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临床试验/CTRI/2025/12/099360
CTRI/2025/12/099360招募中3 期

A Phase III, Randomized, Open-label, Multicenter, Comparative Study to Evaluate the Efficacy, Safety and Tolerability of Oral Nafithromycin (WCK 4873) Versus Combination of Oral Amoxicillin-Clavulanic Acid And Azithromycin in the Treatment of Acute Bacterial Rhinosinusitis (ABRS) in Adults

Ms Wockhardt Limited26 个研究点 分布在 1 个国家目标入组 290 人开始时间: 2025年12月29日最近更新:
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试验速览

阶段
3 期
状态
招募中
发起方
入组人数
290
试验地点
26
研究概览研究设计入排标准研究者研究点记录与标识符相似试验

研究概览

简要总结

This is a Phase III, open-label, multicentre, comparative, interventional study to evaluate the efficacy, safety and tolerability of oral Nafithromycin versus combination of oral Amoxicillin-clavulanic acid and Azithromycin in approximately 290 adult patients with Acute Bacterial Rhinosinusitis (ABRS). The patients will be randomized 1:1 such that they receive oral antibiotic treatment for a duration of 3 days for patients on Nafithromycin 400mg, arm and 5 to 7 days for Amoxicillin-clavulanic acid 625mg and Azithromycin 500 mg arm, in the outpatient setting preferably after a meal. ABRS symptoms will be assessed at Screening/Baseline, Day 4, Day 8 (+1) and 15 (±2).

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 90.00 Year(s)（—）
性别
All

入选标准

  • •Male or female greater than equal to 18 years of age
  • •Willing to participate in the study and provide written informed consent before any protocol-specific assessment is performed.
  • •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).
  • •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.
  • •Trial participants have a baseline CT sinus imaging, done not more than 48 hrs prior to randomization and having findings consistent with ABRS.
  • •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.
  • •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
  • •Ability to ingest the intact oral study drug.

排除标准

  • •Trial participants who have severe infection requiring surgical drainage of sinuses or parenteral antibiotic therapy or needing hospitalization.
  • •Presence or known diagnosis of Allergic rhinitis
  • •Presence or known diagnosis of Nasal polyposis requiring surgery
  • •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.
  • •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.
  • •Need of concomitant use of other antibiotics.
  • •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.
  • •Known or suspected sinus fungal or viral cause of infection
  • •Presence or history of recent trauma or recent surgery with last 4 weeks.
  • •Known to have had Methicillin-resistant Staphylococcus aureus (MRSA) sinus infection within the past month.
  • •Use of any experimental drug or device within 30 days prior to enrolment
  • •History of allergy or intolerance to any penicillin or amoxicillin clavulanate or macrolides and their excipients.
  • •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).
  • •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.
  • •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.
  • •History of Clostridium difficile-associated disease within 6 months before enrolment.
  • •Trial Participants with prior treatment with or concomitant use of CYP liver enzyme inducers (example.
  • •phenobarbital, carbamazepine, griseofulvin, sulfonylureas, phenytoin or rifampin), cancer chemotherapy, radiotherapy or potent, non-corticosteroid immunosuppressant drugs (example.
  • •cyclosporine, azathioprine, tacrolimus or immune-modulating monoclonal antibody therapy) within the past 3 months or have received corticosteroids equivalent to or greater than 40 mg of prednisone per day for more than 14 days in the 30 days before randomization and trial participants who received any experimental drug within 30 days before enrolment.
  • •Current second- or third-degree atrioventricular block or sick sinus syndrome, uncontrolled atrial fibrillation, severe or unstable angina, congestive heart failure, myocardial infarction within 3 months before the Screening visit, clinically significant ECG abnormalities including QT interval corrected for heart rate using Fridericia’s formula (QTcF) greater than 450 ms (males) or greater than 470 ms (females) or requirement for medications known to cause QT prolongation.
  • •Nursing mothers or pregnant females
  • •Require admission to an intensive care unit for any reason, life expectancy of less than 2 months or any concomitant condition that in the opinion of the Investigator is likely to interfere with evaluation of the response of the infection under study, determination of AEs or completion of the expected course of treatment.

研究者

发起方
Ms Wockhardt Limited
申办方类型
Pharmaceutical industry-Indian
责任方
Principal Investigator

研究点 (26)

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