CTRI/2025/09/094570 [Registered on: 11/09/2025] Trial Registered Prospectively
Last Modified On:
14/04/2026
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Drug
Study Design
Single Arm Study
Public Title of Study
A Phase IV Study of Oral Nafithromycin for the Treatment of Community-Acquired Bacterial Pneumonia (CABP)
Scientific Title of Study
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)
Trial Acronym
NIL
Secondary IDs if Any
Secondary ID
Identifier
W-4873-401 Version 1.0, dated 3-May-2025
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Designation
Affiliation
Address
Phone
Fax
Email
Details of Contact Person Scientific Query
Name
Dr Sachin Bhagwat
Designation
Chief Scientific Officer, Drug Discovery
Affiliation
Wockhardt Research Centre
Address
Division - Drug Discovery Research
Department- Microbiology D-4
MIDC, Chikalthana
Aurangabad MAHARASHTRA 431006 India
Phone
02406694185
Fax
Email
sbhagwat@wockhardt.com
Details of Contact Person Public Query
Name
Dr Sachin Bhagwat
Designation
Chief Scientific Officer, Drug Discovery
Affiliation
Wockhardt Research Centre
Address
Division - Drug Discovery Research
Department- Microbiology D-4
MIDC, Chikalthana
OPD-5, First Floor, Department of Pulmonology, 16, Dr Vikram Sarabhai Marg, near Panjarapole Cross Road, L Colony, Ambawadi, Ahmedabad, Gujarat 380015
Ahmadabad GUJARAT
9925965133
drvsheth@gmail.com
Dr Prashant Potdar
Accord Hospital
Ground Floor Room No 1, Department of General Medicine, Accord Hospital, Spine Road, Sector No 4, Pune Nashik Highway, Moshi, Alandi - 412105
Pune MAHARASHTRA
9746 8118 3935
Prashantpotdar002@gmail.com
Dr Goli M Venkata Kasiram
Aditya Multi speciality Hospital
1st floor room no 5 department of Pulmonary Medicine D. No: 13-3-52, 3rd Line, Guntavari Thota, Kothapet, Beside Peoples Trauma Hospital, Guntur – 522001 Andhra Pradesh, India Guntur ANDHRA PRADESH
9966083232
kasiram1488@gmail.com
Dr Ramniwas Jalandra
All India Institute Of Medical Sciences Bathinda
Room No 1017, Wing A, Ground Floor, OPD Building, Department of Pulmonary Medicine, Jodhpur Romana, near Giani Zail Singh College, Mandi Dabwali Road, Bathinda - 151001, Punjab
Bathinda PUNJAB
9999493179
drrniwas@gmail.com
Dr Sajal De
All India Institute Of Medical Sciences, (AIIMS)Raipur
Department of Pulmonary Medicine, All India Institute of Medical Sciences, Gate No 4. Ground floor, Great Eastern Ro.Tatibandh, Raipur, Chhattisgarh 492099 Raipur CHHATTISGARH
9337791561
sajalde@yahoo.com
Dr Sandeep Katiyar
Apollo Spectra Hospital ,Apollo Specialty Hospital Pvt. Ltd.
Room No B14 basement, Department of Tuberculosis & Respiratory Medicine, 14/138, Mall Rd, near B.N.S.D Inter College, Chunniganj Chauraha, Chunni Ganj, Permat, Kanpur, Uttar Pradesh 208001.
Kanpur Nagar UTTAR PRADESH
9845587380
skkatiyarin@gmail.com
Dr Santosh Honnavar
Belagavi Institute of Medical Sciences
Ground Floor, Room No 60, Department of Respiratory Medicine, Belagavi Institute of Medical Sciences,
Dr. B R Ambedkar Rd, Sadashiv Nagar,Belagavi, Karnataka-590001
Belgaum KARNATAKA
09964451057
honnavar.santosh@gmail.com
Dr Naveed Nazir Shah
Department of pulmonary medicine Govt, Chest Disease Hospital (GMC)
Room No 1, Ground Floor, OPD Bulding, Department of Pulmonary Medicine Govt, Chest Disease Hospital (GMC), Drogjan, Dalgate, Srinagar - 190001
Srinagar JAMMU & KASHMIR
9419016438
naveednazirshah@yahoo.com
Dr K K Shyamala
Dr. B R Ambedkar Medical College and Hospital
Room No 24B, 2nd floor, OPD Department, Building Pulmonary MedicineDr. B.r. Ambedkar Medical College, 24 Shampura main road, Venkateshpuram, Kadugondanahalli, Bengaluru, Karnataka 560045 Bangalore KARNATAKA
8151994080
shyamalakk@gmail.com
Dr Anjan Jyoti Talukdar
Gauhati Medical College and Hospital
Department of Internal Medicine, 3rd Floor, OPD Building Narakasur Hilltop, Bhangagarh, Guwahati 781032, Assam India Kamrup ASSAM
9954658926
anjan110178@gmail.com
Dr Raghumanda Sunil Kumar
Government Hospital for chest and communicable Diseases
Room No 01, Ground Floor, Department of Respiratory Medicine, Government Hospital for Chest and Communicable Diseases (GHCCD), Pedda Waltair, Visakhapatnam-530017, Andhra Pradesh, India Visakhapatnam ANDHRA PRADESH
9849126543
chestdrsunil@gmail.com
Dr Ved Prakash
King Georges Medical University
Ground Floor,Room No 1, Tuberculosis & Respiratory Diseases, King Georges Medical University Shah Mina Rd, Chowk, Lucknow, Uttar Pradesh 226003 Lucknow UTTAR PRADESH
9415091497
drvedprakash.07@gmail.com
Dr Himanshu Pophale
Kothrud Hospital
1st floor, OPD 1 and 2, Department of Pulmonary Medicine, Kothrud Hospital, Gadiya Estate, Paud Rd, opposite Hill View Park, Bhagya Chintamani Nagar, Guruganesh Nagar, Kothrud, Pune, Maharashtra 411038
Pune MAHARASHTRA
9503939461
himanshupophale@yahoo.co.in
Dr Pankti Naik
Mavjat Multispeciality hospital
Ground Floor, Department of Respiratory Medicine, Mansarovar Lake Road, Jantanagar, Bank Colony, Palanpur, B.K. Gujarat- 385001 Banas Kantha GUJARAT
9023481254
panktinaik31@gmail.com
Dr Bhanu Pratap Singh
Midland Healthcare & Research Center
Ground Floor, Department of Respiratory Medicine, Midland Health Care And Research Centre, B-55 Mandir Marg Mahanagar Lucknow
Lucknow UTTAR PRADESH
9415011669
Bps2159@yahoo.com
Dr Kalpesh Panchal
OHM Hospital
2nd floor Room No 201, Department of Respiratory Medicine, OHM Hospital, 18-19, Ghatlodia Rd, Karmachari Nagar Part-1, Ghatlodiya, Ahmedabad, Gujarat 380061 Ahmadabad GUJARAT
09712199914
kalpesh2434@gmail.com
Dr Aman Ahuja
PGIMS UHS Rohtak
1st floor Room no 129 130 OPD Building Department of Pulmonary and critical care medicine,pt. B D Sharma, PGIMS, Rohtak 124001, Haryana
Rohtak HARYANA
08290470844
aman2027@gmail.com
Dr Anjali Khalane
Saikrupa Hospital
2nd floor OPD no 03, department of Pulmonary Medicine, SaiKrupa Hospital, Renuka Corner, Tapkir Chowk, Thergaon, Pune-411033
Pune MAHARASHTRA
7798382852
drakhalane.research@gmail.com
Dr Monica Gupta
Samvedna Hospital
Ground Floor, Department of Respiratory Medicine, Samvedna Hospital, Durgakund Rd, opp. IP Vijaya Mall, Anandbagh, Bhelupur, Varanasi, Uttar Pradesh 221005 Varanasi UTTAR PRADESH
09807768031
samvednahospitalvns@gmail.com
Dr Prashanth G
Saveetha Medical College and Hospital
Ground floor, Department of Respiratory Medicine, Saveetha Medical College and Hospital, Saveetha Nagar, Thandalam, Chennai- 602105
Chennai TAMIL NADU
9788852770
Prasanthgd@gmail.com
Dr Dinesh Desale
Supe Heart and Diabetes Hospital
Room No 1 and 2, 1st floor, department of General Medicine, Supe Heart and Diabetes Hospital,Gharapure Ghat Rd, near Rungta High School, Ashok Stambh, Raviwar Karanja, Panchavati, Nashik, Maharashtra 422002 Nashik MAHARASHTRA
9762944821
dineshd.supehospital@gmail.com
Dr Vivek Vardhan
