CTRI

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CTRI Number

CTRI/2026/03/107165 [Registered on: 30/03/2026] Trial Registered Prospectively

Last Modified On:

02/09/2026

Post Graduate Thesis

No

Type of Trial

Interventional

Type of Study

Drug

Study Design

Randomized, Parallel Group, Active Controlled Trial

Public Title of Study

A study evaluating the efficacy and safety of Delafloxacin in comparison to Levofloxacin in patients with severe community acquired bacterial pneumonia

Scientific Title of Study

A Prospective, Multicenter, Randomized, Open Label, Active-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Delafloxacin (Injection and Tablets) in comparison to Levofloxacin (Injection and Tablets) in patients with Severe Community Acquired Bacterial Pneumonia

Trial Acronym

NIL

Secondary IDs if Any

Secondary ID	Identifier
ICR/25/010 Version No. 2.0 Dated 21/NOV/2025	Protocol Number

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	Dr Pravin Ghadge
Designation	Associate Vice President Head India Clinical Research
Affiliation	Sun Pharma Laboratories Limited
Address	Sun House Plot No 201 B1 Western Express Highway Goregaon E Mumbai MAHARASHTRA 400063 India
Phone	9819767704
Fax
Email	pravin.ghadge@sunpharma.com

Details of Contact Person
Scientific Query

Name	Dr Dipesh Sonawane
Designation	Deputy General Manager Medical Affairs & Clinical Research
Affiliation	Sun Pharma Laboratories Limited
Address	Sun House Plot No 201 B1 Western Express Highway Goregaon E Mumbai MAHARASHTRA 400063 India
Phone	7071570717
Fax
Email	Dipesh.Sonawane@sunpharma.com

Details of Contact Person
Public Query

Name	Vidya Sethumadhavan
Designation	Senior Project Manager Medical Affairs Clinical Research
Affiliation	Sun Pharma Laboratories Limited
Address	Sun House Plot No 201 B1 Western Express Highway Goregaon E Mumbai MAHARASHTRA 400063 India
Phone	9920484621
Fax
Email	Vidya.Sethumadhavan@sunpharma.com

Source of Monetary or Material Support

Sun Pharma Laboratories Limited (SPLL), Sun House, Plot No. 201, B/1, Western Express Highway, Goregaon (E), Mumbai-400063, Maharashtra, India

Primary Sponsor

Name	Sun Pharma Laboratories Limited (SPLL)
Address	Sun House Plot No 201 B1 Western Express Highway Goregaon E
Type of Sponsor	Pharmaceutical industry-Indian

Details of Secondary Sponsor

Name	Address
Sun Pharma Laboratories Limited SPLL	Sun Pharma Laboratories Limited, Sun Pharma Advanced Research Centre (SPARC), Tandalja, Vadodara390012, Gujarat, Tel.: (91-265) 6615500 Fax: (91-265) 2354897

Countries of Recruitment

India

Sites of Study
Modification(s)

