[Clinical evaluation of a new oral cephalosporin, cefprozil, in pediatrics]
M Woo1, H Higashino, U Kohdera
1Department of Pediatrics, Kansai Medical University.
Insights
Cefprozil (CFPZ) is a new oral cephalosporin antibiotic demonstrating 100% clinical efficacy in pediatric patients with various bacterial infections. It showed stronger antibacterial activity than cefaclor and was well-tolerated.
Area of Science:
- Pharmacology
- Infectious Diseases
- Pediatrics
Background:
- Cefprozil (CFPZ) is a novel oral cephalosporin antibiotic.
- Evaluation of antibacterial activity and clinical efficacy is crucial for new antimicrobial agents.
Purpose of the Study:
- To assess the antibacterial activity and clinical efficacy of Cefprozil (CFPZ).
- To determine the safety and tolerability of Cefprozil (CFPZ) in pediatric patients.
Main Methods:
- A clinical study involving 34 pediatric patients treated with Cefprozil (CFPZ) at doses of 7.7-36.2 mg/kg/day in three divided doses.
- Evaluation of clinical efficacy in 33 patients across various infections including pneumonia, bronchitis, upper respiratory tract infections, urinary tract infections, lymphadenitis, and soft tissue infections.
- Bacteriological response was assessed for identified strains.
Main Results:
- Overall clinical efficacy rate was 100% (8 excellent, 23 good) among evaluable patients.
- Bacteriological eradication was confirmed in 66.7% (6/9) of identified bacterial strains.
- Cefprozil (CFPZ) exhibited superior antibacterial activity compared to cefaclor.
- Adverse events were minimal, observed in only 2 patients (nausea, pallor, increased eosinophils).
Conclusions:
- Cefprozil (CFPZ) is a safe and effective oral antibiotic for treating bacterial infections in pediatric patients.
- The drug demonstrates promising antibacterial potency and a favorable safety profile.
Abstract:
Cefprozil (CFPZ, BMY-28100), a new oral cephalosporin, was evaluated for its antibacterial activity and clinical efficacy. Thirty-four patients were treated with 7.7-36.2 mg/kg per day of CFPZ divided into 3 times. A total of 33 patients including 3 with acute pneumonia, 2 with acute bronchitis, 17 with acute upper respiratory tract infections, 4 with urinary tract infections, 1 with suppurative lymphadenitis and 6 with other soft tissue infections were evaluated for clinical efficacy except for 1 patient whose general conditions were too serious to continue to be treated with orally medication. Clinical effects were excellent in 8 patients and good in 23 but 2 cases were excluded because they were suspected for viral infections, hence the overall efficacy rate was 100%. Bacteriological responses were confirmed on 6 (66.7%) strains which were eradicated by the treatment out of 9 strains identified. CFPZ showed stronger antibacterial activities than those of cefaclor. Side effects or abnormal laboratory test results were observed in 2 patients; nausea and pallor of face in 1 patient and an increase of eosinophil in 1. The above findings suggest that CFPZ is a safe and useful antibiotics for the treatment of bacterial infections in pediatric patients.
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