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[Experimental and clinical studies on BRL 25000 (clavulanic acid-amoxicillin) in the pediatric field]
Insights
BRL 25000, a combination of amoxicillin and clavulanic acid, demonstrates enhanced efficacy against beta-lactamase producing bacteria in pediatric infections. Clinical trials show an 87% efficacy rate, highlighting its effectiveness in treating various bacterial conditions.
Area of Science:
- Microbiology
- Pharmacology
- Pediatrics
Context:
- Bacterial infections in children require effective antibiotic treatment.
- Beta-lactamase producing bacteria pose a significant challenge to standard antibiotic therapies.
- Amoxicillin alone is often inactivated by bacterial beta-lactamase enzymes.
Purpose:
- To evaluate the in vitro and in vivo efficacy of BRL 25000 (amoxicillin/clavulanic acid) in pediatric patients.
- To assess the antimicrobial activity of BRL 25000 against clinically relevant bacterial strains, including beta-lactamase producers.
- To determine the pharmacokinetic profile and clinical outcomes of BRL 25000 in children with bacterial infections.
Summary:
- BRL 25000 exhibited potent in vitro activity against beta-lactamase producing strains of Staphylococcus aureus, Escherichia coli, Klebsiella pneumoniae, and Haemophilus influenzae, showing significantly lower MIC80 values compared to amoxicillin alone.
- Pharmacokinetic studies in children revealed favorable absorption, distribution, and excretion profiles for both amoxicillin and clavulanic acid following oral administration of BRL 25000 granules.
- Clinical studies involving 23 pediatric patients demonstrated an overall efficacy rate of 87.0% for BRL 25000 in treating diverse bacterial infections, with a notable 88.9% efficacy in cases involving beta-lactamase producing organisms.
Impact:
- BRL 25000 represents a valuable therapeutic option for pediatric bacterial infections, particularly those caused by resistant strains.
- The combination of amoxicillin and clavulanic acid in BRL 25000 effectively overcomes beta-lactamase mediated resistance.
- This study supports the use of BRL 25000 in pediatric practice, offering improved treatment outcomes and addressing the challenge of antibiotic resistance.
Abstract:
Fundamental and clinical studies on BRL 25000 granules were carried out in the pediatric field. BRL 25000 is a formulation comprising 1 part of clavulanic acid (CVA) and 2 parts of amoxicillin (AMPC). The MICs of BRL 25000 and AMPC were assessed against 24 clinically isolated strains of S. aureus (including 23 beta-lactamase producing strains), 22 S. pyogenes, 20 E. coli (8 beta-lactamase producing strains), 24 K. pneumoniae (24 beta-lactamase producing strains), 20 H. influenzae (6 beta-lactamase producing strains). BRL 25000 showed MIC80 (cumulatively 80% of strains were inhibited) at 6.25 micrograms/ml against S. aureus, less than or equal to 0.10 micrograms/ml against inst S. pyogenes, 12.5 micrograms/ml against E. coli, 6.25 micrograms/ml against K. pneumoniae and 0.39 micrograms/ml against H. influenzae. BRL 25000 showed no improvement in MIC terms against beta-lactamase nonproducing strains compared with AMPC. However, BRL 25000 was markedly more effective against beta-lactamase producing strains. Thus BRL 25000 was up to 8 fold more active against S. aureus, 2 to 64 fold against E. coli, 4 to 128 fold against K. pneumoniae, 4 to 16 fold against H. influenzae than AMPC. Following oral administration of BRL 25000 granules (at a dose level of 12.5 mg/kg) to 2 children aged 9 and 11 years, the mean peak serum concentrations of AMPC and CVA were 8.33 +/- 2.43 micrograms/ml and 4.44 +/- 1.65 micrograms/ml respectively 1 hour after dosing. The half-lives of AMPC and CVA were 1.35 +/- 0.42 hours and 0.91 +/- 0.05 hour, respectively. The urinary excretion was 48.21 +/- 3.83% for AMPC and 16.90 +/- 7.06% for CVA in the first 6 hours after administration. In clinical studies, 23 pediatric patients aged 2 months to 12 years with bacterial infections were treated with BRL 25000 granules and the clinical effectiveness, bacteriological response and side effects were evaluated. The clinical response was assessed in 23 cases, 3 with acute rhinitis, 6 with acute purulent tonsillitis, 5 with acute bronchitis, 4 with acute pneumonia, 3 with impetigo, 1 with furunculosis and 1 with periproctal abscess. Results were excellent in 13 cases, good in 7, fair in 3 and hence the efficacy rate (excellent and good cases) was 87.0% (20/23). In particular the clinical response in 9 cases with infections due to beta-lactamase producing organisms was excellent in 6, good in 2, fair in 1 and the efficacy rate was 88.9% (8/9).(ABSTRACT TRUNCATED AT 400 WORDS)