Sixteen RCTs (3,450 evaluable patients) and one open clinical study (67 patients) were included.
Ceftibuten was as effective as cefaclor in the management of acute bronchitis, bronchiectasis, acute exacerbation of chronic bronchitis, and pneumonia. In adults, ceftibuten was as effective as ciprofloxacin, clarithromycin, cefuroxime and amoxicillin-clavulanate for acute exacerbation of chronic bronchitis, and was comparable with amoxicillin-clavulanate for acute bacterial sinusitis. Ceftibuten was as effective as amoxicillin-clavulanate, cefaclor and cefprozil in the empiric treatment of acute otitis media, and was comparable with amoxicillin in the treatment of otitis media with effusion.
However, pooled data from three clinical trials indicated that the bacteriologic eradication rate for ceftibuten was 22% less than that of the control antibiotics (not specified) for patients with acute exacerbations of chronic bronchitis in whom M. catarrhalis was isolated from sputum at baseline, and 23% less for children with acute otitis media in whom S. pneumoniae was isolated at baseline.
Adverse reactions to ceftibuten were limited to the gastrointestinal tract and included abdominal pain, diarrhoea, dyspepsia and nausea.