CTRI/2019/11/021964 [Registered on: 11/11/2019] Trial Registered Prospectively
Last Modified On:
11/10/2023
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Drug
Study Design
Randomized, Parallel Group, Active Controlled Trial
Public Title of Study
clinical trial of oral nafithromycin in in the Treatment of Community-Acquired Bacterial Pneumonia (CABP) in Adults
Scientific Title of Study
A Phase III, Randomised, Multicentre, Double-Blind, Comparative Study to Determine the Efficacy and Safety of Oral Nafithromycin Versus Oral Moxifloxacin in the Treatment of Community-Acquired Bacterial Pneumonia (CABP) in Adults
Accord Hospital (Unit of Sant Dnyaneshwar Hospital Pvt. Ltd.),
Plot No. 1, Spine Road, Santa Nagar, Moshi Pradhikaran,
Sector Number 4, Moshi, Pimpri-Chinchwad,
Maharashtra – 411070 Pune MAHARASHTRA
9004031468
amolmisal@yahoo.com
Dr Suninder Singh Arora
Batra Hospital and Medical Research Centre
Room No G-15 B-Block, Department of Medicine and Critical Care Medicine, Batra Hospital& Medical Research Centre, 1, Tughlakabad Institutional Area, Mehrauli Badarpur Road,New Delhi-110 062 (Near Saket Metro Station) South DELHI
9810113414
drssarora@gmail.com
Dr Jugal B Gupta
Eternal Hospital
Eternal Hospital, Unit of Eternal Heart Care Centre & Research Institute Pvt, Ltd. 3A, Jagatpura Road, Near Jawahar Circle,302017, India Jaipur RAJASTHAN
9829414680
drjbgupta@gmail.com
Dr Saurabh Agarwal
Ganesh Shankar Vidyarthi Memorial (GSVM) Medical College
Post Graduate Department of Medicine, Room no.08, ground floor, Ganesh Shankar Vidyarthi Memorial (GSVM) Medical College, Swaroop Nagar, Kanpur, 208002 (Uttar Pradesh) Kanpur Nagar UTTAR PRADESH
9415039582
dragarwalsaurabh@gmail.com
DrAnand Patel
GMERS Medical College and General Hospital
Clinical Research room, 6th floor, Department of Medicine, Hospital Building, GMERS Medical College and general hospital , Gotri, Vadodara 390021, Gujarat India Vadodara GUJARAT
9879771079
dranandkpatel@gmail.com
Dr Himanshu Pophale
Jeevandhara Multispecialty Hospital
Building Sr.no.84/2-D, 1st Floor, Bhagirathi square, Morebaug Road, Katraj, Pune, Maharashtra 411046 Pune MAHARASHTRA
7588693308
himanshupophale@yahoo.co.in
Dr Sumaiya Anjum
K.R.Hospital,Mysore Medical College
Department of medicine, first floor, K.R.Hospital, Mysore Medical College and Research Institute Irwin Road,Mysuru-570001,Karnataka,India Mysore KARNATAKA
7760218464
sumi_anjum262@yahoo.com
Dr Sumer Sanjiv Choudhary
NKP Salve Institute
NKP Salve Institute of Medical
Sciences & Research Centre Lata Mangeshkar Hospital, Digdoh hill,
Hingna road Nagpur. Pin-440019.
MAHARASHTRA
Nagpur MAHARASHTRA
Jambhe Road, Near Khandoba
Temple, Vishnu Dev Nagar, Punawale, Pune, Maharashtra 411033 Pune MAHARASHTRA
9028560535
Nikalje.rajkumar@gmail.com
Dr Anjali Khalane
Saikrupa Hospital
Renuka Corner, Tapkir Chowk, Chest OPD, Thergaon, 411033, India Pune MAHARASHTRA
7798382852
anjaliparhar@gmail.com
Dr Vinay Bhomia
Sanjivani Super Speciality Hospital
Sanjivani Super Speciality Hospital Pvt Ltd, Ground floor, Room no. 03, New Uday Park Soc, Near Sunrise Park, Vstrapur, Ahmedabed-380015, Gujarat, India Ahmadabad GUJARAT
Shree Giriraj Multi Speciality Hospital, Ground floor OPD department, 27, Navjyot Park Main Road, 150 Feet Ring Road, Rajkot, Gujarat 360005 Rajkot GUJARAT
9879571317
drtspatel@gmail.com
DrAkash Lataru Balki
Shree Hospital and Critical Care Centre
Shree Hospital and Critical Care Centre
799,OM Nagar, Opp. Tajshree Building Sakkardara Sq.
