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Published on: July 24, 2016
[Clinical evaluation of flomoxef in pediatrics and a study on the penetration into cerebrospinal fluid]
1Department of Pediatrics, Kagawa Children Hospital.
Abstract:
The transfer to cerebrospinal fluid of a new oxacephem antibiotic flomoxef (FMOX, 6315-S) and its clinical efficacy against bacterial infections were investigated. 1. In 3 cases of purulent meningitis, cerebrospinal fluid concentrations of FMOX after one shot intravenous injection of 100 mg/kg during the acute stage of infections were 5.12-6.32 micrograms/ml and ratios of FMOX in cerebrospinal fluid in serum were about 5%. During the recovery stage, cerebrospinal fluid concentrations were about 3.8 micrograms/ml and cerebrospinal fluid/serum ratios were about 3.5%. 2. In 1 case of purulent meningitis, the treatment with FMOX was clinically effective but this case was classified as "unevaluable" because other drug was used concomitantly. FMOX was rated effective in other 2 cases of purulent meningitis. Of 9 cases of pneumonia, FMOX was rated very effective in 8 cases and it was rated only effective in the other. Of 4 cases of bronchitis, the drug was rated very effective in 3 cases and only effective in the other. FMOX was rated very effective against 2 cases of tonsillitis, also. 3. As side effects, thrombocytosis was observed in 3 of 20 cases examined. All cases, however, were deemed unrelated to the FMOX treatment and the side effect was only transient as are often found in courses of recovery from infections.
Insights
Flomoxef (FMOX) effectively penetrates cerebrospinal fluid and shows high efficacy against bacterial infections like meningitis, pneumonia, and bronchitis. Thrombocytosis was a transient side effect, unrelated to FMOX treatment.
Area of Science:
- Pharmacology
- Infectious Diseases
- Clinical Microbiology
Background:
- Investigating the penetration of the novel oxacephem antibiotic, flomoxef (FMOX), into the cerebrospinal fluid (CSF).
- Assessing the clinical efficacy of FMOX against various bacterial infections.
Observation:
- CSF concentrations of FMOX ranged from 5.12-6.32 µg/ml during the acute stage of purulent meningitis, with CSF/serum ratios around 5%.
- During recovery from meningitis, CSF concentrations decreased to approximately 3.8 µg/ml, with CSF/serum ratios around 3.5%.
- FMOX demonstrated significant clinical effectiveness in treating purulent meningitis, pneumonia, bronchitis, and tonsillitis.
Findings:
- FMOX exhibits favorable penetration into the cerebrospinal fluid.
- High rates of clinical effectiveness were observed for FMOX in treating bacterial meningitis (2/3 effective), pneumonia (8/9 very effective), bronchitis (3/4 very effective), and tonsillitis (2/2 very effective).
- Transient thrombocytosis was noted in 3 cases but was deemed unrelated to FMOX and transient.
Implications:
- Flomoxef (FMOX) represents a promising therapeutic option for bacterial infections, particularly those involving the central nervous system.
- Further clinical studies may solidify FMOX's role in treating a spectrum of bacterial infections.
- The safety profile, including transient thrombocytosis, appears manageable and not directly attributable to FMOX.

