Comparative efficacy and safety evaluation of cefaclor VS amoxycillin + calvulanate in children with Acute Otitis Media (AOM)

• Published in: Indian journal of pediatrics 2005-03, Vol.72 (3), p.233-238
• Main Authors: Aggarwal, Mukesh, Sinha, Ramanuj, Murali, M Vasudeva, Trihan, Prita, Singhal, P K
• Format: Article
• Language: English
• ISSN: 0019-5456; 0973-7693
• DOI: 10.1007/BF02859264

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