Efficacy of amoxicillin-clavulanate

Efficacy data on the use of amoxicillin-clavulanate in neonates are limited to case series in infants with urinary tract infection (UTI) and infants with ‘bacterial colonisation’ treated with antibiotics. [5,10] In a retrospective case, series of infants with median age 19 days with UTI, 49 were treated with ampicillin and gentamicin and 105 with amoxicillin-clavulanate and gentamicin. Switch to oral amoxicillin - clavulanate was used in 75%. No treatment failure or relapse was detected, whilst 11 (8.7%) of 126 patients had renal scarring at 6 months. [10]

A systematic review [11] of antibiotics for WHO defined non -severe community-acquired pneumonia in children included 29 trials with 14,188 children. None of the trials included infants <33 months of age. There was no difference in response or cure rates in comparing amoxicillin-clavulanic acid and azithromycin, cefpodoxime, penicillin and gentamycin, levofloxacin, and oxacillin and ceftriaxone. Amoxicillin -clavulanic acid was associated with an increased response rate compared to amoxicillin. Compared to azithromycin, amoxicillin-clavulanic acid was associated with an increase in side effects. In summary: Two trials with 276 infants >6 months age compared azithromycin versus amoxicillin-clavulanic acid 40 mg/kg/day for 10 days with meta-analysis finding no difference in failure rate [OR 1.21, 95% CI 0.42, 3.53] but more side effects with amoxicillin-clavulanic acid [OR 0.15, 95% CI 0.04,0.61]. One trial in 100 infants ≥2 years age compared amoxicillin-clavulanic acid 250 mg + 62.5 mg or

500 + 125 mg tds) versus amoxicillin reported reduced poor or no response [OR 0.08, 95% CI 0.01,0.67], increased cure rate OR 95% CI 10.44 [2.85, 38.21] and no difference in complications [OR 5.21, 95% CI 0.24, 111.24]. One trial with 278 infants aged ≥3 months compared cefpodoxime versus amoxicillin-clavulanic acid 6 to 13 mg/kg/day for 10 days and reported no difference in cure rate at end of treatment [OR 0.69, 95% CI 0.18, 2.60]. One trial with 71 infants aged 2 to 59 months compared penicillin and gentamycin versus amoxicillin-clavulanic acid 30 mg/kg IV q12 hourly for at least 3 days changed to oral when able to feed and reported no difference in failure rate [OR 0.86, 95% CI 0.05,14.39]. One trial with 539 infants ≥6 months age compared levofloxacin versus amoxicillin-clavulanic acid 22.5 mg/kg/dose 12 hourly for 10 days and reported no difference in cure rate [OR 1.05, 95% CI 0.46, 2.42]. One trial with 104 infants ≥2 months age compared oxacillin and ceftriaxone versus amoxicillin-clavulanic acid 100 mg/kg/day every 8 hours for 10 days and reported no difference in failure rate OR 95% CI 0.98 [0.33, 2.92] but decreased time for improvement in tachypnoea [MD -1.0, 95% CI -0.11, -1.89] and decreased length of stay [MD -3.40, 95% CI -5.46, -1.34].