Swasa Hospital and Research Centre
1st Floor,Room No 07, Department of Pulmonary Medicine,Swasa Hospital and Research Centre, beside Taj Mahal Hotel,near Narayanguda flyover, Narayanguda, Hyderabad. Hyderabad TELANGANA
8755 2272 7082
Vivekswasa@gmail.com
Dr Hamsraj Alva
Vinaya Hospital and Research Centre (A unit of KIMS)
1st Floor, Department of Pulmonary Medicines, Vinaya Hospital and Research Centre (A unit of KIMS), Karangalpady, Mangalore, Karnataka- 575003. Dakshina Kannada KARNATAKA
09343562622
hamsraj.alva@vhrc.co.in
Dr Vulli Venkatesh
Visakha Institute of Medical Sciences
Ground Floor, Department of Pulmonology, Visakha Institute of Medical Sciences, Hanumanthwaka, Visakhapatnam-530040 Visakhapatnam ANDHRA PRADESH
Strength and pharmaceutical dosage form: 400 mg tablet.
Dose: 800 mg once daily (2 tablets of 400 mg each to be taken together) on Day 1 through Day 3.
Route of Administration: Oral
It is recommended to take Nafithromycin preferably after meal.
Comparator Agent
Not Applicable
Not Applicable
Inclusion Criteria
Age From
18.00 Year(s)
Age To
90.00 Year(s)
Gender
Both
Details
1. Adults (more than 18 years) diagnosed with CABP.
2. Willing to participate in the study and provide written informed consent before any protocol-specific assessment is performed
3. 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
4. Trial participants are deemed to be fit to receive oral MIQNAF® (Nafithromycin) as per Investigator’s discretion.
5. Urine pregnancy test (UPT)/Serum pregnancy test negative at screening visit for women with childbearing potential
6. 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.
ExclusionCriteria
Details
1. 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)
2. 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
3. Suspected or confirmed pleural empyema (a parapneumonic pleural effusion is not an exclusion criterion) or lung abscess
4. 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.
6. Pregnant or lactating female.
7. 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)
8. 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
9. 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.
10. Participation in any other clinical trial 30 days prior to screening visit
11. History of hypersensitivity to the study drug or similar class of drugs
12. History of Clostridium difficile-associated disease within 6 months before enrolment.
13. Current peripheral neuropathy or myasthenia gravis
14. 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.
15. Prior (within 14 days before enrollment) or concomitant use of CYP liver enzyme inducers (e.g. phenobarbital, carbamazepine, griseofulvin, sulfonylureas, phenytoin or rifampin)
16. 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.
Method of Generating Random Sequence
Not Applicable
Method of Concealment
Not Applicable
Blinding/Masking
Open Label
Primary Outcome
Outcome
TimePoints
To evaluate the safety of 3-day treatment with oral MIQNAF®(Nafithromycin) in adult patients with CABP.
days 4 (EOT), 7 (+1day) and 14 (±2 days) (EOS).
Secondary Outcome
Outcome
TimePoints
To evaluate the efficacy of 3-day treatment with oral MIQNAF (Nafithromycin) in adult patients with CABP
day 4, day 7 and day 14
Target Sample Size
Total Sample Size="500" Sample Size from India="500" Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials" Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"
Phase of Trial
Phase 4
Date of First Enrollment (India)
17/10/2025
Date of Study Completion (India)
Applicable only for Completed/Terminated trials
Date of First Enrollment (Global)
Date Missing
Date of Study Completion (Global)
Applicable only for Completed/Terminated trials
Estimated Duration of Trial
Years="1" Months="6" Days="0"
Recruitment Status of Trial (Global)
Not Applicable
Recruitment Status of Trial (India)
Open to Recruitment
Publication Details
N/A
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
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).