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Comparative efficacy and safety evaluation of cefaclor vs amoxycillin + clavulanate in children with Acute Otitis Media (AOM).
Indian J Pediatr. 2005 Mar; 72(3):233-8.IJ

Abstract

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 include Streptococcus pneumoniae, Hemophilus influenzae and Moxarella catarrhalis, and therefore antibacterial management should target against these isolates. Cefaclor, 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 organisms in 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 in most 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 twice-daily dosing, and proven tolerability suggest that it is a good alternative to agents traditionally used in acute otitis media.

Authors+Show Affiliations

Pediatric Department, B.Y. Nair Hospital, Mumbai, India. ashok.moharana@ranbaxy.comNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Comparative Study
Journal Article
Multicenter Study

Language

eng

PubMed ID

15812119

Citation

Aggarwal, Mukesh, et al. "Comparative Efficacy and Safety Evaluation of Cefaclor Vs Amoxycillin + Clavulanate in Children With Acute Otitis Media (AOM)." Indian Journal of Pediatrics, vol. 72, no. 3, 2005, pp. 233-8.
Aggarwal M, Sinha R, Murali MV, et al. Comparative efficacy and safety evaluation of cefaclor vs amoxycillin + clavulanate in children with Acute Otitis Media (AOM). Indian J Pediatr. 2005;72(3):233-8.
Aggarwal, M., Sinha, R., Murali, M. V., Trihan, P., & Singhal, P. K. (2005). Comparative efficacy and safety evaluation of cefaclor vs amoxycillin + clavulanate in children with Acute Otitis Media (AOM). Indian Journal of Pediatrics, 72(3), 233-8.
Aggarwal M, et al. Comparative Efficacy and Safety Evaluation of Cefaclor Vs Amoxycillin + Clavulanate in Children With Acute Otitis Media (AOM). Indian J Pediatr. 2005;72(3):233-8. PubMed PMID: 15812119.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Comparative efficacy and safety evaluation of cefaclor vs amoxycillin + clavulanate in children with Acute Otitis Media (AOM). AU - Aggarwal,Mukesh, AU - Sinha,Ramanuj, AU - Murali,M Vasudeva, AU - Trihan,Prita, AU - Singhal,P K, PY - 2005/4/7/pubmed PY - 2006/4/19/medline PY - 2005/4/7/entrez SP - 233 EP - 8 JF - Indian journal of pediatrics JO - Indian J Pediatr VL - 72 IS - 3 N2 - 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 include Streptococcus pneumoniae, Hemophilus influenzae and Moxarella catarrhalis, and therefore antibacterial management should target against these isolates. Cefaclor, 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 organisms in 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 in most 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 twice-daily dosing, and proven tolerability suggest that it is a good alternative to agents traditionally used in acute otitis media. SN - 0973-7693 UR - https://www.unboundmedicine.com/medline/citation/15812119/Comparative_efficacy_and_safety_evaluation_of_cefaclor_vs_amoxycillin_+_clavulanate_in_children_with_Acute_Otitis_Media__AOM__ L2 - https://medlineplus.gov/earinfections.html DB - PRIME DP - Unbound Medicine ER -