Intrathecal InfectionNCT02875808
Cerebrospinal Fluid IL-6, IL-8 and PCT as Early Marker of an Intrathecal Infection in Neurosurgical Patients
An observational study of Intrathecal Infection and External Ventricular Drainage Associated Infection, run by University Medicine Greifswald at 1 site in Germany.
Trial summary
The value of CSF IL-6, IL-8 and Procalcitonin in detecting an early diagnosis of intrathecal infection in neurosurgical patients with an external ventricular drainage is evaluated. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Intrathecal Infection, External Ventricular Drainage Associated Infection
- How many people
- 50 participants
- Where
- 1 siteGermany
- Study dates
- 1 Aug 2014to 12 Dec 2017
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: consecutive patients with an external ventricular drainage
Who may be able to join
- external ventricular drainage
- informed consent
Who cannot join
- no informed consent
- prior intrathecal infection
- prior systemic infection / sepsis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Early Detection of CSF Infection in Neurosurgical Patients
The value of CSF IL-6, IL-8 and Procalcitonin in detecting an early diagnosis of intrathecal infection in neurosurgical patients with an external ventricular drainage is evaluated.
Read the detailed description
The value of CSF IL-6, IL-8 and Procalcitonin in detecting an early diagnosis of intrathecal infection in neurosurgical patients with an external ventricular drainage is evaluated.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| patients | patients with an external ventricular drainage |
What is being measured
The primary outcome is the main question the study is designed to answer.
increasing IL-6, IL-8 and PCT prior to an clinically apparent intrathecal infection/ a detection with the goldstandard
Measured: 08/ 2014 - 12/ 2016
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2016 (estimated)
- Study start1 Aug 2014
- Primary completion1 Sep 2016
- Study completion12 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intrathecal InfectionStudies 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
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medicine Greifswald
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sascha Marx, University Medicine Greifswald
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02875808
- Sponsor's protocol ID
- CSF IL-6, IL-8 and PCT
- Status last verified
- Nov 2018
- First submitted
- 18 Aug 2016
- Last updated
- 6 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Detection of CSF Infection in Neurosurgical Patients
- ClinicalTrials.gov ID
- NCT02875808
- Acronym / sponsor ID
- CSF IL-6, IL-8 and PCT
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University Medicine GreifswaldUniversity, hospital or other
- Study start
- 1 Aug 2014 (actual)
- Primary completion
- 1 Sep 2016 (actual)
- Study completion
- 12 Dec 2017 (actual)
- First posted
- 23 Aug 2016 (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 value of CSF IL-6, IL-8 and Procalcitonin in detecting an early diagnosis of intrathecal infection in neurosurgical patients with an external ventricular drainage is evaluated.
Detailed description
The value of CSF IL-6, IL-8 and Procalcitonin in detecting an early diagnosis of intrathecal infection in neurosurgical patients with an external ventricular drainage is evaluated.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients | – | –patients with an external ventricular drainage |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- consecutive patients with an external ventricular drainage
Key inclusion criteria (2 listed)
- external ventricular drainage
- informed consent
Key exclusion criteria (3 listed)
- no informed consent
- prior intrathecal infection
- prior systemic infection / sepsis
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
increasing IL-6, IL-8 and PCT prior to an clinically apparent intrathecal infection/ a detection with the goldstandard
Time frame: 08/ 2014 - 12/ 2016
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2018.
- Individual participant dataSharing planned: Undecided
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.
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 Intrathecal Infection and External Ventricular Drainage Associated Infection, run by University Medicine Greifswald at 1 site in Germany.
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 2 inclusion and 3 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: finished, as of the sponsor's last update on 6 Nov 2018. 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 Germany. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
increasing IL-6, IL-8 and PCT prior to an clinically apparent intrathecal infection/ a detection with the goldstandard (time frame: 08/ 2014 - 12/ 2016). 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 6 Nov 2018.