Clinical trial NCT03729258: 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
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Sinusitis
Sinusitis, Acute
Rhinosinusitis
Rhinosinusitis Acute
Sinus Infection
Lead sponsor: Neutec Ar-Ge San ve Tic A.Ş
Sponsor class: INDUSTRY
First posted: 2018-11-02
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Effect of formulations on acute sinusitis symptoms
timeFrame: 10 days
measure: Effect of formulations on quality of life scale
timeFrame: 10 days
measure: Rate of microbiological response at the end of treatment
timeFrame: 10 days
Secondary outcomes:
measure: Evaluation of the safety of investigational products
timeFrame: 10 days
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Bakırköy Dr. Sadi Konuk Training and Research Hospital
Study officials:
References: