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Efficacy and Safety of Modified Release Cefpodoxime Formulation in the Treatment of Acute Sinusitis.

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ClinicalTrials.gov Identifier: NCT03729258
Recruitment Status : Recruiting
First Posted : November 2, 2018
Last Update Posted : July 12, 2019
Sponsor:
Information provided by (Responsible Party):
Neutec Ar-Ge San ve Tic A.Ş

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Sinusitis Sinusitis, Acute Rhinosinusitis Rhinosinusitis Acute Sinus Infection Drug: Infex 400 MR Drug: Infex 200 IR Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sinusitis

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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.


  2. 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).

  3. 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,



Secondary Outcome Measures :
  1. 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)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 18 years and older patients who have acute bacterial rhinosinusitis sign and symptoms (i, ii, iii) according to IDSA Clinical Practice Guideline for Acute Bacterial Rhinosinusitis in Children and Adults: i. Onset with persistent symptoms or signs* compatible with acute rhinosinusitis, lasting for ≥ 10 days without any evidence of clinical improvement, ii. Onset with severe symptoms or signs of high fever > 39 and purulent nasal discharge or facial pain lasting for at least 3-4 consecutive days at the beginning of illness, iii. Onset with worsening symptoms or signs characterized by the new onset of fever, headache, or increase in nasal discharge that lasted 5-6 days and were initially improving.

    (*Major symptoms: Purulent anterior nasal discharge, Purulent or discolored posterior nasal discharge, Nasal congestion or obstruction, Facial congestion or fullness, Facial pain or pressure, d Hyposmia or anosmia. *Minor symptoms: Headache, Ear pain, pressure, or fullness, Halitosis, Dental pain, Cough, Fatigue)

  2. Patients who are able to give culture sample from middle meatus (microorganisms to be teste: Streptococcus pneumoniae, Haemophilus influenzae [including beta-lactamase producing strains], Streptococcus pyogenes and Moraxella catarrhalis [including beta-lactamase producing strains]).
  3. Patients who are able to use oral drugs,
  4. If patient is a women of childbearing age; female patients who applies appropriate birth control,
  5. Patients who have ability to communicate with investigators,
  6. Patients who commits to adhere to the study protocol,
  7. Patients who sign informed consent form.

Exclusion Criteria:

  1. Patients who have hypersensitivity to beta-lactam antibiotics, penicillin and cefpodoxime,
  2. Patients who hypersensitivity to peanut and soy,
  3. Patients who have kidney or liver deficiency,
  4. Patients who have history of more than 2 bacterial sinusitis episode within last 12 months,
  5. Patients who have chronic sinusitis,
  6. Patients who have history of head and neck surgery and/or severe sinusitis complication (brain abscess or venous thrombosis),
  7. Patients who are hospitalized within 4 weeks prior to the start of study,
  8. Patients who have immunodeficiency (i.e; HIV, corticosteroid use, immunosuppressive use),
  9. Patients who used antibiotics within 30 days prior to the start of study,
  10. Patients who need to use of antibiotics other than investigational drugs for concomitant disease,
  11. Patients who used aluminium and magnesium containing anti-acids, probenecid and iron containing drugs within 2 weeks prior to the start of study,
  12. Pregnant and lactating female patients.

Information from the National Library of Medicine

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


Contacts
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Contact: Neutec RDC 00905051747902 iremkaraman@neutecrdc.com

Locations
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Turkey
Bakırköy Dr. Sadi Konuk Training and Research Hospital Recruiting
Istanbul, Turkey
Contact: İbrahim Sayın, Assoc Prof Dr         
Contact       dribrahimsayin@yahoo.com   
Sponsors and Collaborators
Neutec Ar-Ge San ve Tic A.Ş

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Responsible Party: Neutec Ar-Ge San ve Tic A.Ş
ClinicalTrials.gov Identifier: NCT03729258     History of Changes
Other Study ID Numbers: NEU-04.15
First Posted: November 2, 2018    Key Record Dates
Last Update Posted: July 12, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Amantadine
Sinusitis
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Cefpodoxime
Cefpodoxime proxetil
Ceftizoxime
Anti-Bacterial Agents
Anti-Infective Agents
Antiparkinson Agents
Anti-Dyskinesia Agents
Antiviral Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents