Acute
Otitis Media (AOM) is the most frequent
respiratory tract infection of infancy and childhood that is treated with
antimicrobial agents. The most common causative pathogens includeStreptococcus pneumoniae, Hemophilus influenzae andMoxarella catarrhalis, and therefore antibacterial management should target against these isolates. Cefactor, a congener of
cephalexin monohydrate, is a semisynthetic
cephalosporin antibiotic. It is an orally active
cephalosporin which has demonstrated activity against a wide range of organismsin vitro. Present study is designed as a multicentric prospective trial to study and compare the efficacy and safety of
cefaclor versus amoxicillin+clav in children with acute
otitis media. One hundred and sixty seven patients were evaluated for efficacy endpoints in the
cefaclor arm comprised of 104 males and 63 females with a mean age of 5.74±2.80 years and 185 patients in the amoxy-clav group comprised of 118 males and 67 females with a mean age of 4.93±2.92 years. Both
cefaclor and amoxy-clav caused a significant improvement in all the signs and symptoms after a 10-day treatment period. However, between-the-group comparisons showed that the reduction i nmost of the symptoms was significantly more in
cefaclor arm as compared to
amoxicillin-clav arm. The clinical success (clinical cure + improvement) at the end of
therapy was significantly more in
cefaclor arm: 98% with
cefaclor versus 85% with amoxicillin+clav, p<0.05 (Table 3). Failure cases were prescribed other
antibiotics according to the culture sensitivity reports, as rescue medication. Bacterial eradication rates were largely consistent with clinical responses. Bacteriological eradication was seen in 95% of patients in
cefaclor group and 78% of patients in amoxicillin+clav group. In conclusion,
cefaclor is a well tolerated and effective antibacterial option for acute
otitis media in children and it is superior to the combination of amoxicillin+clav in efficacy and tolerability in acute AOM. Moreover, its expanded spectrum of activity, ability to achieve adequate concentrations in tissues, suitability for twicedaily dosing, and proven tolerability suggest that it is a good alternative to agents traditionally used in acute
otitis media.