Meropenem Penetration Across BBB in Patients With CNS Infection and Optimization of Meropenem Treatment
Evaluation of Meropenem Penetration Across Blood-Brain Barrier in Patients With Central Nervous System Infection After Neurosurgery and Optimization of Meropenem Treatment
1 other identifier
interventional
82
0 countries
N/A
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Sep 2008
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2009
CompletedFirst Submitted
Initial submission to the registry
July 17, 2015
CompletedFirst Posted
Study publicly available on registry
July 23, 2015
CompletedJuly 23, 2015
July 1, 2015
1.2 years
July 17, 2015
July 21, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
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
Up to 12 months
Study Arms (1)
Meropenem
EXPERIMENTALMeropenem i.v.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- status epilepticus
- potential neurodegenerative diseases
- pregnancy
- breast-feeding
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Huashan Hospitallead
Related Publications (1)
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.
PMID: 27572392DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jufang Wu, MD
Huashan Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
July 17, 2015
First Posted
July 23, 2015
Study Start
September 1, 2008
Primary Completion
December 1, 2009
Study Completion
December 1, 2009
Last Updated
July 23, 2015
Record last verified: 2015-07