Comparison of cefuroxime axetil and amoxicillin/clavulanate in the treatment of acute bacterial sinusitis.

This double-masked, multicenter, randomized clinical trial compared the efficacy and tolerability of cefuroxime axetil and amoxicillin/clavulanate in the treatment of acute bacterial maxillary sinusitis. A total of 263 patients with acute bacterial maxillary sinusitis were randomly assigned to receive 10 days of treatment with either cefuroxime axetil 250 mg twice daily (n = 132) or amoxicillin/clavulanate 500/125 mg 3 times daily (n = 131). Patients' responses to treatment were assessed once during treatment (6 to 8 days after the start of treatment), at the end of treatment (1 to 3 days posttreatment), and at follow-up (26 to 30 days after cessation of treatment). Clinical success, defined as cure or improvement, was equivalent in the cefuroxime axetil and amoxicillin/ clavulanate groups at the end-of-treatment and follow-up assessments. Patients in both groups showed improvements in symptoms of acute sinusitis at the during-treatment visit. Treatment with amoxicillin/clavulanate was associated with a significantly higher incidence of drug-related adverse events than treatment with cefuroxime axetil (29% vs 17%), primarily reflecting a higher incidence of gastrointestinal adverse events (23% vs 11%), particularly diarrhea. Two patients in the cefuroxime axetil group and 8 patients in the amoxicillin/clavulanate group withdrew from the study due to adverse events (P = 0.06). These results indicate that cefuroxime axetil 250 mg twice daily is as effective as amoxicillin/clavulanate 500 mg 3 times daily in the treatment of acute sinusitis and produces fewer gastrointestinal adverse events. cefuroxime axetil, amoxicillin/clavulanate, acute sinusitis.

Comparative effectiveness and safety of cefdinir and amoxicillin-clavulanate in treatment of acute community-acquired bacterial sinusitis. Cefdinir Sinusitis Study Group.

Cefdinir is an extended-spectrum oral cephalosporin that is active against pathogens commonly seen in acute community-acquired bacterial sinusitis (ACABS), including Streptococcus pneumoniae, Haemophilus influenzae, and Moraxella catarrhalis. Two randomized, investigator-blind, multicenter trials (one in the United States and one in Europe) compared two dosage regimens of cefdinir (600 mg once a day for 10 days and 300 mg twice a day for 10 days) to amoxicillin-clavulanate (A-C) (500 mg three times a day for 10 days) for adult and adolescent patients with ACABS. Twelve hundred twenty-nine patients entered the U.S. study, 698 with antral puncture; 569 patients entered the European study, all with antral puncture. Clinical response (cure or improvement) was determined 7 to 14 days and 3 to 5 weeks posttherapy. Microbiologic eradication rates were determined 10 to 30 days posttherapy in a subset of patients who underwent pre- and posttherapy sinus aspirate culture. Rates of adverse events and treatment discontinuations due to adverse events were examined. Cefdinir, given once or twice daily, was as effective clinically (approximately 90% cure rate) as amoxicillin-clavulanate given three times daily in the treatment of ACABS. Microbiologic eradication rates were also similar in the three groups. The major side effect was mild diarrhea, occurring in approximately 20% of each group. Cefdinir caused fewer adverse events requiring treatment discontinuation.

The microbial etiology and antimicrobial therapy of adults with acute community-acquired sinusitis: a fifteen-year experience at the University of Virginia and review of other selected studies.

Pretreatment sinus puncture was performed on 339 patients with acute community-acquired sinusitis (ACAS) between 1975 and 1990. Bacterial species recovered in titers of greater than or equal to 10(4) colony-forming units per milliliter (CFU/ml) from 383 sinus aspirates included Streptococcus pneumoniae, 92 (41%); Haemophilus influenzae, 79 (35%); anaerobes, 17 (7%); streptococcal species, 16 (7%); Moraxella catarrhalis, 8 (4%); Staphylococcus aureus, 7 (33%); and other, 8 (4%). Viruses (rhinovirus, parainfluenza virus, and influenza virus) and fungi (Aspergillus, zygomycoses, Phaeohyphomycis, Pseudallescheria, and Hyalohyphomycis) have also been reported to cause ACAS. Posttreatment sinus puncture was performed on 220 of the 339 patients in six studies to evaluate efficacy of selected antimicrobial agents in producing bacteriologic cure. Ampicillin, 500 mg four times daily; amoxicillin, 500 mg three times daily; trimethoprim-sulfamethoxazole, twice a day; cefaclor, 500 mg four times daily; bacampicillin, 800 mg twice a day; cyclacillin, 500 mg three times a day; cefuroxime axetil, 250 mg twice daily; amoxicillin-clavulanate, 500/125 three times daily; and loracarbef 400 mg twice daily, given in 10-day courses, produced bacteriologic cure in more than 90% of patients. Early studies were done before beta-lactamase-producing strains of H. influenzae were a frequent cause of ACAS in Charlottesville. Management of therapeutic failures is a difficult problem for which diagnostic and therapeutic sinus puncture and lavage, prolonged antimicrobial therapy, steroid therapy, and evaluation of allergy, immunodeficiency, and surgically correctable lesions of the osteomeatal complex are recommended.

