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Comparative efficacies of erythromycin-sulfisoxazole and cefaclor in acute otitis media: a double blind randomized
Insights
Erythromycin-sulfisoxazole (E/S) and cefaclor showed similar overall clinical outcomes for acute otitis media. However, E/S demonstrated faster otoscopic improvement and superior efficacy in non-bacteriologically confirmed cases.
Area of Science:
- Pediatrics
- Infectious Diseases
- Pharmacology
Background:
- Acute otitis media (AOM) is a common childhood infection.
- Bacterial resistance, including beta-lactamase production in common pathogens like Haemophilus influenzae and Branhamella catarrhalis, poses treatment challenges.
- Evaluating alternative antibiotic regimens is crucial for effective AOM management.
Purpose of the Study:
- To compare the efficacy and safety of erythromycin-sulfisoxazole (E/S) versus cefaclor in treating AOM.
- To assess treatment outcomes based on clinical and bacteriological findings.
Main Methods:
- A prospective, double-blind trial involving 119 children across six Canadian centers.
- Diagnostic tympanocentesis was performed to identify bacterial pathogens.
- Patients were randomized to receive either E/S or cefaclor.
- Clinical outcomes and otoscopic findings were evaluated at 10 and 31 days.
Main Results:
- Common bacterial isolates included Streptococcus pneumoniae, Haemophilus influenzae, and Branhamella catarrhalis.
- A significant proportion of H. influenzae and B. catarrhalis strains were beta-lactamase producers.
- Overall clinical outcomes were similar between E/S and cefaclor groups at 10 and 31 days.
- The E/S group showed more rapid otoscopic improvement (P <= 0.04).
- E/S was significantly more effective in patients with sterile middle ear fluid initially (75% cure vs. 14% for cefaclor, P = 0.02).
- Side effects were infrequent and comparable between treatments.
Conclusions:
- Erythromycin-sulfisoxazole (E/S) is at least as effective as cefaclor for AOM.
- E/S may offer superior outcomes, especially in cases without clear bacterial evidence on initial culture.
- The study highlights the potential role of E/S in managing AOM, considering bacterial resistance patterns.
Abstract:
A prospective double blind trial compared the fixed combination of erythromycin-sulfisoxazole (E/S) with cefaclor in the treatment of acute otitis media. One hundred nineteen children in six centers across Canada were studied. Diagnostic tympanocentesis of 134 ears yielded 135 bacterial isolates: Streptococcus pneumoniae (42%); Haemophilus influenzae (21%); Branhamella catarrhalis (10%); Streptococcus pyogenes (5%); and other bacteria (22%). Seventy-seven percent of strains of B. catarrhalis and 14% of strains of H. influenzae were beta-lactamase producers. E/S exhibited greater in vitro activity against H. influenzae and B. catarrhalis. Twenty-three patients had bacteriologically sterile middle ear fluid. The overall clinical outcome at Days 10 and 31 was identical in both treatment groups. Otoscopic findings improved more rapidly in the E/S group than in the cefaclor group at 10 and 31 days (P less than or equal to 0.04). In cases where pre-treatment middle ear fluid was negative on routine bacterial culture, complete cure at 10 days was observed in 75% of patients treated with E/S but only in 14% of those treated with cefaclor (P = 0.02). Side effects were infrequent and comparable between the test drugs. E/S is at least as effective as cefaclor in the management of acute otitis media and may be superior, particularly for cases not yielding bacteria on routine culture.