A Phase IV, Open Label, Multicenter, Interventional Study to Assess the Safety and Efficacy of Oral MIQNAF® (Nafithromycin) as Monotherapy in the Treatment of Adult Patients With Community-Acquired Bacterial Pneumonia (CABP)

Ms Wockhardt Limited23 个研究点分布在 1 个国家目标入组 500 人开始时间: 2025年10月17日最近更新: 2026年3月11日

试验速览

阶段: 4 期
状态: 招募中
发起方
入组人数: 500
试验地点: 23
主要终点: To evaluate the safety of 3-day treatment with oral MIQNAF®(Nafithromycin) in adult patients with CABP.

研究概览研究设计入排标准结局指标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 IV, open-label, multicentre, single-arm interventional study in approximately 500 adult patients with Community-Acquired Bacterial Pneumonia (CABP). Eligible participants will receive 3 days of oral antibiotic therapy in the outpatient setting with MIQNAF® (Nafithromycin) 800 mg once daily (administered as two 400 mg tablets) from Day 1 to Day 3. Participants should take the medication at approximately the same time each day, preferably after a meal. CABP symptoms will be assessed at Screening/Baseline, Day 4 (End of Treatment, EOT), Day 7 (±1), and Day 14 (±2) (End of Study, EOS).

研究设计

研究类型: Interventional
分配方式: Na
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

•Adults (more than 18 years) diagnosed with CABP.
•Willing to participate in the study and provide written informed consent before any protocol-specific assessment is performed
•Trial participants must meet the following criteria for CABP: A) Have at least TWO of the following symptoms (new or worsening) Cough Production of purulent sputum Dyspnoea (Shortness of breath) Pleuritic chest pain B) Have at least TWO of the following vital sign abnormalities The presence of fever (within 24 hours prior to enrolment), defined as oral temperature greater than 38°C/100.4°F, or a rectal/core temperature greater than 39°C/102.2°F OR hypothermia (within 24 hours prior to enrolment), core temperature smaller than 35°C/95°F. Hypotension defined as systolic BP smaller than 90 mm Hg Tachycardia defined as heart rate greater than 90 beats per minute Tachypnoea defined as respiratory rate greater than 20 breaths per minute) C) Radiographic evidence of CABP: Radiographically confirmed pneumonia, i.e., new or progressive pulmonary infiltrate(s) on chest Xray or chest computed tomography (CT) scan consistent with bacterial pneumonia within 48 h before receiving the first dose in the study. D) At least one of the following, clinical signs or laboratory findings.
•Hypoxemia defined as arterial O2 saturation smaller than 90% by pulse oximetry or partial pressure of arterial oxygen smaller than 60 mm Hg by arterial gas method. Auscultatory findings on pulmonary examination consistent with bacterial pneumonia or pulmonary consolidation (e.g. crepitations, dullness on percussion, bronchial breath sounds or egophony) Leucocytosis (WBC greater than 10,000 cells/mm3) or leukopenia (WBC smaller than 4000 cells/ mm3). Elevated immature neutrophils (greater than 15% band forms), regardless of total peripherial WBC coumt
•Trial participants are deemed to be fit to receive oral MIQNAF® (Nafithromycin) as per Investigator’s discretion.
•Urine pregnancy test (UPT)/Serum pregnancy test negative at screening visit for women with childbearing potential
•All males must agree 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 7 visit.

排除标准

•Receipt of more than 1 dose of a potentially effective systemic antibacterial treatment for the current CABP within 72 h before enrolment except If the prior therapy is a single dose of a short acting antibacterial agent (Appendix I, Section 27.0) for allowable prior antibiotics).
•Receipt of prior antibiotic therapy and in the Investigators opinion, failed that prior antibiotic therapy (i.e., worsening signs and symptoms)
•Subjects with any of the following confirmed or suspected types of pneumonia: Aspiration pneumonia Hospital-acquired bacterial pneumonia, defined as pneumonia with onset of clinical signs and symptoms after at least 48 h hospitalization in an acute inpatient healthcare facility Healthcare-associated bacterial pneumonia, defined as pneumonia acquired in a long-term care or subacute healthcare facility (e.g. nursing home) or pneumonia with onset after recent hospital discharge (within 90 days of current admission and previously hospitalised for greater than equal to 48 h) Ventilator-associated bacterial pneumonia, defined as pneumonia with onset of clinical signs and symptoms after at least 48 h of endotracheal intubation Pneumonia that may be caused by pathogen(s) resistant to any study drug (nafithromycin), including viral, mycobacterial or fungal pneumonia (e.g. Pneumocystis jiroveci pneumonia, active pulmonary tuberculosis) in the opinion of the investigator.
•Post-obstructive pneumonia Pneumonia associated with cystic fibrosis, bronchiectasis or any other chronic pulmonary disease
•Suspected or confirmed pleural empyema (a parapneumonic pleural effusion is not an exclusion criterion) or lung abscess
•Suspected or confirmed non-infectious causes of pulmonary infiltrates (e.g. pulmonary embolism, hypersensitivity pneumonia, congestive heart failure) Women of childbearing potential not ready to use an effective barrier contraceptive method during the study.
•Pregnant or lactating female.
•Moderate to severe hepatic dysfunction (Child Pugh Category B or C) or renal dysfunction (estimated Glomerular Filtration Rate [eGFR] less than 50 ml/min/1.73m²)
•Screening serum total bilirubin greater than 2 times the upper limit of normal (ULN) (unless elevated indirect bilirubin due to known Gilbert’s syndrome), aspartate aminotransferase (AST) or alanine aminotransferase (ALT) greater than 3 times ULN, or alkaline phosphatase greater than 2 times ULN
•Trial participant with any significant medical / non-medical condition in the opinion of the Investigator that does not allow the participation of the patient in the study.
•Participation in any other clinical trial 30 days prior to screening visit
•History of hypersensitivity to the study drug or similar class of drugs
•History of Clostridium difficile-associated disease within 6 months before enrolment.
•Current peripheral neuropathy or myasthenia gravis
•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 Fridericis formula (QTcF) greater than 450 ms (males) or greater than 470 ms (females) or requirement for medications known to cause QT prolongation.
•Prior (within 14 days before enrollment) or concomitant use of CYP liver enzyme inducers (e.g. phenobarbital, carbamazepine, griseofulvin, sulfonylureas, phenytoin or rifampin)
•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.

结局指标

主要结局

To evaluate the safety of 3-day treatment with oral MIQNAF®(Nafithromycin) in adult patients with CABP.

时间窗: days 4 (EOT), 7 (+1day) and 14 (±2 days) (EOS).

次要结局

To evaluate the efficacy of 3-day treatment with oral MIQNAF (Nafithromycin) in adult patients with CABP(day 4, day 7 and day 14)

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 (23)

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