Comparative, multicenter studies of cefixime and amoxicillin in the treatment of respiratory tract infections.

A total of 560 patients were treated in two double-blind, randomized multicenter studies to compare the safety and efficacy of cefixime (400 mg administered once daily) and amoxicillin (250 or 500 mg administered three times daily) for the treatment of bacterial respiratory tract infections. Eighty percent of the 244 patients treated in the lower respiratory tract infections (LRTI) study had acute bronchitis. Streptococcus pneumoniae (13 percent), Haemophilus influenzae (28 percent), and Escherichia coli (10 percent) were the pathogens most frequently isolated from sputum in these patients. Among evaluable patients with positive bacterial culture results at baseline, a favorable clinical response (cured or improved) was obtained in 100 percent of the cefixime-treated patients (22 of 22) and in 96 percent of the amoxicillin-treated patients (23 of 24). Bacteriologic eradication rates were 100 percent and 83 percent for cefixime and amoxicillin, respectively. In the upper respiratory tract infections (URTI) study, 316 patients with pharyngitis (80 percent) or tonsillitis (14 percent) were treated. Group A, beta-hemolytic Streptococcus (69 percent) and H. influenzae (8 percent) were the pathogens most frequently isolated from the throat culture specimens of these patients. Favorable clinical results were obtained in 99 percent of the evaluable cefixime-treated group (n = 73) and in 98 percent of the amoxicillin-treated group (n = 66). The bacteriologic eradication rates were 93 percent and 100 percent, respectively. The adverse experiences reported during both studies were similar in nature and frequency to those reported for other beta-lactam antibiotics with the exception of a higher incidence of altered bowel movement (diarrhea and stool changes) with both drugs. These episodes usually resolved without remedial medication when the treatment was withdrawn. No significant adverse laboratory findings were observed. Results of these trials demonstrate that cefixime at a dosage of 400 mg once daily is an effective and safe oral antibiotic for the treatment of acute respiratory tract infections.

RCT Entities:   Population Interventions Outcomes