Related Experiment Videos
[Clinical evaluation of sulbactam/ampicillin in children]
Insights
This study shows Sulbactam/Ampicillin (SBT/ABPC) is a highly effective antibiotic for pediatric bacterial infections, with a 100% efficacy rate and good safety profile. Pharmacokinetic data supports its utility in children.
Area of Science:
- Pediatric Infectious Diseases
- Pharmacology
- Microbiology
Background:
- Sulbactam/Ampicillin (SBT/ABPC) is a combination antibiotic with a fixed 2:1 ratio of ampicillin and sulbactam, an irreversible beta-lactamase inhibitor.
- Bacterial infections in pediatric patients often involve beta-lactamase-producing organisms, necessitating effective treatment options.
Observation:
- A pharmacokinetic study in children aged 5 months to 12 years showed mean half-lives of 48.9 minutes for SBT and 40.2 minutes for ABPC.
- Urinary excretion rates in the first 6 hours were 67.1% for SBT and 48.3% for ABPC.
- Clinical evaluation in 24 pediatric patients with various bacterial infections demonstrated a 100% efficacy rate, with 17 patients showing excellent response and 7 showing good response.
Findings:
- SBT/ABPC exhibited excellent bactericidal activity against both beta-lactamase producing and non-producing Gram-positive and negative bacteria.
- Minimum inhibitory concentrations (MICs) were low against common pathogens like Staphylococcus aureus, Branhamella catarrhalis, and Haemophilus parainfluenzae.
- The antibiotic was well-tolerated, with only minor adverse events like transient eosinophilia and elevated liver enzymes observed in a small number of patients.
Implications:
- Sulbactam/Ampicillin (SBT/ABPC) is a valuable and safe antibiotic option for treating bacterial infections in pediatric populations.
- The pharmacokinetic profile and demonstrated efficacy support its use in various pediatric infections, including bronchopneumonia and urinary tract infections.
- Further research may explore optimal dosing strategies and long-term outcomes in pediatric patients.
Abstract:
Sulbactam/Ampicillin (SBT/ABPC), a combination at a fixed ratio of ABPC and SBT which is an irreversible inhibitor of beta-lactamase in a 2:1 ratio, was clinically evaluated for its efficacy and safety in 24 patients with ages from 5 month-old to 12 years old with bacterial infection. The results obtained are summarized as follows. 1. A pharmacokinetic study following 30 mg/kg SBT/ABPC administration by 30 minutes drip infusion or intravenous bolus injection showed that mean half-lives of SBT and ABPC were 48.9 minutes and 40.2 minutes, respectively, and mean urinary excretion rates of SBT and ABPC in the first 6 hours were 67.1% and 48.3%, respectively. 2. SBT/ABPC was administered to 14 patients with bronchopneumonia, 4 patients with tonsillitis, a patient each with acute upper respiratory infection, with submandibular lymphadenitis, with phlegmon, with enterocolitis, with pyelonephritis and with cystitis at a daily dosage of 88.2-133.3 mg/kg, divided into 3 or 4, by intravenous bolus injection or by 30 minutes drip infusion. Clinical responses of the 24 patients were as follows: excellent: 17 patients, good: 7 patients. The efficacy rate was 100%. 3. Neither clinical adverse reactions nor abnormal laboratory test values, except slight eosinophilia in a patient and an elevation of GOT, GPT in another were observed. 4. MICs of SBT/ABPC against 7 strong beta-lactamase producing strains isolated from some of the patients were as follows. MIC against a strain of Staphylococcus aureus was 3.13 micrograms/ml, MICs against 2 out of 5 strains of Branhamella catarrhalis were 0.10 microgram/ml and those of the remaining 3 strains were 0.20 microgram/ml. MIC against a strain of Haemophilus parainfluenzae was 3.13 micrograms/ml. 5. These data described above show that SBT/ABPC has excellent bactericidal capacity against beta-lactamase producing bacteria as well as beta-lactamase non-producing Gram-positive and negative bacteria and suggest that SBT/ABPC is a very useful antibiotic for pediatric patients.