Efficacy and Safety of Modified Release Cefpodoxime Formulation in the Treatment of Acute Sinusitis.
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|ClinicalTrials.gov Identifier: NCT03729258|
Recruitment Status : Active, not recruiting
First Posted : November 2, 2018
Last Update Posted : May 20, 2019
|Condition or disease||Intervention/treatment||Phase|
|Sinusitis Sinusitis, Acute Rhinosinusitis Rhinosinusitis Acute Sinus Infection||Drug: Infex 400 MR Drug: Infex 200 IR||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Comparison of the Efficacy and Safety of Immediate (b.i.d) and Modified (q.d.) Release Cefpodoxime Formulations in the Treatment of Acute Sinusitis: a Double-blind, Randomized, Phase III, Non-inferiority Study.|
|Actual Study Start Date :||May 15, 2019|
|Estimated Primary Completion Date :||October 1, 2019|
|Estimated Study Completion Date :||December 1, 2019|
|Experimental: Cefpodoxime 200 (b.i.d)||
Drug: Infex 200 IR
Infex (cefpodoxime) 200mg twice a day (BID) for 10 days
|Active Comparator: Cefpodoxime 400 (q.d)||
Drug: Infex 400 MR
Infex (cefpodoxime) 400mg once a day (QD) for 10 days
- Effect of formulations on acute sinusitis symptoms [ Time Frame: 10 days ]
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.
- Effect of formulations on quality of life scale [ Time Frame: 10 days ]Quality of Life: Increase or decrease in quality of life. The outcome will be assessed by Short Form Health Survey (SF-12).
- Rate of microbiological response at the end of treatment [ Time Frame: 10 days ]
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,
- Evaluation of the safety of investigational products [ Time Frame: 10 days ]Number of Adverse Events That Are Related to Treatments and Participants with Abnormal Laboratory Values (hemogram, sedimentation, CRP)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03729258
|Bakırköy Dr. Sadi Konuk Training and Research Hospital|