Cefcanel daloxate

A new oral prodrug cephalosporin, cefcanel daloxate, was compared with cefaclor, another oral cephalosporin, in the treatment of acute purulent maxillary sinusitis. Three hundred fifty-four patients with purulent sinus secretion were recruited and randomized at thirteen European ENT clinics for the double blind study. The patients were treated with either cefcanel 300 mg tablets twice daily or cefaclor 250 mg capsules three times daily for ten days. Apart from the sinus puncture and secretion aspiration, the existence of sinus pain and purulent nasal secretion were inclusion criteria. Between days 12 and 15, reaspiration of the sinus was performed and signs and symptoms noted. The latter were checked again at the final visit between days 25 and 30. Samples of blood and urine were obtained for safety evaluation at inclusion, during and after treatment. The bacteriological culture of the purulent sinus secretion in 58.4% of patients revealed Haemophilus influenzae (37.9%) as the most prevalent pathogen followed by Streptococcus pneumonia (19.7%), while Streptococcus pyogenes, Branhamella catarrhalis, and Staphylococcus aureus amounted each to 6-7% only. The overall clinical outcome was defined as cure/improvement in 83.3% of the patients in the cefcanel group and 89.3% in the cefaclor group, respectively. No statistically significant differences with regard to efficacy were found between the two treatment groups. Adverse events, mostly related to gastrointestinal reactions, were reported by 36 patients (15.7%) in the cefcanel group and by 16 (13.4%) in the cefaclor group. Both cefcanel 300 mg twice daily and cefaclor 250 mg three times daily were highly effective with only minimal adverse events in the treatment of acute purulent maxillary sinusitis.

Objective: To determine the efficacy, safety and tolerance of cefcanel daloxate and phenoxymethylpenicillin (PcV) in the treatment of acute pharyngotonsillitis caused by beta‐hemolytic streptococci group A (bhsga).Patients and Methods: Randomized, double‐blind, multicentre study with subjects randomized 1:1:1:1 to four parallel treatment groups: cefcanel daloxate 150 mg bid, 300 mg bid, 600 mg daily and PcV 300 mg tid. Patients were treated for 10 days with clinical, bacteriological and safety evaluation at inclusion, during therapy (day 5), early after completion of therapy (day 14) and two weeks later (day 28).Results: Of 340 subjects enrolled, 324 were valid for safety analysis and 249 for efficacy analysis. At the short term visit, clinical cure rates for cefcanel daloxate 300 mg bid and PcV groups were similar at approximately 70%. The cure rates for cefcanel daloxate 150 mg bid and 600 mg daily were significantly worse at 57.4 and 54.4%. Approximately 80% of all pretherapy throat swabs grew bhsga. All bhsga were susceptible or intermediately susceptible to PcV and cefcanel. The bacterial elimination rate for cefcanel daloxate was 82.8% and for PcV it was 89.8%. The elimination rate was significantly lower in the cefcanel daloxate 150 mg bid and 600 mg daily groups. The clinical cure rates and the bacteriological elimination rates increased by about 10% for cefcanel daloxate 300 mg bid and the PcV groups at the last valid visit and remained significantly better than the other two cefcanel daloxate doses. Adverse events were not significantly different among the four treatment groups.Conclusions: Cefcanel daloxate 300 mg bid was as effective and as well tolerated as PcV 300 mg tid in the treatment of acute pharyngotonsillitis. A lower dose or once‐daily dose regimen of cefcanel daloxate was not as effective clinically or bacteriologically.