An evaluation of once daily cefdinir 25 mg/kg oral suspension in children with acute otitis media at risk of persistent or recurrent otitis media
Abstract number: 902_p1306
This phase 2/3, open-label, noncomparative, multi-centre study, assessed the efficacy of once daily CEF in the treatment of children with AOM at risk of PROM.
Children aged 6 months to 4 years with signs/symptoms of AOM at risk of PROM (characterised by >=2 of the following: antibiotics in previous 3 months, age <=2 years, day-care attendance or siblings/household contacts age <=8 years), diagnosed by pneumatic otoscopy and tympanocentesis, received once daily CEF for 10 days. Children were evaluated pretreatment (Day 1), on therapy (Days 46), end of therapy (Days 1214) and follow-up (Days 2528). Repeat tympanocentesis on Days 46 was used to assess bacteriologic response.
A total of 447 children were enrolled in the US, Israel and Latin America. Fifty-seven percent were male, 64% were <=2 years of age. For the 227 children clinically and bacteriologically evaluable, 58% were male and 74% were <=2 years of age; 13% had received pneumococcal conjugated vaccine. Forty-two percent of these children had >=3 AOM infections within the past 12 months (including present infection) and 56% had received treatment for AOM within previous 3 months. Fifteen percent had multiple pathogens isolated pretreatment. Forty-seven percent of S. pneumoniae isolates were penicillin non-susceptible (PNSP). Bacteriologic eradication on Days 4-6 was achieved in 159/226 (70%) children and 188/262 (72%) of all pathogens were eradicated. Bacteriologic response in children with a single pathogen was 148/193 (77%). Eradication of penicillin susceptible, intermediate and resistant S. pneumoniae was 84% (46/55), 65% (17/26) and 39% (9/23), respectively; eradication of H. influenzae was 84/123 (68%). Overall clinical response for clinically and bacteriologically evaluable children on Days 1214 was 82% and for S. pneumoniae and H. influenzae it was 75 and 82%, respectively. Clinical response on Days 2528 was 142/167 (85%). Clinical response for children with pretreatment negative and positive cultures was 97 and 82%, respectively. CEF was discontinued due to an adverse event in only 3% of children. The most common adverse events were diarrhoea (13%) and vomiting (7%), most of mild severity.
This study specifically evaluated children with AOM at risk for PROM. In this high-risk population, CEF demonstrated good activity against penicillin susceptible S. pneumoniae, but decreased activity against PNSP, and a moderate effect against other pathogens. Further studies are needed to evaluate modified dosing or formulations of CEF in this high-risk population."
|Session name:||XXIst ISTH Congress|
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