Meropenem Penetration Across BBB in Patients With CNS Infection and Optimization of Meropenem Treatment

• ClinicalTrials.gov Identifier: NCT02506686
• Recruitment Status: Completed
• First Posted: July 23, 2015
• Last Update Posted: July 23, 2015
• Sponsor: Huashan Hospital
• Information provided by (Responsible Party): Jufang Wu, Huashan Hospital

Tracking Information

• First Submitted Date: July 17, 2015
• First Posted Date: July 23, 2015
• Last Update Posted Date: July 23, 2015
• Study Start Date: September 2008
• Actual Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: July 21, 2015)

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

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Meropenem Penetration Across BBB in Patients With CNS Infection and Optimization of Meropenem Treatment
• Official Title: Evaluation of Meropenem Penetration Across Blood-Brain Barrier in Patients With Central Nervous System Infection After Neurosurgery and Optimization of Meropenem Treatment
• 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).
• 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 Type: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Central Nervous System Infections

Intervention

Drug: Meropenem

Meropenem i.v.

Other Name: Mero

Study Arms

Experimental: Meropenem

Meropenem i.v.

Intervention: Drug: Meropenem

• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: July 21, 2015): 82
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: December 2009
• Actual Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT02506686
• Other Study ID Numbers: MERO0001
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Jufang Wu, Huashan Hospital
• Original Responsible Party: Same as current
• Current Study Sponsor: Huashan Hospital
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Jufang Wu, MD; Huashan Hospital

• PRS Account: Huashan Hospital
• Verification Date: July 2015