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[Laboratory and clinical studies of T-1982 (cefbuperazone in pediatric field]
Abstract:
The authors have carried out the laboratory and clinical studies of T-1982 (cefbuperazone). The results were as follows: The sensitivity was estimated by the plate dilution method on 28 strains of S. aureus 26 strains of E. coli, 27 strains of K. pneumoniae, 25 strains of S. marcescens and 14 strains of Proteus sp. isolated from patients. The distribution of susceptibility of S. aureus was 1.25-25 micrograms/ml and the peak of distribution was 12.5 micrograms/ml. The strains of 84.6% of E. coli were inhibited at concentration of less than 0.39 micrograms/ml. The strains of 77.8% of K. pneumoniae were inhibited at concentration of less than 0.2 microgram/ml. The strains of 96% of S. marcescens was inhibited at concentration of less than 3.13 micrograms/ml. The distribution of susceptibility of Proteus sp. was 0.39-25 micrograms/ml. T-1982 was given to intravenous administration for 5 minutes and drip infusion for 30 minutes a single dose of 20 mg/kg of T-1982 to 2 and 2 children respectively. After intravenous administration of T-1982, the mean serum level was peak 88.4 +/- 8.7 micrograms/ml at 15 minutes, 52.5 +/- 2.7 micrograms/ml at 1 hour, 4.6 +/- 0.15 micrograms/ml at 6 hours respectively. Half-life was 89 minutes. And after drip infusion of T-1982, the mean serum level was 75.5 +/- 3.5 micrograms/ml at 30 minutes and 3.1 +/- 0.6 micrograms/ml at 6.5 hours respectively. Half-life was 82 minutes. The mean urinary excretion rate was 94.7%, 57.4 +/- 11.0% up to 6 hours after intravenous administration and drip infusion respectively. T-1982 was effective in 13 cases out of 13 cases with bacterial infections. No side effects were observed except for 1 case with elevation of serum GOT, 1 case with elevation of serum GPT and 2 cases with eosinophilia.
Insights
Laboratory and clinical studies show T-1982 (cefbuperazone) is effective against bacterial infections. This antibiotic demonstrated significant in vitro activity and favorable pharmacokinetics in pediatric patients, with minimal adverse effects observed.
Area of Science:
- Pharmacology
- Microbiology
- Clinical Pharmacy
Background:
- Bacterial infections pose a significant global health challenge.
- The development of novel antimicrobial agents is crucial for combating resistant pathogens.
- Cefbuperazone (T-1982) is an investigational antibiotic evaluated for its efficacy and safety.
Purpose of the Study:
- To assess the in vitro antimicrobial activity of T-1982 against common bacterial pathogens.
- To determine the pharmacokinetic profile of T-1982 following intravenous and drip infusion administration in pediatric patients.
- To evaluate the clinical efficacy and safety of T-1982 in treating bacterial infections.
Main Methods:
- In vitro susceptibility testing using the plate dilution method on clinical isolates including S. aureus, E. coli, K. pneumoniae, S. marcescens, and Proteus sp.
- Pharmacokinetic analysis of T-1982 serum levels and urinary excretion rates after single intravenous (IV) and drip infusion doses in pediatric subjects.
- Clinical evaluation of T-1982 efficacy and adverse events in patients with diagnosed bacterial infections.
Main Results:
- T-1982 exhibited potent in vitro activity, with high susceptibility rates observed for E. coli, K. pneumoniae, and S. marcescens at low concentrations.
- Pharmacokinetic studies revealed a rapid absorption and elimination profile, with half-lives of 89 minutes (IV) and 82 minutes (drip infusion).
- T-1982 demonstrated 100% clinical efficacy in treating 13 cases of bacterial infections, with only minor, transient elevations in liver enzymes and eosinophilia reported as adverse events.
Conclusions:
- T-1982 possesses broad-spectrum antibacterial activity and favorable pharmacokinetic properties suitable for clinical use.
- The antibiotic is effective in treating bacterial infections with a good safety profile in pediatric patients.
- Further clinical trials are warranted to establish T-1982 as a viable therapeutic option.