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[Clinical studies of an ampicillin suppository (KS-R1) in children]
Insights
KS-R1 demonstrated high clinical effectiveness in pediatric infections, showing success in 27 of 28 cases. This antibiotic was well-tolerated, with minimal adverse effects observed during the trials.
Area of Science:
- Pediatric Infectious Diseases
- Pharmacology
- Clinical Microbiology
Background:
- Bacterial infections in children pose a significant public health challenge.
- Effective antimicrobial agents are crucial for managing pediatric infections.
- Limited data exists on the efficacy of novel antibiotics like KS-R1 in pediatric populations.
Purpose of the Study:
- To evaluate the clinical efficacy and safety of KS-R1 in treating various pediatric infections.
- To assess the in vitro antimicrobial activity of KS-R1 against common bacterial pathogens.
- To determine the bacteriological eradication rates associated with KS-R1 treatment.
Main Methods:
- A clinical trial involving 28 pediatric patients with diverse infections (pharyngitis, tonsillitis, UTIs, etc.).
- Administration of KS-R1 at dosages of 30-50 mg/kg/day.
- In vitro susceptibility testing using ABPC sensitivity discs for isolated organisms.
Main Results:
- KS-R1 achieved clinical effectiveness in 27 out of 28 infections.
- Common pathogens included E. coli, S. pyogenes, and S. pneumoniae.
- High in vitro sensitivity to ABPC was observed for most isolates; bacteriological eradication occurred in 11 patients.
- Only one patient reported a mild adverse effect (pollakiuria).
Conclusions:
- KS-R1 is a clinically effective and well-tolerated antibiotic for treating a range of pediatric bacterial infections.
- The in vitro data supports KS-R1's broad-spectrum activity against common pediatric pathogens.
- Further investigation into KS-R1's efficacy and safety profile is warranted.
Abstract:
Clinical trials of KS-R1 have been carried out on 28 infections in children, including 8 pharyngitis, 11 tonsillitis, a pharyngolaryngobronchitis, 3 lymphadenitis and 5 urinary tract infections. The following results were obtained. KS-R1 30-50 mg/kg/day, was clinically effective in 27 out of 28 infections. Bacteriologically, the following routine clinical isolates were identified; Enterococci in 1 case, S. viridans 1 case, S. pneumoniae 1 case, S. pyogenes 2 cases, H. parainfluenzae 1 case, E. coli 5 cases and S. aureus + H. influenzae 1 case. Every isolated organism showed +++ sensitivity to the ABPC sensitivity disc in vitro without only 1 case of E. coli. The organisms were eradicated in 11 patients after the administration of KS-R1. Adverse effects did not occur in any patient without case 25, who complained of pollakiuria.