Bacterial Meningitis Clinical Trial
Official title:
Population Pharmacokinetics of Commonly Used Antimicrobial Agents in Children of Bacterial Meningitis With Augmented Renal Clearance
The investigator's purpose is to study the population pharmacokinetics of commonly used antimicrobial agents in children of bacterial meningitis with augmented renal clearance and assess dosage individualization feasibility.
Status | Recruiting |
Enrollment | 300 |
Est. completion date | March 20, 2026 |
Est. primary completion date | January 20, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 2 Months to 18 Years |
Eligibility | Inclusion Criteria: - Children have been diagnosed with bacterial meningitis with augmented renal clearance (eGFR = 160 mL/(min*1.73m2)); - Age: 2 months-18 years; - Meropenem, vancomycin, ceftazidime, ceftriaxone, ceftizoxime and/ or linezolid used as part of regular treatment; - Meropenem, vancomycin, ceftazidime, ceftriaxone, ceftizoxime and linezolid was administered intravenously. Exclusion Criteria: - Patients who die within the treatment cycle; - Severe congenital malformation; - Receive other systemic experimental drug therapy; - Other factors that the researchers consider unsuitable for inclusion. |
Country | Name | City | State |
---|---|---|---|
China | Children's Hospital of Chongqing Medical University | Chongqing | Chongqing |
Lead Sponsor | Collaborator |
---|---|
Shandong University | Children's Hospital of Chongqing Medical University |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The peak plasma and cerebrospinal fluid drug concentration of meropenem,vancomycin,ceftazidime,ceftriaxone,ceftizoxime,linezolid. | To detect the peak plasma and cerebrospinal fluid drug concentration of meropenem,vancomycin,ceftazidime,ceftriaxone,ceftizoxime,linezolid after intravenous administration. | at (5-10) minutes after intravenous administration | |
Primary | The random plasma and cerebrospinal fluid drug concentration of meropenem,vancomycin,ceftazidime,ceftriaxone,ceftizoxime,linezolid. | To detect the random plasma and cerebrospinal fluid drug concentration of meropenem,vancomycin,ceftazidime,ceftriaxone,ceftizoxime,linezolid after intravenous administration. | at (0.5-10) hours after intravenous administration | |
Primary | The trough plasma and cerebrospinal fluid drug concentration of meropenem,vancomycin,ceftazidime,ceftriaxone,ceftizoxime,linezolid. | To detect the trough plasma and cerebrospinal fluid drug concentration of meropenem,vancomycin,ceftazidime,ceftriaxone,ceftizoxime,linezolid after intravenous administration. | at 1-2 hours before the next administration | |
Secondary | clinical response | Blood routine examination, cerebrospinal fluid routine examination and infection indicators (C-reaction protein, procalcitonin) | Through study completion, an average of 14 days |
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