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Amoxycillin/clavulanate versus amoxycillin in recurrent otitis media and therapeutic failure in children
C Stenström1, K Lundgren, L Ingvarsson
1Department of Otolaryngology, General Hospital, Malmö, Sweden.
Insights
Amoxycillin/clavulanate suspension for 7 days and amoxycillin suspension for 10 days showed comparable efficacy in treating children with recurrent otitis media. Both treatments were well-tolerated, with amoxycillin/clavulanate demonstrating superior elimination of Branhamella catarrhalis.
Area of Science:
- Pediatric infectious diseases
- Clinical pharmacology
- Microbiology
Background:
- Recurrent otitis media (middle ear infection) and treatment failure pose significant challenges in pediatric care.
- Phenoxymethyl penicillin is a common first-line treatment, but resistance and recurrence necessitate alternative therapies.
- Amoxycillin and amoxycillin/clavulanate are frequently used antibiotics for bacterial infections.
Purpose of the Study:
- To compare the efficacy and tolerability of amoxycillin/clavulanate suspension (7-day course) versus amoxycillin suspension (10-day course) in children with recurrent otitis media or treatment failure.
- To evaluate the bacteriological eradication rates of common pathogens, including Haemophilus influenzae, Branhamella catarrhalis, and Streptococcus pneumoniae.
Main Methods:
- A double-blind, parallel-group study involving 102 children.
- Participants received either amoxycillin/clavulanate suspension for 7 days or amoxycillin suspension for 10 days.
- Bacterial and clinical investigations were conducted at follow-up visits (10-12 days and ~30 days post-treatment).
Main Results:
- Both treatment regimens achieved high and satisfactory clinical response rates (>90%) at the first follow-up.
- No statistically significant difference in clinical outcomes was observed between the groups at the second follow-up.
- Amoxycillin/clavulanate showed significantly higher eradication rates for Branhamella catarrhalis compared to amoxycillin alone.
Conclusions:
- A 7-day course of amoxycillin/clavulanate is clinically effective and comparable to a 10-day course of amoxycillin for treating recurrent otitis media in children.
- Amoxycillin/clavulanate offers an advantage in eradicating Branhamella catarrhalis, a common pathogen in otitis media.
- Both antibiotic regimens were well-tolerated, indicating favorable safety profiles for pediatric use.
Abstract:
A total of 102 children with recurrent otitis media or therapeutic failure after treatment with phenoxymethyl penicillin were entered into a double-blind study with parallel groups, comparing treatment with amoxycillin/clavulanate suspension (Spektramox) for 7 days with amoxycillin suspension (Imacillin) for 10 days. Bacterial and clinical investigations were performed. A total of 91 patients were evaluated for efficacy at the first follow-up visit (10-12 days after start of treatment). Amoxycillin/clavulanate and amoxycillin showed equally high, satisfactory treatment results, i.e. more than a 90% response. Similarly, there was no statistically significant difference between the treatment groups at the second follow-up visit (about 30 days after start of treatment). Bacteriological cultures from the nasopharynx showed equal distribution of Haemophilus influenzae, Branhamella catarrhalis and Streptococcus pneumoniae between the study groups. Elimination of the initially occurring pathogens was equal in the two study groups with the exception of B. catarrhalis which was eliminated to a significantly higher extent with amoxycillin/clavulanate. Both drugs were well tolerated. In patients with recurrent otitis media or therapeutic failure, treatment with amoxycillin/clavulanate for 7 days results in high, satisfactory clinical effects and is comparable to treatment with amoxycillin for 10 days.