Amoxicillin-clavulanate potassium compared with cefaclor for acute otitis media in infants and children
Insights
Amoxicillin-clavulanate potassium and cefaclor showed similar efficacy in treating acute otitis media (OM) in children. While amoxicillin-clavulanate potassium had more gastrointestinal side effects, both treatments resulted in comparable recurrence rates for middle ear disease.
Area of Science:
- Pediatrics
- Infectious Diseases
- Pharmacology
Background:
- Acute otitis media (OM) is a common childhood infection.
- Beta-lactamase-producing bacteria can complicate OM treatment.
- Evaluating antibiotic efficacy and recurrence is crucial for pediatric care.
Purpose of the Study:
- To compare the efficacy of amoxicillin-clavulanate potassium versus cefaclor in treating acute otitis media in infants and children.
- To assess recurrence rates and adverse effects associated with each antibiotic.
Main Methods:
- A randomized trial involving 133 infants and children with documented acute otitis media.
- Participants received either oral amoxicillin-clavulanate potassium or cefaclor.
- Follow-up assessments occurred at multiple time points and upon recurrence of symptoms.
Main Results:
- Both amoxicillin-clavulanate potassium and cefaclor demonstrated high initial resolution rates for otalgia/otorrhea.
- No significant differences were observed in the resolution of otitis media with effusion between the two groups.
- Recurrence rates of acute OM/otorrhea were similar, with approximately 50% recurrence in subjects with or without middle ear effusion at 10 days.
- Amoxicillin-clavulanate potassium was associated with a significantly higher incidence of mild, primarily gastrointestinal, adverse effects.
Conclusions:
- Amoxicillin-clavulanate potassium and cefaclor are comparable in treating acute otitis media in children.
- Parents and clinicians should be aware of the higher likelihood of gastrointestinal side effects with amoxicillin-clavulanate potassium.
- Middle ear effusion status at 10 days did not predict recurrence rates, suggesting a need for continued monitoring post-treatment.
Abstract:
One hundred thirty-three infants and children with documented acute otitis media (OM) were randomized to receive the oral suspension of either amoxicillin-clavulanate potassium or cefaclor. Beta-lactamase-producing bacteria were found in 10.9 and 14.5% of subjects treated with amoxicillin-clavulanate potassium and cefaclor, respectively. Subjects were reexamined at 5, 10, 30, 60 and 90 days after the initiation of therapy and whenever signs/symptoms of acute otitis media recurred. All but two children had resolution of otalgia/otorrhea during the initial treatment period. The drug groups were not significantly different in the percentage of evaluable subjects with otitis media with effusion at each scheduled follow-up visit. Recurrence of acute OM/otorrhea [corrected] developed in a similar percentage of subjects in both treatment categories. Both subjects with and those without middle ear effusion at 10 days had approximately a 50% recurrence rate of subsequent middle ear disease. Adverse side effects/complaints, which occurred in significantly more children treated with amoxicillin-clavulanate potassium, were generally mild and primarily gastrointestinal.
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Acute Pharyngitis
Acute pharyngitis is the inflammation of the back of the throat (pharynx), commonly resulting in a sore throat. It is a frequently encountered condition that prompts individuals to seek medical advice.
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Drug Dosing: Infants and Children
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