No of Sites = 30
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Dr Vijay Hadda	All India Institute Of Medical Sciences	AIIMS, Room No. 8, 3 Rd Floor Porta-Cabin, New Private Ward Block, Department Of Pulmonary, Critical Care & Sleep Medicines Ansari Nagar New Delhi – 110029-India New Delhi DELHI	09868883208 Vijayhadda@Yahoo.com
Dr Nisha Ganga	Chettinad Health City Rajiv Gandhi	salai Kelambakkam Chengalpattu Tamil Nadu 60310 Viluppuram TAMIL NADU	9940115194 nisha.prejit@gmail.com
Dr Mohit Agarwal	Chirayu Hospital	Department of Pulmonology Ground Floor Chirayu Hospital Kalwar Road Hathoj Jaipur 302012 Jaipur RAJASTHAN	9913908645 crchirayuhospital@gmail.com
Dr Ajay Kumar	Dr Ram Manohar Lohia Institute of Medical Sciences	Vibhuti Khand Gomti Nagar Lucknow 226010 Lucknow UTTAR PRADESH	9919788862 drajay21@gmail.com
Dr Amit Gupta	Geetanjali Medical Collage and Hospital	4th floor, OPD room, Geetanjali Medical Collage and Hospital Hiranmagri Extension, Manwakhera NH-8 Bypass, Near Eklingpura Chouraha Rajasthan 313001 Udaipur RAJASTHAN	8758181614 amitgupta2486@gmail.com
Dr Maheshkumar Vaghani	Global Super specialty and Cancer hospital	Global Super specialty and Cancer hospital Block No 108 Old survey no 111 EMERALD Avenue Near to irrigation colony Surat Kamrej Road valak char rasta Surat 394180 Gujarat Surat GUJARAT	9825433984 drmahesh11vaghani@gmail.com
Dr Raghumanda Sunil Kumar	Government Hospital for Chest And Communicable Diseases	Department Of Pulmonology Andhra Medical Collage, Pedda Waltair, Visakhapatnam-530017, Andhra Pradesh, India Visakhapatnam ANDHRA PRADESH	9849126543 Drrsunilkumarresearch@Gmail.Com
Dr Arulkumaran P	Government Medical College and HospitaL	Omandurar Govt Estate,169, Wallajah road, Police quarters, Triplicane, Chennai-600002, Tamil Nadu Chennai TAMIL NADU	9940114153 arulkumaranp75@yahoo.in
Dr Gaddam Venkata Mohan	Great Eastern Medical School Hospital	Ragolu Srikakulam Andhra Pradesh 532484 India Srikakulam ANDHRA PRADESH	9390387908 gvenkatamohanresearch@gmail.com
Dr Avdhesh Kumar	GSVM Medical College	Ground Floor Room No 16 Department of Pulmonology GSVM Medical College Swaroop Nagar Kanpur 208002 UP India Kanpur Nagar UTTAR PRADESH	7408441544 dravikumar1001@gmail.com
Dr Bhim Ram	Indira Gandhi Institute Of Medical Sciences	Sheikhpura, Patna Patna Bihar - 800014 India Patna BIHAR	9431042157 Bhimdr42197@Gmail.Com
Dr Rajesh Kumar Chawla	Indraprastha Apollo Hospital	Sarita Vihar, Mathura Road, New Delhi-110076 New Delhi DELHI	9810033395 Crticaretimes@Gmail.com
Dr Rahul Gupta	Jaipur National University Institute for Medical Sciences and Research Centre	Near New Rto Office, Agra Road, Jagatpura, Jaipur, Rajasthan,302017 Jaipur RAJASTHAN	9257036514 Drrahulguptajnu@Gmail.Com
Dr Neeraj Gupta	Jawahar Lal Nehru Medical College	Jawahar Lal Nehru Medical College Kala Bagh Ajmer 305001 Rajasthan India Ajmer RAJASTHAN	9829101942 drneerajajmer@yahoo.com
Dr Huliraj N	Kempegowda Institute of Medical Sciences Hospital Research Centre	Kempegowda Institute of Medical Sciences Hospital Research Centre, KR Road, VV Puram, Bangalore, Karnataka, 560004 Bangalore KARNATAKA	9845291587 kimshuliraj@gmail.com
Dr Hirennappa B Udnur	Medstar Speciality Hospital	641 17 1 3, Kodigehali Main Road, Sahakarnagar, Bangalore-560092, Karnataka, India Bangalore KARNATAKA	9379246563 drhirennappa.medstar@gmail.com
Dr Jaiminkumar Navinchandra Patel	Namostute Hospital	Plot No 1285, Sector 6D, Gh3 Circle Opposite Civil Hospital, Gandhinagar 382006, Gujarat, India Gandhinagar GUJARAT	7016925742 drjaiminpatel119@gmail.com
Dr Pulak Kumar Jana	Nil ratan Sircar Medical College Hospital	Department of Chest Respiratory Medicine 138 AJC Bose Road Kolkata 700014 Kolkata WEST BENGAL	9434326968 pulakjana1971@gmail.com
Dr Samta	Princess Krishnarajammanni Tuberculosis Hospital	Princess Road, KRS Rd Kumbarakoppal, Gokulam, Mysuru, Karnataka 570016 Mysore KARNATAKA	9964070816 drsamta455@gmail.com
Dr Pankaj Magar	Pulse Multispeciality Hospital	sr no 51 7 B 1 1st floor, Vishwa Arcade Opp. Deccan Pavillion Hotel, Mumbai-Bangalore Highway, Narhe Pune Pune MAHARASHTRA	9970126406 drpankajmagar.pulse@gmail.com
Dr Vinod Kumar	Rajiv Gandhi Government General Hospital	Tuberculosis and Respiratory Medicine and Infectious Disease Block GH Post office Poonamallee High Road3 Grand Southern Trunk Road Park Town Near Chennai Central Chennai Tamil Nadu 600003 Chennai TAMIL NADU	9940651858 drvinodkumarv.research@gmail.com
Dr Surendra Kumar	S.P. Medical College & A.G. Of Hospital	Clinical Research Unit, Near Medicine ICU & Maharaj A MRI Department Of Medicine Bikaner - 334001 Rajasthan Bikaner RAJASTHAN	9414604192 Drsurendrakumar@Rediffmail.Com
Dr Monica Gupta	Samvedna Hospital	B 27 88G, New Colony Ravindrapuri Varanasi 221005 Varanasi UTTAR PRADESH	9415336322 monicag4@yahoo.com
Dr Prakash Kurmi	Shivam Hospital	C4 Satyanarayan Society Gor no Kuvo Jasodanagar Char Rasta Maninagar Ahmedabad Gujarat India 380008 Ahmadabad GUJARAT	9825047692 drprakashkurmi@yahoo.co.in
Dr Jagdish Kumar	Shri Mahant Indiresh Hospital	Patel Nagar Dehradun Uttarakhand 248001 India Dehradun UTTARANCHAL	9639212630 drjagdishrawat@yahoo.com
Dr Rohit Bhingardeve	Sneh Sadhana Clinic Sangli	Patrakar Nagar Sangli Maharashtra 416416 Sangli MAHARASHTRA	8080501737 rohit18bhingardeve@gmail.com
Dr Deepti Krishnan	Sri Chamarajendra Hospital Campus	Room No 10A, Department of Respiratory Medicine, 1 Floor, Teaching Hospital Building, Hassan Institute of Medical Sciences, Sri Chamarajendra Hospital Campus, K R Puram, Hassan, Karnataka 573201 Hassan KARNATAKA	9008216765 deeptihere@yahoo.com
Dr Amitabh Das Shukla	Swarooprani Nehru Hospital	Motilal Nehru Medical College Prayagraj Uttar Pradesh India 211002 Allahabad UTTAR PRADESH	9335867395 adshukla1977@yahoo.com
Dr Vulli Venkatesh	Visakha Institute of Medical Sciences	Hanumanthavaka Chinnagadhili Visakhapatnam 530040 Andhra Pradesh India Visakhapatnam ANDHRA PRADESH	9490487605 devvenkateshresearch@gmail.com
Dr Kunjir Nana Gokul	Vishwaraj Hospital	Ground floor department of pulmonology Vishwaraj Hospital Gate no 499 Kadamvakvasti Solapur road Loni kalbhor Pune Maharashtra 412201 India Pune MAHARASHTRA	9962257627 drnana.kunjir@gmail.com

