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Quantitative comparison of adverse reactions to cefaclor vs. amoxicillin in a surveillance study
Insights
Cefaclor and amoxicillin showed similar overall adverse event rates in children with recurrent bacterial infections. However, cefaclor was associated with more serum sickness-like reactions and urticaria.
Area of Science:
- Pediatric Infectious Diseases
- Pharmacovigilance
- Bacterial Infections Treatment
Background:
- Recurrent bacterial infections in children necessitate effective and safe treatment options.
- Antibiotic surveillance is crucial for identifying and characterizing adverse events.
- Cefaclor and amoxicillin are commonly prescribed antibiotics for pediatric bacterial infections.
Purpose of the Study:
- To prospectively compare the incidence and nature of adverse events associated with cefaclor and amoxicillin in children.
- To evaluate the safety profile of cefaclor versus amoxicillin in a pediatric population with recurrent bacterial infections.
Main Methods:
- An 18-month prospective surveillance study involving children aged 1 month to 16 years.
- Patients received either cefaclor or amoxicillin for suspected or proven bacterial infections.
- Adverse events were monitored via telephone during therapy and for 2 weeks post-therapy.
Main Results:
- Overall adverse event rates were comparable: 5.7% for cefaclor and 5.2% for amoxicillin.
- Cefaclor use was linked to a higher incidence of serum sickness-like reactions (1.1%) and urticaria.
- Gastrointestinal events and other adverse experiences were similarly distributed between the two antibiotic groups.
Conclusions:
- While both cefaclor and amoxicillin demonstrate similar overall safety profiles, specific adverse reactions like serum sickness-like reactions and urticaria are more frequent with cefaclor.
- Clinicians should consider these differential adverse event profiles when prescribing antibiotics for pediatric recurrent bacterial infections.
Abstract:
During an 18-month adverse events surveillance period, children with a history of recurrent suspected or proved bacterial infections were treated with either cefaclor (1017 patients, 2513 courses) or amoxicillin (1009 patients, 2358 courses) and followed prospectively to determine the relative incidence and character of adverse events. Patients were from 1 month to 16 years old. Otitis media, the principal diagnosis, occurred in 883 patients (2014 episodes) receiving cefaclor and in 856 (1888 episodes) receiving amoxicillin. Others were diagnosed as having pharyngitis (482 episodes), bronchitis (267 episodes), sinusitis (130 episodes), pneumonia (63 episodes) and urinary tract infection (27 episodes). Adverse events were elicited by telephone during therapy and by follow-up for 2 weeks after therapy and were reported in 5.7% of the cefaclor courses and 5.2% of courses of amoxicillin. Serum sickness-like reactions and erythema multiforme occurred in 5 and 6 children, respectively, given cefaclor (1.1%) and in no children given amoxicillin. Children in the cefaclor group had a greater incidence of urticaria. Other adverse experiences, including gastrointestinal events, were approximately equally distributed for the two groups.