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[Clinical evaluation of cefixime in pediatric respiratory tract infections]
1Department of Pediatrics, Meitetsu Hospital.
Insights
Cefixime (CFIX) demonstrates high clinical efficacy and safety in treating pediatric respiratory tract infections, including those caused by Haemophilus influenzae. This antibiotic achieved excellent results with minimal side effects in a large cohort of children.
Area of Science:
- Pediatric Infectious Diseases
- Pharmacology
- Microbiology
Background:
- Pediatric respiratory tract infections (RTIs) pose a significant health challenge.
- Haemophilus influenzae is a common causative agent in pediatric RTIs.
- Evaluating effective and safe antibiotic treatments is crucial for this population.
Purpose of the Study:
- To assess the clinical efficacy and safety of Cefixime (CFIX) in pediatric patients with RTIs.
- To specifically evaluate CFIX's effectiveness against infections caused by Haemophilus influenzae, including beta-lactamase producing strains.
- To determine the bacteriological eradication rates and safety profile of CFIX.
Main Methods:
- A clinical study involving 232 pediatric patients with RTIs.
- CFIX administered at a daily dosage of 3-6 mg/kg/day, divided into 2-3 doses for 3-15 days.
- Clinical efficacy evaluated in 215 cases, safety in 224 cases, and bacteriological effects in 164 identified strains.
- Minimum Inhibitory Concentrations (MICs) were determined for key pathogens.
Main Results:
- Overall clinical efficacy was 93.0% (excellent/good in 95.3% of cases).
- High efficacy rates were observed against H. influenzae (99.1%) and its beta-lactamase producing strains (96.9%).
- Bacteriological eradication rates were high (91.4% overall), with excellent rates for H. influenzae (89.5%) and S. pyogenes (100%).
- CFIX showed potent activity against H. influenzae with MICs ≤0.10 µg/ml, superior to cefaclor and amoxicillin.
- Adverse events were minimal, with only one case of loose stool and one of diarrhea reported.
Conclusions:
- Cefixime (CFIX) is confirmed as an excellent and safe therapeutic option for pediatric respiratory tract infections.
- CFIX demonstrates high clinical and bacteriological efficacy, particularly against Haemophilus influenzae.
- The favorable safety profile supports its use in pediatric patients with RTIs.
Abstract:
Cefixime (CFIX) was evaluated clinically in pediatric respiratory tract infections, particularly those caused by Haemophilus influenzae: 1. The total number of children in this study treated with CFIX was 232, out of which 215 cases were evaluated for clinical efficacy and 224 cases were investigated for safety. A daily dosage of 3-6 mg/kg/day was given divided into 2 to 3 times daily for 3-15 days. 2. Causative organisms were identified in 146 cases, out of which 128 cases were found to be single microbial infections and 18 cases were mixed infections. In single microbial infections, clinical efficacy was 100% for those caused by H. influenzae/Haemophilus parainfluenzae, and was 95% for Streptococcus pyogenes with an overall efficacy of 96.9%. In mixed infections, the clinical efficacy was 100% for those caused by a combination of H. influenzae and Streptococcus pneumoniae, and the overall rate was 94.4%. An involvement of H. influenzae was observed in 108 cases with a clinical efficacy rate of 99.1%, and definite involvement of beta-lactamase secreting strains of H. influenzae was found in 32 cases with a clinical efficacy of 96.9%. 3. Bacteriological effect was studied for 164 strains identified in 146 cases, and eradication rates were 89.5% for H. influenzae, 100% for H. parainfluenzae and S. pyogenes, and 71.4% for S. pneumoniae. The overall eradication rate was 91.4%. Superinfection was observed in 21 cases. MICs against 78 strains of H. influenzae were in a range of less than or equal to 0.10 microgram/ml regardless of beta-lactamase production, and far superior to cefaclor and amoxicillin. MICs against S. pyogenes and S. pneumoniae were in ranges of less than or equal to 0.10 microgram/ml and 0.39 micrograms/ml, respectively. 4. Clinical efficacy was 93.0% in 215 cases (excellent: 136, good: 64, fairly good: 10, poor: 5). CFIX attained a high efficacy in the range of 89.4-95.7% in acute pharyngitis, acute tonsillitis, acute bronchitis and acute pneumonia. 5. Safety was monitored in 224 cases and there were only one case of loose stool and another of diarrhea as side effects. There were no abnormal findings in 31 cases of the laboratory test. In conclusion, it was confirmed that CFIX is excellent and safe in the treatment of the respiratory tract infections.