Efficacy and safety of cefdinir in the treatment of maxillary sinusitis

Abstract

Cefdinir is a new, extended-spectrum, orally active, third-generation cephalosporin that is resistant to bacterial beta-lactamase production. To evaluate efficacy and safety of the antibiotic in maxillary sinusitis, its use was compared with amoxicillin/clavulanate (amox/clav), which is a well-accepted beta-lactamase-resistant antibiotic. In this investigator-blinded multicenter phase III clinical study, 569 patients were randomly assigned to one of three treatment regimens: one daily dose of cefdinir 600 mg (OD), cefdinir 300 mg every 12 h (BD), and amox/clav 500/125 mg every 8 h. All antibiotics were administered orally for 10 days. Maxillary sinusitis was documented by typical clinical signs and symptoms and was confirmed by X-ray imaging. Before treatment, the genus and species of any pathogens were determined from sinus aspirates. Cultures were tested for beta-lactmase production and in vitro resistance to cefdinir and amox/clav. The effectiveness of antibiotic treatment was evaluated 7-14 days after therapy and whether or not recurrent clinical symptoms or persistent infection was determined 21-35 days post-therapy. The appearance of any adverse events was classified as associated or not associated with the medication of the study. Present findings showed that the in vitro susceptibility of pathogens to cefdinir and amox/clav was similar. Cefdinir OD or BD was therapeutically as effective as or better than amox/clav, although cefdinir BD was not as useful as amox/clav clinically. Cefdinir OD and BD and amox/clav were well tolerated. The statistical incidence of adverse events was the same among the three treatment groups, although cefdinir OD treatment had significantly fewer treatment discontinuations due to adverse events than BD and amox/clav.

The efficacy of cefdinir in acute bacterial rhinosinusitis

“…[52]. These data underscore the potential clinical benefit of selecting an antibacterial with a targeted spectrum of activity, rather than one that is unnecessarily broad spectrum [47,52].…”

“…Three randomised clinical trials have shown cefdinir to have efficacy similar to that of other recommended regimens in the treatment of ABRS [3,4,47].…”

“…Two randomised, investigator-blind, multi-centre trials have compared cefdinir with amoxicillin plus the β-lactamase inhibitor, clavulanate, in patients with ABRS [3,47]. One study was performed in the US and one in Europe.…”

Guidelines on the treatment of ABRS in adults

“…Extended‐spectrum cephalosporins have been shown to be effective, both in vitro and in clinical studies, against the organisms most commonly isolated in ABRS ( Streptococcus pneumoniae , Haemophilus influenzae and Moraxella catarrhalis ) (7,8). One example, cefdinir, has been shown in randomised trials to have clinical cure rates at the test‐of‐cure visit similar to those of amoxicillin/clavulanic acid and levofloxacin in patients with ABRS (8–10) (Table 1). In the study by Henry et al.…”

Therapeutic experience with cefdinir in the treatment of uSSSIs

“…Treatment discontinuations caused by gastrointestinal disturbances (e.g. diarrhoea) with cefdinir also appear low and are either comparable or lower than with other antimicrobial agents such as cephalexin (6,7) or amoxicillin/clavulanate (9,10).…”