SinusitisPhase 3NCT03729258
Efficacy and Safety of Modified Release Cefpodoxime Formulation in the Treatment of Acute Sinusitis.
A Phase 3 study testing Infex 400 MR and Infex 200 IR in people with Sinusitis and Sinusitis, Acute, run by Neutec Ar-Ge San ve Tic A.Ş at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sinusitis, Sinusitis, Acute, Rhinosinusitis
- What is being tested?
- Infex 400 MR and Infex 200 IR
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 May 2019to 1 Dec 2023
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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),
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- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Bakırköy Dr. Sadi Konuk Training and Research Hospital
Istanbul
İbrahim Sayın, Assoc Prof Dr
dribrahimsayin@yahoo.com
About this study
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.
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.
- Being tested
- Infex 400 MR, Infex 200 IR
- Medical subject headings
- Sinusitis, Rhinosinusitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Infex 400 MRDrug
Infex (cefpodoxime) 400mg once a day (QD) for 10 days
Infex 200 IRDrug
Infex (cefpodoxime) 200mg twice a day (BID) for 10 days
| Study group | Role | What they receive |
|---|---|---|
| Cefpodoxime 200 (b.i.d) | Experimental | Not described Receives: Drug: Infex 200 IR |
| Cefpodoxime 400 (q.d) | Active comparator | Not described Receives: Drug: Infex 400 MR |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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,
Measured: 10 days
Secondary outcomes (1)
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)
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2018
- Study start15 May 2019
- Primary completion1 Oct 2023 (estimated)
- Study completion1 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SinusitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Neutec Ar-Ge San ve Tic A.Ş
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03729258
- Sponsor's protocol ID
- NEU-04.15
- Status last verified
- Jan 2023
- First submitted
- 22 Oct 2018
- Last updated
- 5 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT03729258
- Acronym / sponsor ID
- NEU-04.15
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Neutec Ar-Ge San ve Tic A.ŞIndustry (pharma, biotech, devices)
- Study start
- 15 May 2019 (actual)
- Primary completion
- 1 Oct 2023 (estimated)
- Study completion
- 1 Dec 2023 (estimated)
- First posted
- 2 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cefpodoxime 200 (b.i.d) | Experimental | Drug: Infex 200 IR |
| Cefpodoxime 400 (q.d) | Active comparator | Drug: Infex 400 MR |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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,
Key exclusion criteria (12 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Infex 400 MRInfex (cefpodoxime) 400mg once a day (QD) for 10 days | Drug | Cefpodoxime 400 (q.d) |
| Infex 200 IRInfex (cefpodoxime) 200mg twice a day (BID) for 10 days | Drug | Cefpodoxime 200 (b.i.d) |
Primary outcome
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,
1 secondary outcome
Evaluation of the safety of investigational products
Time frame: 10 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Infex 400 MR and Infex 200 IR in people with Sinusitis and Sinusitis, Acute, run by Neutec Ar-Ge San ve Tic A.Ş at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Neutec RDC (00905051747902, iremkaraman@neutecrdc.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of formulations on acute sinusitis symptoms (time frame: 10 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2023.