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

Primary Purpose

Sinusitis, Sinusitis, Acute, Rhinosinusitis

Status
Recruiting
Phase
Phase 3
Locations
Turkey
Study Type
Interventional
Intervention
Infex 400 MR
Infex 200 IR
Sponsored by
Neutec Ar-Ge San ve Tic A.Ş
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sinusitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Bakırköy Dr. Sadi Konuk Training and Research HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Cefpodoxime 200 (b.i.d)

Cefpodoxime 400 (q.d)

Arm Description

Outcomes

Primary Outcome Measures

Effect 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.
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).
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,

Secondary Outcome Measures

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)

Full Information

First Posted
October 22, 2018
Last Updated
January 4, 2023
Sponsor
Neutec Ar-Ge San ve Tic A.Ş
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1. Study Identification

Unique Protocol Identification Number
NCT03729258
Brief Title
Efficacy and Safety of Modified Release Cefpodoxime Formulation in the Treatment of Acute Sinusitis.
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.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 15, 2019 (Actual)
Primary Completion Date
October 1, 2023 (Anticipated)
Study Completion Date
December 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Neutec Ar-Ge San ve Tic A.Ş

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sinusitis, Sinusitis, Acute, Rhinosinusitis, Rhinosinusitis Acute, Sinus Infection

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cefpodoxime 200 (b.i.d)
Arm Type
Experimental
Arm Title
Cefpodoxime 400 (q.d)
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Infex 400 MR
Intervention Description
Infex (cefpodoxime) 400mg once a day (QD) for 10 days
Intervention Type
Drug
Intervention Name(s)
Infex 200 IR
Intervention Description
Infex (cefpodoxime) 200mg twice a day (BID) for 10 days
Primary Outcome Measure Information:
Title
Effect of formulations on acute sinusitis symptoms
Description
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
Title
Effect of formulations on quality of life scale
Description
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
Title
Rate of microbiological response at the end of treatment
Description
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
Secondary Outcome Measure Information:
Title
Evaluation of the safety of investigational products
Description
Number of Adverse Events That Are Related to Treatments and Participants with Abnormal Laboratory Values (hemogram, sedimentation, CRP)
Time Frame
10 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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) 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]). Patients who are able to use oral drugs, If patient is a women of childbearing age; female patients who applies appropriate birth control, Patients who have ability to communicate with investigators, Patients who commits to adhere to the study protocol, Patients who sign informed consent form. Exclusion Criteria: Patients who have hypersensitivity to beta-lactam antibiotics, penicillin and cefpodoxime, Patients who hypersensitivity to peanut and soy, Patients who have kidney or liver deficiency, Patients who have history of more than 2 bacterial sinusitis episode within last 12 months, Patients who have chronic sinusitis, Patients who have history of head and neck surgery and/or severe sinusitis complication (brain abscess or venous thrombosis), Patients who are hospitalized within 4 weeks prior to the start of study, Patients who have immunodeficiency (i.e; HIV, corticosteroid use, immunosuppressive use), Patients who used antibiotics within 30 days prior to the start of study, Patients who need to use of antibiotics other than investigational drugs for concomitant disease, Patients who used aluminium and magnesium containing anti-acids, probenecid and iron containing drugs within 2 weeks prior to the start of study, Pregnant and lactating female patients.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Neutec RDC
Phone
00905051747902
Email
iremkaraman@neutecrdc.com
Facility Information:
Facility Name
Bakırköy Dr. Sadi Konuk Training and Research Hospital
City
Istanbul
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
İbrahim Sayın, Assoc Prof Dr
Email
dribrahimsayin@yahoo.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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