Nagpur-440009 Nagpur MAHARASHTRA
9890812215
akashbalki49@gmail.com
Dr Keyur Brahme
SSG Hospital and Medical College
Clinical study room, second floor, New Emergency Building, SSG Hospital, Medical college Baroda, Vadodara-390001 Vadodara GUJARAT
9727729105
keyurbrahme@gmail.com
Dr Girish Chandrakant Rajadhyaksha
Topiwala National Medical College & B. Y. L. Nair Charitable Hospital
College building, first floor, department of medicine
Topiwala National Medical College & B. Y. L. Nair Charitable Hospital,
Dr. A. L. Nair Road,. Mumbai Cemtral, Mumbai - 400008
Mumbai MAHARASHTRA
800 mg (two 400-mg tablets) orally (PO) every 24 hours (q24h) for 3 days
Inclusion Criteria
Age From
18.00 Year(s)
Age To
90.00 Year(s)
Gender
Both
Details
Meet the following clinical criteria for CABP:
Have at least TWO of the following symptoms (new or worsening):
Dyspnoea (shortness of breath)
Cough
Production of purulent sputum
Pleuritic chest pain
Have at least TWO of the following vital sign abnormalities:
Fever or hypothermia documented by the Investigator (oral, rectal or tympanic temperature > 38.0°C [100.4°F] or < 36.0°C [95.5°F])
Hypotension, defined as systolic blood pressure < 90 mmHg
Tachycardia, defined as heart rate > 90 beats per minute
Tachypnoea, defined as respiratory rate > 20 breaths per minute
Have at least ONE of the following clinical signs or laboratory abnormalities:
Hypoxaemia defined as arterial oxygen saturation < 90% by pulse oximetry or partial pressure of arterial oxygen < 60 mmHg by arterial blood gas
Auscultatory findings on pulmonary examination consistent with bacterial pneumonia or pulmonary consolidation (e.g. rales, dullness on percussion, bronchial breath sounds or egophony)
Elevated total white blood cell (WBC) count (> 10,000 cells/mm3) or leucopenia (WBC < 4000 cells/mm3)
Elevated immature neutrophils (> 15% band forms), regardless of total peripheral WBC count
dRadiographic evidence of CABP:
Radiographically confirmed pneumonia, i.e., new or progressive pulmonary infiltrate(s) on chest X-ray or chest computed tomography scan consistent with acute bacterial pneumonia within 48 h before randomisation
PORT score of 51 to 105 (PORT Risk Class of II, III or IV)
All females must have a negative urine or serum pregnancy test (beta human chorionic gonadotropin) at Screening AND agree to the use of 1 of the following acceptable methods of contraception from Screening through TOC
All males must agree to use an acceptable barrier method of birth control
ExclusionCriteria
Details
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 hospitalisation 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 ≥ 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, moxifloxacin), including viral, mycobacterial or fungal pneumonia (e.g. Pneumocystis jiroveci pneumonia, active pulmonary tuberculosis)
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)
Receipt of 1 or more dose(s) of a potentially effective systemic antibacterial treatment for treatment of the current CABP within 72 h before randomisation except if the prior therapy is a single dose of a short-acting antibacterial agent ; subjects requiring concomitant adjunctive or additional potentially effective systemic antibacterial treatment for management of CABP
Evidence of significant immunologic disease
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
On-site computer system
Blinding/Masking
Double Blind Double Dummy
Primary Outcome
Outcome
TimePoints
To demonstrate that oral nafithromycin is non-inferior to oral moxifloxacin in the clinical response at Day 4 in the Modified Intent to Treat (MITT) analysis set
• To assess overall safety of oral nafithromycin in the safety analysis set
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Brief Summary
This is a Phase III, prospective, multicentre,
randomised, double-blind, comparative efficacy and safety study of oral
nafithromycin versus oral moxifloxacin for the treatment of male and female
adults with CABP. Subjects providing informed consent and meeting all study
eligibility criteria will be enrolled in the study and randomised in a 1:1
ratio to either of the following 2 treatment arms