Health Condition 1: J019- Acute sinusitis, unspecified
Conditions
Interventions
Intervention1: Nafithromycin: Strength and pharmaceutical dosage form: 400 mg tablet
Dose: 400 mg once daily on Day 1 through Day 3
Route of Administration: Oral
Control Intervention1: Amoxicillin-cla
Sponsors
Ms Wockhardt Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male or female greater than equal to 18 years of age 2. Willing to participate in the study and provide written informed consent before any protocol-specific assessment is performed. 3. Clinical diagnosis of ABRS in accordance with the guidelines of the Infectious Disease Society of America (IDSA), i.e., fitting into one of 3 categories. The 3 IDSA categories are Persistent symptoms of rhinitis, purulent secretions, and/or pain in the face or teeth without improvement (lasting for greater than equal 10 days), OR Severe symptoms or signs of fever of at least 102 F and nasal discharge or facial pain (lasting for greater than equal 3 to 4 days), OR Worsening symptoms or signs characterized by a new onset of fever, headache, or increase in nasal discharge following a typical viral upper respiratory illness that lasted 5 to 6 days and was initially improving (double sickening). 4. Trial participants have at least 2 out of 5 symptoms of ABRS mentioned in the ABRS symptom questionnaire such as purulent nasal discharge, blocked nose, facial pain, chills/rigor and pressure around eyes, nose and cheek, forehead. 5. Trial participants have a baseline CT sinus imaging, done not more than 48 hrs prior to randomization and having findings consistent with ABRS. 6. All females must have had a negative urine or serum pregnancy test (beta human chorionic gonadotropin [beta HCG]) at Screening AND agreed to the use of 1 of the following acceptable methods of contraception from Screening through Day 8: surgical sterilization (defined as bilateral oophorectomy or bilateral salpingectomy, but excluding bilateral tubal occlusion), post-menopausal women (defined by amenorrhea for at least 12 months following cessation of all exogenous hormonal treatments), barrier contraception (Example. condom, intrauterine device), levonorgestrel intrauterine system example Mirena, regular medroxyprogesterone injections Example Depo-provera, sexual intercourse with only vasectomized partners or abstinence. 7. All males must have agreed to use an acceptable barrier method of birth control (i.e. condom) with female partner(s) and must not donate sperm from Screening through Day 8. 8. Ability to ingest the intact oral study drug.
Exclusion criteria
Exclusion criteria: 1. Trial participants who have severe infection requiring surgical drainage of sinuses or parenteral antibiotic therapy or needing hospitalization. 2. Presence or known diagnosis of Allergic rhinitis 3. Presence or known diagnosis of Nasal polyposis requiring surgery 4. Suspected or confirmed complications such as preseptal cellulitis, orbital cellulitis, subperiosteal abscess, orbital abscess, cavernous sinus thrombophlebitis, acute mastoiditis, facial palsy and bacterial meningitis in the opinion of Investigator. 5. Trial participants who have received more than a single dose of systemic antibacterial treatment for ABRS within the last 72 hrs, with exception of participants who are not responding to the current antibiotic treatment according to the Investigator. 6. Need of concomitant use of other antibiotics. 7. Chronic or recurrent sinus problems. Defined as persistent symptoms of sinus congestion, not attributed to nasal allergies, for 8 weeks or more or 2 or more episodes of antibiotic-treated sinusitis in past 3 months. 8. Known or suspected sinus fungal or viral cause of infection 9. Presence or history of recent trauma or recent surgery with last 4 weeks. 10. Known to have had Methicillin-resistant Staphylococcus aureus (MRSA) sinus infection within the past month. 11. History of hospitalization in the last 90 days before screening 12. Use of any experimental drug or device within 30 days prior to enrolment 13. History of allergy or intolerance to any penicillin or amoxicillin clavulanate or macrolides and their excipients. 14. History or of hypersensitivity, known contraindication (example. lactose intolerance, lactase deficiency or glucose-galactose malabsorption) or allergic reaction (example. anaphylaxis, urticaria, other significant reaction) to any macrolide or beta-lactam antibiotic or beta-lactamase inhibitor (any of the study drug or its ingredients). 15. Evidence of significant immunologic disease determined by any of the following: Current or anticipated neutropenia defined as less than 500 neutrophils,mm3 History of heart, lung, liver or kidney transplant Receipt of cancer chemotherapy, radiotherapy or potent, non-corticosteroid immunosuppressant drugs (e.g., cyclosporine, azathioprine, tacrolimus, immune-modulating monoclonal antibody therapy) within the past 3 months or receipt of corticosteroids equivalent to or greater than 40 mg of prednisone per day for more than 14 days in the 30 days before randomization. 16. Compromised hepatic or renal function, including but not limited to the following: clinical evidence of end stage liver disease (Example. ascites, hepatic encephalopathy), screening serum total bilirubin greater then 2 times the Upper Limit of Normal ULN (unless associated with an elevated indirect bilirubin typical of Gilbert syndrome), aspartate aminotransferase (AST) or alanine aminotransferase (ALT) greater then or equal to 3 times the ULN, serum creatinine greater than 2.0 mg/dL creatinine clearance less than 50 mL/min or blood urea nitrogen greater then 30 mg/dL; other clinically significant abnormal laboratory findings should be discussed with the Medical Monitor before the enrollment of the trial participants. 17. History of Clostridium difficile-associated disease within 6 months before enrolment. 18. Trial Participants w
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the clinical response rate of oral nafithromycin compared to combination of oral amoxicillin-clavulanic acid and azithromycin at the visit on Day 8.Timepoint: Day 8 | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess the safety of oral nafithromycin treatment. To assess the clinical response at early assessment (EA) visit on Day 4. To assess the clinical outcome at the follow up (FU) Visit on Day 15. Timepoint: Day 4, Day 15 | — |
Countries
India
Contacts
Public ContactDr Sachin Bhagwat
Wockhardt Research Centre
Outcome results
None listed