NeurosurgeryPhase 1NCT00925093
Study of Antibiotics in Cerebrospinal Fluid Following Intravenous Injection
A Phase 1 study testing Vancomycin, Teicoplanin and Linezolid in people with Neurosurgery, run by Aarhus University Hospital.
Trial summary
Three different antibiotics are used to prevent infection in case of neurosurgery - this study examines to which extent the antibiotics penetrate from the blood to the cerebrospinal fluid (surrounding the brain). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Neurosurgery
- What is being tested?
- Vancomycin, Teicoplanin and Linezolid
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Sep 2011to Dec 2013
- Phase
- Phase 1
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Over 18 years old
- Already having an external CSF drain
- Scheduled for neurosurgery requiring antibiotic prophylaxis (most commonly placement of an internal drain ("shunt")
Who cannot join
- Infection or colonization requiring other than standard prophylactic antibiotics
About this study
Official title: Antibiotics in Cerebrospinal Fluid Following Intravenous Injection
Three different antibiotics are used to prevent infection in case of neurosurgery - this study examines to which extent the antibiotics penetrate from the blood to the cerebrospinal fluid (surrounding the brain).
- Conditions
- Neurosurgery
- Being tested
- Vancomycin, Teicoplanin, Linezolid
- Keywords
- vancomycin, teicoplanin, linezolid, intravenous, cerebrospinal fluid, CSF, pharmacokinetics, penetration, blood-brain barrier, Pharmacokinetics of three antibiotics in relation to cerebrospinal fluid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VancomycinDrug
Vancomycin is administered intravenously and subsequently measured in cerebrospinal fluid sample
TeicoplaninDrug
Teicoplanin is administered intravenously and subsequently measured in cerebrospinal fluid sample
LinezolidDrug
Linezolid is administered intravenously and subsequently measured in cerebrospinal fluid sample
| Study group | Role | What they receive |
|---|---|---|
| Vancomycin | Active comparator | Vancomycin is administered intravenously and subsequently measured in cerebrospinal fluid sample Receives: Drug: Vancomycin |
| Teicoplanin | Active comparator | Teicoplanin is administered intravenously and subsequently measured in cerebrospinal fluid sample Receives: Drug: Teicoplanin |
| Linezolid | Active comparator | Linezolid is administered intravenously and subsequently measured in cerebrospinal fluid sample Receives: Drug: Linezolid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentration of antibiotics in cerebrospinal fluid
Concentration in CSF past i.v. injection
Measured: 1, 2, 4, 6, 12 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2009 (estimated)
- Study startSep 2011
- Primary completionDec 2012 (estimated)
- Study completionDec 2013 (estimated)
Why it stopped: Primary investigator left institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeurosurgeryStudies 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aarhus University Hospital
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00925093
- Sponsor's protocol ID
- AUH-MGP-AB-CSV-2009-1
- Status last verified
- Jun 2009
- First submitted
- 18 Jun 2009
- Last updated
- 26 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antibiotics in Cerebrospinal Fluid Following Intravenous Injection
- ClinicalTrials.gov ID
- NCT00925093
- Acronym / sponsor ID
- AUH-MGP-AB-CSV-2009-1
- Conditions
- Neurosurgery
- Keywords
- vancomycin, teicoplanin, linezolid, intravenous, cerebrospinal fluid, CSF, pharmacokinetics, penetration
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Primary investigator left institution
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Aarhus University HospitalUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Dec 2012 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 19 Jun 2009 (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.
Three different antibiotics are used to prevent infection in case of neurosurgery - this study examines to which extent the antibiotics penetrate from the blood to the cerebrospinal fluid (surrounding the brain).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Vancomycin | Active comparator | Drug: VancomycinVancomycin is administered intravenously and subsequently measured in cerebrospinal fluid sample |
| Teicoplanin | Active comparator | Drug: TeicoplaninTeicoplanin is administered intravenously and subsequently measured in cerebrospinal fluid sample |
| Linezolid | Active comparator | Drug: LinezolidLinezolid is administered intravenously and subsequently measured in cerebrospinal fluid sample |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Over 18 years old
- Already having an external CSF drain
- Scheduled for neurosurgery requiring antibiotic prophylaxis (most commonly placement of an internal drain ("shunt")
Key exclusion criteria (1 listed)
- Infection or colonization requiring other than standard prophylactic antibiotics
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VancomycinVancomycin is administered intravenously and subsequently measured in cerebrospinal fluid sample | Drug | Vancomycin |
| TeicoplaninTeicoplanin is administered intravenously and subsequently measured in cerebrospinal fluid sample | Drug | Teicoplanin |
| LinezolidLinezolid is administered intravenously and subsequently measured in cerebrospinal fluid sample | Drug | Linezolid |
Primary outcome
Concentration of antibiotics in cerebrospinal fluid
Time frame: 1, 2, 4, 6, 12 hours
Concentration in CSF past i.v. injection
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 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?
A Phase 1 study testing Vancomycin, Teicoplanin and Linezolid in people with Neurosurgery, run by Aarhus University Hospital.
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 1 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: withdrawn, as of the sponsor's last update on 26 Jan 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Concentration of antibiotics in cerebrospinal fluid (time frame: 1, 2, 4, 6, 12 hours). 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 26 Jan 2015.