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[Clinical evaluation of an ampicillin suppository (KS-R1) in infections in children]
Insights
New pediatric ampicillin suppositories (KS-R1) show high efficacy in treating respiratory and urinary tract infections. The treatment was well-tolerated with only mild, transient side effects observed in clinical trials.
Area of Science:
- Pediatric Infectious Diseases
- Pharmacology
- Clinical Therapeutics
Background:
- Ampicillin is a widely used antibiotic for bacterial infections.
- Development of novel drug delivery systems like suppositories can improve patient compliance and therapeutic outcomes, especially in pediatric populations.
- Evaluating new formulations is crucial for optimizing antimicrobial therapy.
Observation:
- A clinical trial was conducted to assess the efficacy and safety of a new ampicillin suppository formulation (KS-R1) in pediatric patients.
- The study included 24 pediatric patients diagnosed with either respiratory tract infections (15 patients) or urinary tract infections (9 patients).
- Patients received KS-R1 at dosages ranging from 31 mg/kg to 75 mg/kg, administered 3 or 4 times daily.
Findings:
- High efficacy rates were observed: 93.3% for respiratory tract infections (8 excellent, 6 good) and 77.8% for urinary tract infections (4 excellent, 3 good).
- Adverse events were minimal and transient, including diarrhea in 4 patients and anal pain in 1 patient.
- No significant abnormal laboratory findings were reported, suggesting a favorable safety profile.
Implications:
- The ampicillin suppository (KS-R1) demonstrates promising therapeutic potential for pediatric respiratory and urinary tract infections.
- This novel formulation may offer a viable alternative for pediatric antibiotic administration, potentially improving adherence.
- Further research could explore its use in other pediatric infections and compare its effectiveness with existing treatments.
Abstract:
The following results were obtained in clinical trials of new ampicillin suppository (KS-R1) in the pediatric infection. Twenty-four patients comprising 15 with respiratory tract infection, 9 with urinary tract infection were received KS-R1 at the dose ranging from 31 mg/kg to 75 mg/kg divided 3 or 4 times a day. The results in the respiratory tract infection were "excellent" in 8 and "good" in 6, and the efficacy rate was 93.3%. The results in the urinary tract infection were "excellent" in 4 and "good" in 3, and the efficacy rate was 77.8%. Diarrhea were observed in 4 patients, and anal pain was observed in 1. But the symptoms were transient. No abnormal laboratory findings were observed.