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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03729258
Recruitment Status : Active, not recruiting
First Posted : November 2, 2018
Last Update Posted : May 20, 2019
Sponsor:
Information provided by (Responsible Party):
Neutec Ar-Ge San ve Tic A.Ş

Tracking Information
First Submitted Date  ICMJE October 22, 2018
First Posted Date  ICMJE November 2, 2018
Last Update Posted Date May 20, 2019
Actual Study Start Date  ICMJE May 15, 2019
Estimated Primary Completion Date October 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 2, 2018)
  • 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,
Original Primary Outcome Measures  ICMJE
 (submitted: November 1, 2018)
  • 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. *
  • 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,
Change History Complete list of historical versions of study NCT03729258 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 1, 2018)
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)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety of Modified Release Cefpodoxime Formulation in the Treatment of Acute Sinusitis.
Official Title  ICMJE 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.
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Sinusitis
  • Sinusitis, Acute
  • Rhinosinusitis
  • Rhinosinusitis Acute
  • Sinus Infection
Intervention  ICMJE
  • Drug: Infex 400 MR
    Infex (cefpodoxime) 400mg once a day (QD) for 10 days
  • Drug: Infex 200 IR
    Infex (cefpodoxime) 200mg twice a day (BID) for 10 days
Study Arms  ICMJE
  • Experimental: Cefpodoxime 200 (b.i.d)
    Intervention: Drug: Infex 200 IR
  • Active Comparator: Cefpodoxime 400 (q.d)
    Intervention: Drug: Infex 400 MR
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: November 1, 2018)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 1, 2019
Estimated Primary Completion Date October 1, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Turkey
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03729258
Other Study ID Numbers  ICMJE NEU-04.15
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Neutec Ar-Ge San ve Tic A.Ş
Study Sponsor  ICMJE Neutec Ar-Ge San ve Tic A.Ş
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Neutec Ar-Ge San ve Tic A.Ş
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP