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A single-center, open-label, parallel-randomized, controlled clinical study: the study of glycopeptide drugs in cerebrospial fluid of patients following craniotomy

The pharmacokinetics study of norvancomycin in cerebrospial fluid of patients following craniotomy

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000028928
Enrollment
Unknown
Registered
2020-01-08
Start date
2020-01-17
Completion date
Unknown
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intracranial infection

Interventions

experimental group:patients received an intrathecal injection of 16mg of NVCM per day and intravenously infused with 800 mg of NVCM, every 12-h
control group:intravenously infused with 800 mg of NVCM, every 12-h

Sponsors

The Second Hospital of Hebei Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. This study included neurosurgical patients with lumbar cistern drainage tubes following the operation who were diagnosed in the Neurosurgery Department of the Second Hospital of Hebei Medical University at the ages between 18 and 70. These patients received a norvancomycin treatment for intracranial infections. 2. The diagnostic criteria for the infections were described as follows: 1) a positive MRSA in the CSF cultures; 2) temperature 38 degree C, headache, vomit, and meningeal irritation signs such as nuchal rigidity, Kernigs sign, and Brudzinskis sign; 3) the following abnormalities in the CSF test: WBC count > 1000 x 10^6 cells/L, CSF glucose 500 mg/L.

Exclusion criteria

Exclusion criteria: The following patients were excluded from this study: 1. those who had undergone an antibiotic therapy against gram-positive bacteria, including MRSA during one week prior to the onset of study; 2. those with histories of dysfunctions in lung, heart, liver (alanine aminotransferase or aspartate aminotransferase > 40 U/L), kidney (endogenous creatinine clearance < 10 mL/min), or other organs; 3. those who were female patients at the perinatal period; 4. those with a record of NVCM or vancomycin allergy; 5. those who failed to sustain spontaneous breathing or were in an agonal condition, or in a deep coma.

Design outcomes

Primary

MeasureTime frame
Drug concentration in cerebrospinal fluid;cure time;Pharmacokinetic data;

Secondary

MeasureTime frame
CSF WBC;CSF glucose;CSF protein;CSF chloride;adverse reaction;White blood cell count in blood;

Countries

China

Contacts

Public ContactYaqian Li

The Second Hospital of Hebei Medical University

304644197@qq.com+86 15131661066

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026