Amoxicillin/Clavulanate Shows Significant Bacteriologic & Clinical Efficacy in Children with AOM

521 infants and children between 3 and 48 months of age with AOM

Open label multicenter study

Patients were treated with amoxicillin/clavulanate 90/6.4 mg/kg/day in two divided doses for 10 days

Bacteriologic efficacy evaluated by repeat tympanocentesis on Days 4 to 6 of therapy was successful if the initial pathogen could not be recovered from middle ear fluid culture or if no middle ear fluid could be aspirated

Clinical response on Days 12 to 15 was considered successful if the outcome was clinical cure or improvement. At the visit on Days 25 to 28, clinical response was defined as result of persistent clinical cure, or as failure

High dose amoxicillin/clavulanate caused bacteriologic eradication in 96% of bacteriologically evaluable children: 99% infected with S. pneumoniae, 92% infected with H. influenzae and 91% infected with both (Figure 1)

It eradicated S. pneumoniae from 98% of children solely with S. pneumoniae or along with H. influenzae infections

Bacteriologic eradication rates with amoxicillin/clavulanate were significantly higher if the isolates were penicillin-susceptible or -intermediate than if they were penicillin-resistant (100% vs. 91% isolates; P=0.02)

Penicillin-resistant isolates were common in younger (mean age, 12.8 vs. 19.1 months) and those children who had received a course of antibiotics within 3 months (80% vs. 39%) as compared to those who had penicillin-susceptible or -intermediate isolates

Amoxicillin/clavulanate eradicated H. influenzae from 94% of children solely with H. influenzae or along with S. pneumoniae infection

Clinical success occurred with amoxicillin/clavulanate in 89% children with bacteriologically documented AOM at the end-of-treatment visit on Days 12 to 15. Clinical success occurred in 71% children at follow-up.

Children with <2 risk factors were more likely to have clinical success on Days 12 to 15 (97% vs. 80%; P<0.001] and Days 25 to 28 (85% vs. 59%; P<0.001] than were those with >3 risk factors.

Mild to moderate adverse experiences of probable or suspected relationship to treatment occurred in 14% children with amoxicillin/clavulanate.