A Randomized, Open Label, Prospective, Comparative Study Evaluating the Efficacy and Safety of Fixed Dose Combination of Cefpodoxime 200 Mg + Clavulanic Acid 125 Mg Vs Cefpodoxime 200 Mg in Acute Bacterial Sinusitis.
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Date
2015-06
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Abstract
Background: Fixed dose combination of cefpodoximeclavulanic
acid and cefpodoxime both are commonly used
in the treatment acute bacterial sinusitis. However,
comparative clinical studies between the fixed dose
combination of cefpodoxime-clavulanic acid versus
cefpodoxime alone are not available. Objective: A postmarketing
study was conducted to evaluate the efficacy
and safety of fixed dose combination of cefpodoxime
proxetil plus potassium clavulonate versus cefpodoxime
proxetil in treatment of acute bacterial sinusitis. Material
and methods: A total of 202 patients were enrolled in an
open label, randomized, parallel group, two arms multicentric
study. Patients were treated either with fixed dose
combination of cefpodoxime 200 mg plus clavulanic acid
125 mg or cefpodoxime 200 mg; both given as one tablet
twice daily for ten days. The efficacy was evaluated at
baseline, day three, day five and day ten while the safety
was assessed at screening and day 10. Statistical analysis:
Intention to treat population was used to analyse the safety
results while efficacy was evaluated in per protocol
population. Chi square test was used to evaluate the efficacy
parameters on six point Likert scale, global evaluation of
efficacy and safety by investigators and patients. Results:
Cure rate was higher in study group (58.43%) compared
to control group (46.81%), however, the difference was
not significant. No significant difference was seen in
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Keywords
acute sinusitis, cefpodoxime, potassium clavulonate
Citation
Das Srirupa, Fegade Tushar. A Randomized, Open Label, Prospective, Comparative Study Evaluating the Efficacy and Safety of Fixed Dose Combination of Cefpodoxime 200 Mg + Clavulanic Acid 125 Mg Vs Cefpodoxime 200 Mg in Acute Bacterial Sinusitis. Indian Medical Gazette. 2015 Jun; 149(6): 225-231.