Details of Ethics Committee
Modification(s)

No of Ethics Committees= 30
Name of Committee	Approval Status
CARE IHEC for Faculty Research	Submittted/Under Review
EC Horizon Multispeciality Hospital	Submittted/Under Review
Ethics Committee N.R.S Medical college	Submittted/Under Review
Ethics Committee of Pulse Multispecialty Hospital	Approved
Ethics Committee S.P Medical Collage	Approved
Ethics Committee, GSVM Medical College	Submittted/Under Review
Global Super Speciality and cancer Hospital Ethics Committee	Submittted/Under Review
Human Research Ethics Committee	Submittted/Under Review
IEC Momentous Mental Health and Rehabilitation Center	Submittted/Under Review
IEC Viral MultiSuper Speciality Hospital	Submittted/Under Review
IEC, Maharaja Agrasen Hospital	Submittted/Under Review
Institutional Ethics Committee	Approved
Institutional Ethics Committee	Approved
Institutional Ethics Committee King George Hospital	Approved
Institutional ethics Committee	Approved
Institutional Ethics Committee	Approved
Institutional Ethics Committee	Submittted/Under Review
Institutional Ethics Committee	Submittted/Under Review
Institutional ethics Committee	Submittted/Under Review
Institutional Ethics Committee GEMS	Submittted/Under Review
Institutional Ethics Committee Jawahar Lal Nehru Medical College	Submittted/Under Review
Institutional Ethics Committee MLN Medical college	Submittted/Under Review
Institutional Ethics Committee of Maeers Vishwaraj Hospital	Submittted/Under Review
Institutional Ethics Committee, IGIMS	Approved
Institutional Ethics Committee, Visakha Institute Of Medical Sciences	Submittted/Under Review
Institutional Ethics Committee-Clinical Studies	Submittted/Under Review
Institutional Ethics Committee-HIMS	Submittted/Under Review
KIMS Institutional Ethics Committee	Submittted/Under Review
Medstar Speciality Hospital Ethics Committee	Approved
Samvedna Hospital Ethics Committee	Submittted/Under Review

Regulatory Clearance Status from DCGI

Status

Approved/Obtained

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition: J159\|\|Unspecified bacterial pneumonia,

