Comparison ofCefuroxime Axetil andAmoxicillin-Clav ulanate Suspensions inTreatment ofAcuteOtitis MediawithEffusion inChildren

suspension (AMX-CL)in thetreatment ofacute otitis mediawitheffusion. Patients received CAEat30mg/kgofbodyweight perday(n = 165)intwodivided doses orAMX-CLat40mg/kg/day (n= 98)inthree divided dosesfor10days. The primary pathogens among200isolates frompretreatment cultures ofmiddle earfluid wereidentified as follows: Haemophilus influenzae (39%o), overa third ofwhichwereP-lactamase positive; Streptococcus pneumoniae (34%); andMoraxeUla catarrhalis (16%). Pathogens wereeradicated orpresumed tobeeradicated from81%(95of118)and76%(50of66)ofbacteriologically evaluable patients intheCAEandAMX-CL groups, respectively. A satisfactory clinical response (cure orimprovement withorwithout resolution of effusion) occurred in113(77%) of146clinically evaluable patients intheCAEgroupandin66(74%)of89 evaluable patients intheAMX-CLgroup. Clinical failure orrecurrence (within 2 weeksfollowing the completion oftreatment) occurred in22and26%ofCAE-andAMX-CL-treated patients, respectively. Drug-related adverse events occurred in18%ofCAE-treated patients, whereas theyoccurred in39%o of AMX-CL-treated patients (P< 0.001); diarrhea orloose stools wasthemostcommonly reported adverse event (CAE, 12%;AMX-CL,31%;P < 0.001). Theseresults indicate thatCAEgiven twice daily isaseffective as AMX-CLgiven three times daily inthetreatment ofacute otitis mediawithelfusion inpediatric patients, but CAEwasassociated withsignificantly fewer drug-related adverse events. Acuteotitis mediaisanextremely commonandfrustrating medical problem, afact only toofamiliar topediatricians who attend youngsters withthis condition onnearly adaily basis andtothechildren's caretakers, whosenormal routine isso often disrupted asaresult. Prompt treatment ofacuteotitis mediaisdesirable inorder torelieve thechild's immediate discomfort. Inaddition, effective therapy should lessen the likelihood oflong-term sequelae, suchashearing lossor permanent middle eardamage (3, 8,12). Successful management ofacuteotitis mediadepends on manyfactors, including knowledge oftheetiologic organisms, primarily Streptococcus pneumoniae, Haemophilus influenzae, andMoraxella catarrhalis (2,4), andtheir particular susceptibilities toantimicrobial agents. Regional antimicrobial resistancepatterns mayalsoinfluence treatment, asmayhost factors, suchasrecenthistory oftreatment foracuteotitis media. Thechoice ofantibiotic therapy remains controversial, however, andissubject tochange asnewinformation both aboutthedisease andabout treatment modalities becomes available. We present datacomparing theefficacy andsafety ofthe suspension formulation ofcefuroxime axetil (CAE), theester prodrug ofcefuroxime, withthatofamoxicillin-clav ulanate