Twenty-one single-centre RCTs were included. None of the studies were blinded: 14 evaluated children with acute otitis media (n=594) and 7 examined adults with bacterial sinusitis (n=304).
Brodimoprim was compared with amoxicillin (4 studies), ampicillin (4 studies), erythromycin (4 studies), cefradine (1 study) and cefalexin (1 study). With regard to the global clinical efficacy rating, the pooled data showed brodimoprim to be statistically significantly superior to erythromycin (OR 1.99, 95% CI: 1.02, 3.90, P=0.044), ampicillin (OR 4.20, 95% CI: 2.26, 7.80, P<0.0001) and cefalexin (OR 12.38, 95% CI: 2.86, 53.61, P=0.0008). No statistically significant difference was demonstrated between brodimoprim and either amoxicillin (shown to be equivalent) or cefradine.
Overall, brodimoprim was significantly superior to the comparator agents when global efficacy ratings were pooled and compared (OR 2.55, 95% CI: 1.82, 3.56, P<0.0001). No inter-group difference in the tolerability profile of brodimoprim versus that of its comparator agents was demonstrated (OR 0.81, 95% CI: 0.50, 1.30, P<0.0001).
Brodimoprim was compared with amoxicillin (2 studies), doxycycline (3 studies), cefalexin (1 study) and roxithromycin (1 study). A statistically significant difference in global clinical efficacy ratings was demonstrated in favour of brodimoprim when compared with amoxicillin (OR 3.20, 95% CI: 1.20, 8.55, P=0.0202). No statistically significant differences were demonstrated for any other comparator agent, although equivalence of brodimoprim with roxithromycin was proven.
No overt differences were demonstrated in the tolerability data from either individual or pooled investigations.