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Treatment of sinus empyema in adults. A coordinated Nordic multicenter trial of cefixime vs. cefaclor
C Carenfelt1, I Melen, L Odkvist
1Department of Oto-Rhino-Laryngology, Karolinska Hospital, Stockholm, Sweden.
Abstract:
In sinus empyema, H. influenzae is the most prevalent pathogen in some subpopulations and in case of therapeutic failure. Cefixime, the first oral cephalosporin of the 3rd generation, is highly potent in vitro against H. influenzae. To study the efficacy and safety of cefixime in adults with acute sinusitis, a coordinated, double-blind multicenter trial was designed for purulent cases, as confirmed by antral aspiration. A total of 364 patients were enrolled in the study with 125 cases randomized to the reference group, assigned to treatment with cefaclor. Evaluation was based on clinical outcome and on antral reaspiration (86% of the cases). No significant differences between the treatment groups were found, as regards short-term or long-term clinical outcome. However, the clinical examination overestimated the therapeutic results. Only 4% of the patients were considered as failures, but the re-aspiration demonstrated remaining suppuration in 14% of all cases (p less than 0.001). Based on re-aspiration, the failure rate among patients with initial growth of pathogens was lower for cefixime (8%) than for cefaclor (20%) (p less than 0.05). Such a difference was not found among patients with growth of H. influenzae. No serious adverse reactions were recorded, but loose stools and diarrhoea were significantly more frequent in the cefixime treatment group. Five patients (2%) in the cefixime treatment group discontinued their treatment due to adverse events.
Insights
Cefixime showed comparable clinical outcomes to cefaclor for acute sinusitis but revealed higher efficacy based on re-aspiration, particularly in non-H. influenzae infections. Loose stools and diarrhea were more common with cefixime.
Area of Science:
- Infectious Diseases
- Pharmacology
- Otolaryngology
Background:
- Sinus empyema often involves *Haemophilus influenzae*, a pathogen susceptible to cefixime.
- Cefixime is a potent, third-generation oral cephalosporin effective against *H. influenzae*.
Purpose of the Study:
- To evaluate the efficacy and safety of cefixime versus cefaclor in adults with acute sinusitis.
- To compare treatment outcomes using clinical assessment and antral re-aspiration.
Main Methods:
- A coordinated, double-blind, multicenter trial enrolled 364 adult patients with purulent sinusitis.
- Patients received either cefixime or cefaclor, with outcomes assessed clinically and via antral re-aspiration.
- 86% of patients underwent re-aspiration to confirm treatment success.
Main Results:
- Clinical outcomes showed no significant difference between cefixime and cefaclor.
- Antral re-aspiration revealed a higher failure rate (14%) than clinical assessment (4%).
- Cefixime demonstrated a lower failure rate (8% vs. 20%) based on re-aspiration for non-*H. influenzae* infections (p<0.05).
- Adverse events included significantly more loose stools and diarrhea with cefixime; 2% discontinued treatment.
Conclusions:
- Clinical evaluation may overestimate sinusitis treatment success.
- Cefixime is effective for acute sinusitis, with improved outcomes over cefaclor when confirmed by re-aspiration, especially for non-*H. influenzae* pathogens.
- While generally safe, cefixime is associated with increased gastrointestinal side effects.