Comparative evaluation of cefuroxime axetil and cefaclor for treatment of acute bacterial maxillary sinusitis.

Cefuroxime axetil, a new beta-lactamase-stable cephalosporin, was compared with cefaclor for the treatment of acute bacterial maxillary sinusitis in 106 adult patients. Direct sinus aspirations for quantitative bacterial culture were done for all patients before treatment; aspiration was repeated for most patients after treatment. Pretreatment sinus aspirates were positive for 63 of 134 sampled sinuses. Of specimens yielding at least 10(4) CFU/mL, Haemophilus influenzae (38%) and Streptococcus pneumoniae (37%) were the most common pathogens. Ten (42%) of 24 strains of H influenzae, 2 (40%) of 5 Haemophilus parainfluenzae, and all 3 isolates (60%) of Branhamella catarrhalis produced beta-lactamase. Cefuroxime axetil, 250 mg twice a day, was compared with cefaclor, 500 mg three times a day. Among culture-positive sinuses, bacteriologic cure was achieved in 36 (95%) of 38 sinuses and 15 (71%) of 21 sinuses treated with cefuroxime axetil and cefaclor, respectively. The overall frequencies of adverse events were similar between drugs, although cefuroxime axetil was associated with more frequent diarrhea. Cefuroxime axetil was an effective therapy for the treatment of acute bacterial maxillary sinusitis in adults.

Comparison of cyclacillin and amoxicillin for therapy for acute maxillary sinusitis.

Cyclacillin, a new aminosalicylic semisynthetic penicillin, was compared with amoxicillin for the therapy of acute bacterial maxillary sinusitis in 80 patients (ages, 12 to 70 years) in a prospective, double-blind, randomized clinical trial. Direct sinus aspirations for quantitative culture were done for all patients before and after 10 days of therapy. Both drugs were administered at a dosage of 500 mg orally three times daily. Among culture-positive patients, clinical cure was achieved in 23 of 26 patients and 25 of 27 patients treated with cyclacillin and amoxicillin, respectively, for an overall cure rate of 91%. Bacteriologic failure occurred in 9% (4 of 44 patients); 3 of the 4 failures were in the cyclacillin group. There was no correlation between clinical or bacteriologic cure and the results of sinus transillumination (clear, dark) at follow-up. Initial direct sinus aspirates were positive in 57 of 80 cases (70%): 25 (44%) of these were the result of Streptococcus pneumoniae and 23 (40%) were the result of Haemophilus influenzae. All of these isolates were susceptible (MIC, less than or equal to 0.5 microgram/ml) to both study drugs; no ampicillin-resistant H. influenzae was recovered. On day 10 of therapy, mean concentrations of both drugs in serum were 2.5 to 2.7 micrograms/ml, but no antibiotic was detectable in 20 of 21 simultaneous sinus aspirates. Adverse effects (rash, diarrhea) were infrequent and similar in both groups. Cyclacillin appears equivalent to amoxicillin in the therapy of acute maxillary sinusitis.

Etiology and antimicrobial treatment of acute sinusitis.

Acute maxillary sinusitis is a disease of varied etiology. Over half of the cases are caused by Streptococcus pneumoniae and Hemophilus influenzae. Anaerobic bacteria account for another 10% of cases and these are usually of dental origin. The rest of the cases are caused by several other bacteria, each of which cause a small proportion. Rhinoviruses, influenza, and parainfluenza viruses also invade the sinuses and probably lead to secondary bacterial infection. Diagnosis of acute sinusitis on clinical grounds is difficult. Sinus transillumination and x-ray are the most valuable routine tests available. Ampicillin, amoxicillin, trimethoprim-sulfamethoxazole, and cefaclor have been shown to be effective treatment for most cases of acute sinusitis. Infection persists when there is inadequate or inappropriate treatment. The patient may become relatively asymptomatic in the face of persistent active infection. Follow-up clinical and x-ray examinations are indicated, when possible, to detect treatment failures. Although not a routine diagnostic procedure, sinus puncture and aspiration may be of value in the seriously ill patient or one who has not responded to treatment.

Etiology and antimicrobial therapy of acute maxillary sinusitis.

Eighty-one adults with symptoms of acute sinusitis were studied by direct needle puncture and aspiration of the maxillary sinus (105 sinuses). Fifty-nine bacterial strains were isolated in titers of greater than or equal to 10(4) colony-forming units/ml; Streptococcus pneumoniae and Haemophilus influenzae accounted for 64% of the isolates. Other bacteria recovered included anaerobes (12%), Neisseria species (8.5%). Streptococcus pyogenes (3%), alpha-hemolytic Streptococcus (3%), non-group A beta-hemolytic Streptococcus (3%), Staphylococcus aureus (2%), Pseudomonas aeruginosa (2%), and Escherichia coli (2%). Viruses were isolated from 11 sinuses; these isolates included rhinovirus (six), influenza A (H3N2) virus (three), and two types of parainfluenza virus (one each). The efficacy of therapy with orally administered ampicillin, amoxicillin, or trimethoprim-sulfamethoxazole was evaluated by a repeat sinus puncture and culture. Clinical and bacteriologic responses to all three regimens were good.