Gram Negative MeningitisPhase 4NCT00362245
Amikacin Penetration Into the Cerebrospinal Fluid
A Phase 4 study testing Systemic and Intra-Thecal Amikacin Therapy in people with Gram Negative Meningitis and Post Traumatic Bacterial Meningitis, run by Rambam Health Care Campus at 1 site in Israel.
Trial summary
The limited available data precludes establishing an antibiotic regimen in patients suffering from bacterial meningitis after head trauma, or spontaneous bleeding Understanding the disposition of Amikacin administered intrathecally will enable to propose rational treatment of these patients. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gram Negative Meningitis, Post Traumatic Bacterial Meningitis
- What is being tested?
- Systemic and Intra-Thecal Amikacin Therapy
- How many people
- 0 participants
- Where
- 1 siteIsrael
- Study dates
- Sep 2006to Nov 2008
- Phase
- Phase 4
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Culture proved bacterial meningitis where the prescribed therapy includes the use of systemic and intraventricular amikacin therapy.
- The included patient should have an intraventricular catheter placed for intraventricular pressure measurement and admitted to an intensive care unit.
- Blood creatinine concentration up to 1.49 mg/dL measured at the inclusion day.
Who cannot join
- Patients or legal guardians who refuse to participate in the study.
- Known allergy to amikacin.
- Blood creatinine concentration of 1.5 mg/dL or higher.
- Subjects without intraventricular catheter who will need repeated lumbar punctures for CSF amikacin determinations.
- Patients suffering from known chronic liver disease.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Amikacin Penetration Into the Cerebrospinal Fluid: Pharmacokinetic/Pharmacodynamic Analysis in Adults With Hospital Acquired Gram-negative Meningitis Associated With Intracranial Pressure Monitoring and Draining Devices
The limited available data precludes establishing an antibiotic regimen in patients suffering from bacterial meningitis after head trauma, or spontaneous bleeding Understanding the disposition of Amikacin administered intrathecally will enable to propose rational treatment of these patients.
Read the detailed description
The limited available data precludes establishing an antibiotic regimen in patients suffering from bacterial meningitis after head trauma, or spontaneous bleeding Understanding the disposition of Amikacin administered intrathecally will enable to propose rational treatment of these patients.
- Being tested
- Systemic and Intra-Thecal Amikacin Therapy
- Keywords
- Amikacin, Pharmacokinetics, Pharmacodynamics, Intra-Thecal injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Systemic and Intra-Thecal Amikacin TherapyDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Bactericidal effect on the causative bacteria
Blood and CSF AUC/MIC relationship
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2006 (estimated)
- Study startSep 2006
- Primary completionNov 2008
- Study completionNov 2008
Why it stopped: lack of participants
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gram Negative 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rambam Health Care Campus
- Sponsor type
- University, hospital or other
- Investigators
- Yedidiah Bentur, MD, Principal investigator, Rambam Health Care Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00362245
- Sponsor's protocol ID
- 07/2006_CTIL
- Status last verified
- Nov 2015
- First submitted
- 8 Aug 2006
- Last updated
- 3 Nov 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Amikacin Penetration Into the Cerebrospinal Fluid: Pharmacokinetic/Pharmacodynamic Analysis in Adults With Hospital Acquired Gram-negative Meningitis Associated With Intracranial Pressure Monitoring and Draining Devices
- ClinicalTrials.gov ID
- NCT00362245
- Acronym / sponsor ID
- 07/2006_CTIL
- Keywords
- Amikacin, Pharmacokinetics, Pharmacodynamics, Intra-Thecal injection
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: lack of participants
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- Study start
- Sep 2006
- Primary completion
- Nov 2008 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 9 Aug 2006 (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 limited available data precludes establishing an antibiotic regimen in patients suffering from bacterial meningitis after head trauma, or spontaneous bleeding Understanding the disposition of Amikacin administered intrathecally will enable to propose rational treatment of these patients.
Detailed description
The limited available data precludes establishing an antibiotic regimen in patients suffering from bacterial meningitis after head trauma, or spontaneous bleeding Understanding the disposition of Amikacin administered intrathecally will enable to propose rational treatment of these patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Culture proved bacterial meningitis where the prescribed therapy includes the use of systemic and intraventricular amikacin therapy.
- The included patient should have an intraventricular catheter placed for intraventricular pressure measurement and admitted to an intensive care unit.
- Blood creatinine concentration up to 1.49 mg/dL measured at the inclusion day.
Key exclusion criteria (5 listed)
- Patients or legal guardians who refuse to participate in the study.
- Known allergy to amikacin.
- Blood creatinine concentration of 1.5 mg/dL or higher.
- Subjects without intraventricular catheter who will need repeated lumbar punctures for CSF amikacin determinations.
- Patients suffering from known chronic liver disease.
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 |
|---|---|---|
| Systemic and Intra-Thecal Amikacin Therapy | Drug | – |
Primary outcome
Bactericidal effect on the causative bacteria
Blood and CSF AUC/MIC relationship
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 3 Nov 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.
Yedidiah Bentur, MD principal investigator
Rambam Health Care Campus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Systemic and Intra-Thecal Amikacin Therapy in people with Gram Negative Meningitis and Post Traumatic Bacterial Meningitis, run by Rambam Health Care Campus at 1 site in Israel.
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: withdrawn, as of the sponsor's last update on 3 Nov 2015. 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 Israel. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Bactericidal effect on the causative bacteria. The study lists 2 primary outcomes in all. 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 3 Nov 2015.