309
- Acronym / sponsor ID
- 20150203
- Conditions
- Bacterial Meningitis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Gang LiuUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- May 2016 (estimated)
- Study completion
- Jun 2016 (estimated)
- First posted
- 10 Jun 2015 (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.
The purpose of this study is to determine whether deficiency of Vitamin D has association with outcomes of children with bacterial meningitis.
Detailed description
Vitamin D deficiency has been proved in serious diseases patients, including patients in shock, however, few study have been done about association between deficiency of Vitamin D and outcomes of children with bacterial meningitis.
in our study, we will observe incidence of complication and severity of complication between patients who have different Vitamin D status.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 month to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- patients who are diagnosed with bacterial meningitis in infectious diseases department of Beijing Children's Hospital
Key inclusion criteria (3 listed)
- Probable bacterial meningitis patients: Clinical manifestation (Any person with sudden onset of fever (> 38.5 °C rectal or 38.0 °C axillary) and one of the following signs: neck stiffness, altered consciousness or other meningeal sign) with cerebrospinal fluid examination showing at least one of the following:
- turbid appearance; B.leukocytosis (> 100 cells/mm3); C.leukocytosis (10-100 cells/ mm3) AND either an elevated protein (> 100 mg/dl) or decreased glucose (< 40 mg/dl)
- Confirmed bacterial meningitis patients: A case that is laboratory-confirmed by growing (i.e. culturing) or identifying (i.e. by Gram stain or antigen detection methods) a bacterial pathogen (Hib, pneumococcus or meningococcus) in the cerebrospinal fluid or from the blood in a child with a clinical syndrome consistent with bacterial meningitis
Key exclusion criteria (5 listed)
- Congenital immunodeficiency patients
- HIV patients
- Patients with corticosteroid treatment for long time
- Patients with disorders in adrenal gland and pituitary gland and hypothalamus
- Patients with tuberculosis
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
vitamin d level change
Time frame: change in serum vitamin d level from baseline to 28 days after initial hospitalization
Serum vitamin d level will be detected in the first day of hospitalization and twenty-eighth day of hospitalization, no vitamin d supplementation during this time
12 secondary outcomes
Clinical assessment of disease severity with Glasgow score
Time frame: 1 day
Clinical assessment of disease severity with Glasgow score
Time frame: 7 day
Clinical assessment of disease severity with Glasgow score
Time frame: 28 day
Clinical assessment of disease severity with pediatric critical illness score
Time frame: 1 day
Clinical assessment of disease severity with pediatric critical illness score
Time frame: 7 day
Clinical assessment of disease severity with pediatric critical illness score
Time frame: 28 day
Clinical assessment of disease severity with cerebrospinal fluid examination
Time frame: 1 day
Clinical assessment of disease severity with cerebrospinal fluid examination
Time frame: 7 day
Clinical assessment of disease severity with cerebrospinal fluid examination
Time frame: 28 day
Assessment of complications
Time frame: 1 day
Assessment of complications
Time frame: 7 day
Assessment of complications
Time frame: 28 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Bacterial Meningitis, run by Gang Liu.
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 5 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 10 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
vitamin d level change (time frame: change in serum vitamin d level from baseline to 28 days after initial hospitalization). 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 10 Jun 2015.