Central Nervous System InfectionsPhase 4NCT02506686
Meropenem Penetration Across BBB in Patients With CNS Infection and Optimization of Meropenem Treatment
A Phase 4 study testing Meropenem in people with Central Nervous System Infections, run by Huashan Hospital.
Trial summary
A prospective, open-label study investigated the pharmacokinetic profile of meropenem in patients with post-neurosurgical central nervous system (CNS) infection, especially its BBB penetration into cerebrospinal fluid (CSF). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Central Nervous System Infections
- What is being tested?
- Meropenem
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- No sites listed yet
- Study dates
- Sep 2008to Dec 2009
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- at least 18 years of age
- requiring continuous drainage of CSF or gram-negative bacteria were identified from CSF culture
- have temperature fever (T > 37.5℃)
- have signs of meningeal irritation
- white blood cells in CSF > 300 × 10^6/L
Who cannot join
- hypersensitive to meropenem
- did not receive at least 3 days of meropenem treatment
- are receiving hemodialysis
- unstable vital signs
- have lumbar puncture contraindications and so inappropriate for sample collection
- severe hepatic or renal dysfunction
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- status epilepticus
- potential neurodegenerative diseases
- pregnancy
- breast-feeding
About this study
Official title: Evaluation of Meropenem Penetration Across Blood-Brain Barrier in Patients With Central Nervous System Infection After Neurosurgery and Optimization of Meropenem Treatment
A prospective, open-label study investigated the pharmacokinetic profile of meropenem in patients with post-neurosurgical central nervous system (CNS) infection, especially its BBB penetration into cerebrospinal fluid (CSF).
Read the detailed description
Meropenem is important for management of post-neurosurgical meningitis, but the data about its penetration across blood-brain barrier (BBB) are inadequate. This prospective, open-label study investigated the pharmacokinetic profile of meropenem in patients with post-neurosurgical central nervous system (CNS) infection, especially its BBB penetration into cerebrospinal fluid (CSF). A total of 82 patients with post-neurosurgical CNS infection were included to receive meropenem intravenously according to regimen of 2g q8h, 1g q8h or 1g q6h. After infusion of 4 doses, blood and CSF samples were collected simultaneously at predefined timepoints. High-performance liquid chromatography ultraviolet method was used to determine the concentration of meropenem.
- Conditions
- Central Nervous System Infections
- Being tested
- Meropenem
- Medical subject headings
- Central Nervous System Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MeropenemDrug
Also called Mero
Meropenem i.v.
| Study group | Role | What they receive |
|---|---|---|
| Meropenem | Experimental | Meropenem i.v. Receives: Drug: Meropenem |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentrations of meropenem in plasma and CSF in patients with CNS Infections
The concentrations of meropenem in plasma and CSF in patients with post-neurosurgical CNS after administration of three different dosing regimens of meropenem at each time points by HPLC-UV
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2015 (estimated)
- Study startSep 2008
- Primary completionDec 2009
- Study completionDec 2009
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 Central Nervous System InfectionsStudies of the same condition, open and under way.
- More trials run by Huashan 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Huashan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jufang Wu, Huashan Hospital
- Investigators
- Jufang Wu, MD, Principal investigator, Huashan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02506686
- Sponsor's protocol ID
- MERO0001
- Status last verified
- Jul 2015
- First submitted
- 17 Jul 2015
- Last updated
- 23 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Lu C, Zhang Y, Chen M, Zhong P, Chen Y, Yu J, Wu X, Wu J, Zhang J. Population Pharmacokinetics and Dosing Regimen Optimization of Meropenem in Cerebrospinal Fluid and Plasma in Patients with Meningitis after Neurosurgery. Antimicrob Agents Chemother. 2016 Oct 21;60(11):6619-6625. doi: 10.1128/AAC.00997-16. Print 2016 Nov.
PubMed 27572392
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Meropenem Penetration Across Blood-Brain Barrier in Patients With Central Nervous System Infection After Neurosurgery and Optimization of Meropenem Treatment
- ClinicalTrials.gov ID
- NCT02506686
- Acronym / sponsor ID
- MERO0001
- Conditions
- Central Nervous System Infections
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Huashan HospitalUniversity, hospital or other
- Study start
- Sep 2008
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 23 Jul 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.
A prospective, open-label study investigated the pharmacokinetic profile of meropenem in patients with post-neurosurgical central nervous system (CNS) infection, especially its BBB penetration into cerebrospinal fluid (CSF).
Detailed description
Meropenem is important for management of post-neurosurgical meningitis, but the data about its penetration across blood-brain barrier (BBB) are inadequate. This prospective, open-label study investigated the pharmacokinetic profile of meropenem in patients with post-neurosurgical central nervous system (CNS) infection, especially its BBB penetration into cerebrospinal fluid (CSF). A total of 82 patients with post-neurosurgical CNS infection were included to receive meropenem intravenously according to regimen of 2g q8h, 1g q8h or 1g q6h. After infusion of 4 doses, blood and CSF samples were collected simultaneously at predefined timepoints. High-performance liquid chromatography ultraviolet method was used to determine the concentration of meropenem.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Meropenem | Experimental | Drug: MeropenemMeropenem i.v. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- at least 18 years of age
- requiring continuous drainage of CSF or gram-negative bacteria were identified from CSF culture
- have temperature fever (T > 37.5℃)
- have signs of meningeal irritation
- white blood cells in CSF > 300 × 10^6/L
Key exclusion criteria (10 listed)
- hypersensitive to meropenem
- did not receive at least 3 days of meropenem treatment
- are receiving hemodialysis
- unstable vital signs
- have lumbar puncture contraindications and so inappropriate for sample collection
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 |
|---|---|---|
| MeropenemAlso: MeroMeropenem i.v. | Drug | Meropenem |
Primary outcome
Concentrations of meropenem in plasma and CSF in patients with CNS Infections
Time frame: Up to 12 months
The concentrations of meropenem in plasma and CSF in patients with post-neurosurgical CNS after administration of three different dosing regimens of meropenem at each time points by HPLC-UV
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 23 Jul 2015.
- Derived from this study: PubMed 27572392Lu C, Zhang Y, Chen M, Zhong P, Chen Y, Yu J, Wu X, Wu J, Zhang J. Population Pharmacokinetics and Dosing Regimen Optimization of Meropenem in Cerebrospinal Fluid and Plasma in Patients with Meningitis after Neurosurgery. Antimicrob Agents Chemother. 2016 Oct 21;60(11):6619-6625. doi: 10.1128/AAC.00997-16. Print 2016 Nov.
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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.
Jufang Wu, MD principal investigator
Huashan Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Meropenem in people with Central Nervous System Infections, run by Huashan 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 5 inclusion and 10 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 23 Jul 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 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 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?
Concentrations of meropenem in plasma and CSF in patients with CNS Infections (time frame: Up to 12 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 NCT02506686, 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 23 Jul 2015.