The aim of this study is to compare the efficacy and safety of cefpodoxime 200 mg immediate (b.i.d) and cefpodoxime 400 mg modified release (q.d) tablet formulations in the treatment of acute bacterial rhinosinusitis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
100
Infex (cefpodoxime) 400mg once a day (QD) for 10 days
Infex (cefpodoxime) 200mg twice a day (BID) for 10 days
Bakırköy Dr. Sadi Konuk Training and Research Hospital
Istanbul, Turkey (Türkiye)
RECRUITINGEffect of formulations on acute sinusitis symptoms
Change in acute sinusitis sign and symptoms at the end of treatment compared to baseline. The outcome will be assessed by Sino-nasal Outcome Tests SNOT-22 and SNOT-16. \* SNOT-16 is recommended symptom questionnarie for acute rhinonusitis but Turkish validation is not existed. Therefore SNOT-22 is also added as a symptom questionnarie since Turkish Validation is available.
Time frame: 10 days
Effect of formulations on quality of life scale
Quality of Life: Increase or decrease in quality of life. The outcome will be assessed by Short Form Health Survey (SF-12).
Time frame: 10 days
Rate of microbiological response at the end of treatment
Patients will be given sample from middle meatus. The outcome will be assessed according to microbiologic response: Eradication: The absence of pathogen(s) at the end of treatment. Persistance: The same concentration of the pathogen(s) in culture after the end of treatment. Superinfection: Detection of bacterial of fungal pathogens during or after treatment,
Time frame: 10 days
Evaluation of the safety of investigational products
Number of Adverse Events That Are Related to Treatments and Participants with Abnormal Laboratory Values (hemogram, sedimentation, CRP)
Time frame: 10 days
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