Efficacy of cefditoren pivoxil and amoxicillin/clavulanate in the treatment of pediatric patients with acute bacterial rhinosinusitis in Thailand: a randomized, investigator-blinded, controlled trial.

BACKGROUND: The recommended treatment for acute bacterial rhinosinusitis in adults and children is 10 to 14 days of high doses of oral cephalosporins or amoxicillin/clavulanate.
OBJECTIVE: This study compared the clinical efficacy and tolerability of cefditoren pivoxil and amoxicillin/clavulanate in children with uncomplicated acute bacterial rhinosinusitis.
METHODS: This was a randomized, investigator-blinded, controlled study in pediatric patients (age 1-15 years) with clinical and radiographic signs and symptoms of acute rhinosinusitis. Patients were allocated to receive either cefditoren (8-12 mg/kg daily) or amoxicillin/clavulanate (80-90 mg/kg amoxicillin daily) for 14 days. Changes in sinus symptoms were assessed daily by patients or their parents using a quantitative symptom score (the S5 score). Rates of improvement, the primary efficacy measure, were also evaluated by the study investigators 7 and 14 days after the initial visit. Secondary outcome measures included time to improvement, adverse effects, and rates of relapse (assessed at days 21 and 28) and recurrence (assessed at day 60) of sinus symptoms. Relapse was defined as a subjective rating of lack of improvement at day 21 or 28 in a patient rated as improved on day 14, and recurrence was defined as sinus symptoms lasting for >or=10 days during the second month of follow-up in a patient rated as improved on day 28. Time to improvement was defined as the number of days between the initial visit and the time at which caregivers noted an improvement in patients' symptoms. Adverse events were monitored by parents/caregivers using a self-administered questionnaire and were also elicited by telephone contact.
RESULTS: The study enrolled 142 pediatric patients: 70 in the cefditoren group (42 males, 28 females; median age, 7.15 years) and 72 in the amoxicillin/clavulanate group (37 males, 35 females; median age, 6.60 years). Four patients in the cefditoren group were excluded from the study analyses (2 who were noncompliant [used <80% of the assigned medication] and 2 who developed infection at other sites). There were no significant differences in baseline medical history or signs and symptoms between the 2 groups. Rates of improvement at day 14 in the cefditoren and amoxicillin/clavulanate groups were 78.8% (52/66) and 84.7% (61/72), respectively (P = NS). There was no significant difference in the change in S5 scores between groups at day 14. The median time to improvement was 3.0 days in both groups. There were no significant differences between groups in rates of relapse (9.1% and 11.1%) or recurrence (3.0% and 5.6%) of sinus symptoms. The most common adverse event in both groups was diarrhea, occurring in 4.5% of the cefditoren group and 18.1 % of the amoxicillin/clavulanate group (P = 0.02).
CONCLUSION: In these children with acute bacterial rhinosinusitis, there were no significant differences between cefditoren and amoxicillin/clavulanate, the currently recommended treatment, in terms of rates of response, relapse, or recurrence.

RCT Entities:   Population Interventions Outcomes