CTRI/2025/09/094570
Recruiting
Phase 4
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 sites in 1 country500 target enrollmentStarted: October 17, 2025Last updated:
Overview
- Phase
- Phase 4
- Status
- Recruiting
- Sponsor
- Ms Wockhardt Limited
- Enrollment
- 500
- Locations
- 23
- Primary Endpoint
- To evaluate the safety of 3-day treatment with oral MIQNAF®(Nafithromycin) in adult patients with CABP.
Overview
Brief Summary
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).
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Masking
- None
Eligibility Criteria
- Ages
- 18.00 Year(s) to 90.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
To evaluate the safety of 3-day treatment with oral MIQNAF®(Nafithromycin) in adult patients with CABP.
Time Frame: days 4 (EOT), 7 (+1day) and 14 (±2 days) (EOS).
Secondary Outcomes
- To evaluate the efficacy of 3-day treatment with oral MIQNAF (Nafithromycin) in adult patients with CABP(day 4, day 7 and day 14)
Investigators
Study Sites (23)
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