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

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.

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 Overview

• Status: Recruiting
• Conditions: Sinusitis; Rhinosinusitis; Sinus Infection; Sinusitis, Acute; Rhinosinusitis Acute
• Intervention / Treatment: Drug: Infex 200 IR; Drug: Infex 400 MR

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Neutec RDC; Phone Number: 00905051747902; Email: iremkaraman@neutecrdc.com

Study Locations

• Turkey
  • Istanbul, Turkey
    • Recruiting
    • Bakırköy Dr. Sadi Konuk Training and Research Hospital
    • Contact: İbrahim Sayın, Assoc Prof Dr
    • Contact: Email: dribrahimsayin@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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).	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,	10 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	10 days

Collaborators and Investigators

• Sponsor: Neutec Ar-Ge San ve Tic A.Ş

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2019
• Primary Completion (Anticipated): October 1, 2023
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: October 22, 2018
• First Submitted That Met QC Criteria: November 1, 2018
• First Posted (Actual): November 2, 2018

Study Record Updates

• Last Update Posted (Actual): January 5, 2023
• Last Update Submitted That Met QC Criteria: January 4, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Paranasal Sinus Diseases; Nose Diseases; Sinusitis; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Peripheral Nervous System Agents; Antiviral Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Dopamine Agents; Antiparkinson Agents; Anti-Dyskinesia Agents; Amantadine
• Other Study ID Numbers: NEU-04.15

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No