12823
document
Comparison of the efficacy and safety of faropenem daloxate and cefuroxime axetil for the treatment of acute bacterial maxillary sinusitis in adults . In this multicentre , multinational , comparative , double-blind clinical trial , outpatients with both clinical signs and symptoms and radiographic evidence of acute sinusitis were randomly assigned to receive for 7 days either a twice-daily oral regimen of faropenem daloxate ( 300 mg ) or a twice daily oral regimen of cefuroxime axetil ( 250 mg ) . Among 452 patients considered valid for clinical efficacy , faropenem daloxate treatment was found to be statistically equivalent to cefuroxime axetil ( 89.0 % vs. 88.4 % -95 % CI=-5.2 % ; +6.4 % ) at the 7-16 days post-therapy assessment . At 28-35 days post-therapy , the continued clinical cure rate in the faropenem daloxate group was 92.6 % and that for the cefuroxime axetil group was 94.9 % ( 95 % CI : -6.8 % ; +1.2 % ) . A total of 148 organisms was obtained in 136 microbiologically valid patients ( 30.1 % ) . The predominant causative organisms were Streptococcus pneumoniae ( 47.1 % ) , Haemophilus influenzae ( 30.1 % ) , Staphylococcus aureus ( 14.7 % ) and Moraxella catarrhalis ( 8.8 % ) . The bacteriological success rate at the 7-16 days post-therapy evaluation was similar in both treatment groups : 91.5 % and 90.8 % in the faropenem daloxate and cefuroxime axetil groups , respectively ( 95 % CI=-9.2 % ; +9.5 % ) . Eradication or presumed eradication was detected for 97.3 % and 96.3 % of S. pneumoniae , 85.0 % and 90.5 % of H. influenzae , 88.9 % and 90.9 % of S. aureus and 100.0 % and 83.3 % of M. catarrhalis in faropenem daloxate and cefuroxime axetil recipients , respectively . At least one drug-related event was reported by 9.5 % of the faropenem daloxate-treated patients and by 10.3 % of those who received cefuroxime axetil . The most frequently reported drug-related events were diarrhoea ( 2.2 % versus 2.9 % ) , nausea/vomiting ( 1.5 % vs. 0.7 % ) , abdominal pain ( 0.7 % vs 1.5 % ) and skin reactions ( 1.5 % vs. 1.1 % ) . Overall , faropenem daloxate was at least as effective clinically and bacteriologically as cefuroxime axetil and was well tolerated .
12824
Intervention_Pharmacological
faropenem daloxate and cefuroxime axetil
12825
Intervention_Pharmacological
faropenem daloxate ( 300 mg )
12826
Intervention_Pharmacological
cefuroxime axetil
12827
Intervention_Pharmacological
faropenem daloxate treatment
12828
Intervention_Pharmacological
cefuroxime axetil
12829
Intervention_Pharmacological
faropenem daloxate group
12830
Intervention_Pharmacological
cefuroxime axetil
12831
Intervention_Pharmacological
faropenem daloxate
12832
Intervention_Pharmacological
cefuroxime axetil
12833
Intervention_Pharmacological
faropenem daloxate and cefuroxime axetil
12834
Intervention_Pharmacological
faropenem daloxate-treated
12835
Intervention_Pharmacological
cefuroxime axetil
12836
Intervention_Pharmacological
faropenem daloxate
12837
Intervention_Pharmacological
cefuroxime axetil
12838
Outcome_Other
efficacy and safety
12839
Outcome_Physical
acute bacterial maxillary sinusitis
12840
Outcome_Other
clinical cure rate
12841
Outcome_Other
bacteriological success rate
12842
Outcome_Other
Eradication or presumed eradication
12843
Outcome_Adverse-effects
drug-related event
12844
Outcome_Adverse-effects
diarrhoea
12845
Outcome_Adverse-effects
nausea/vomiting
12846
Outcome_Adverse-effects
abdominal pain
12847
Outcome_Adverse-effects
skin reactions
12848
Outcome_Other
clinically and bacteriologically
12849
Outcome_Other
tolerated
12850
Participant_Condition
acute bacterial maxillary sinusitis
12851
Participant_Age
adults .
12852
Participant_Condition
acute sinusitis
12853
Participant_Sample-size
452