Intervention / Comparator Agent

Type	Name	Details
Intervention	Delafloxacin for Injection 300 mg vial and Delafloxacin Tablets 450 mg	Delafloxacin for Injection 300 mg/vial will be administered as an approx. 1-hour I.V. infusion every 12 hours (± 2 hours) for a minimum of 6 doses with an option to switch to Delafloxacin Tablets 450 mg administered orally every 12 hours (± 2 hours) for the remaining doses. Maximum treatment duration is 10 days (20 doses of delafloxacin injection ±Tablets)
Comparator Agent	• Levofloxacin Solution for Intravenous Infusion 500 mg 100 ml and Levofloxacin Tablets 500 mg • Linezolid I.V. injection 600 mg/300 ml and Linezolid Tablets 600 mg (Only for MRSA positive patients)	Levofloxacin Solution for Intravenous Infusion 500 mg will be administered as an approx. 1-hour I.V. infusion every 24 (± 2 hours) hours for a minimum of 3 active doses with an option to switch to Levofloxacin Tablets 500 mg administered orally every 24 hours (± 2 hours) for the remaining doses. Maximum treatment duration is 10 days (10 doses of Levofloxacin injection ±Tablets) At local investigator discretion, subjects in the Levofloxacin arm with confirmed MRSA, in place of remaining Levofloxacin doses, can receive Linezolid I.V. injection 600 mg administered as an approx. 30 to 120 minutes I.V. infusion every 12 hours (± 2 hours) for a minimum of 6 active doses with an option to switch to Linezolid Tablets 600 mg administered orally every 12 hours (± 2 hours) for the remaining doses. Maximum treatment duration is 14 days (28 doses of Linezolid injection ±Tablets)

Inclusion Criteria

Age From	18.00 Year(s)
Age To	65.00 Year(s)
Gender	Both
Details	1) Patients of either gender with age between 18 to 65 years (both inclusive) and willing to provide written informed consent and comply with protocol requirements. 2) Evidence of acute onset of CABP before hospital-admission or within 48 hours after admission. 3) Presence of lobar, multi-lobar, or patchy parenchymal infiltrate(s) consistent with acute bacterial pneumonia on a lung imaging study within 48 hours before the first dose of study drug 4)PORT Risk Class of III, IV, or V (PSI Score greater than 70). 5)Presence of at least one risk factors for the Multi Drug Resistance organisms 6) In the opinion of the investigator, the subject must be a suitable candidate for possible I.V. to oral switch antibiotic therapy and must also be able to swallow large tablets intact without crushing 7) Women of childbearing potential must have a negative urine pregnancy test prior to Screening and Randomization and agree to use highly effective methods of contraception to prevent pregnancy from study entry till EOS 8) Male patients must have had a successful vasectomy (confirmed azoospermia) or they and their female partners should be practicing highly effective contraception throughout the study period. (Contraception by female partner is not required if she is not a woman of childbearing potential) [No sperm donation is allowed during the study period]

ExclusionCriteria

Details

1) Any infection expected to require other systemic antibacterial agents in addition to study drug
2) Receipt of systemic antibiotic therapy in the 7 days before enrollment.
3) Respiratory infection confirmed or suspected to be secondary to hospital-acquired or ventilator-associated pneumonia at the time of informed consent.

4) Hospitalization for 2 or more days within 90 days prior to the onset of symptoms
5) Intubated or need mechanical ventilation or vasopressor support for septic shock or ICU care at screening visit
6) Patients on ECMO (Extracorporeal membrane oxygenation) or predicted to be on ECMO at screening visit
7) Pre-existing thrombosis or other thromboembolic events (TEEs) within 3 months before screening visit.
8) Pre-existing decompensated heart failure.
9) Known anatomical or pathological bronchial obstruction, or a history of bronchiectasis, or documented Global initiative for chronic Obstructive Lung Disease Stage 4 chronic obstructive pulmonary disease, or a history of post obstructive pneumonia
10) Severely compromised immune system,
11) Patients having significant renal impairment or hepatic impairment
12) Uncorrected hypokalemia, or known uncorrected hypomagnesemia, at the time of enrollment.
13) Ongoing treatment for seizures or untreated history of seizures
14) History of peripheral neuropathy
15) History of tendon damage disorders due to quinolone therapy
16) Known history of myasthenia gravis
17) History of post-antibiotic colitis within the last 3 months
18) Ventricular arrhythmia and or ongoing proarrhythmic conditions such as clinically significant bradycardia, acute myocardial ischemia
19) History of or diagnosed with prolonged QT syndrome,
20) Concomitant use of drugs known to prolong the QT interval,
21) Concomitant use of monoamine oxidases A or B inhibitor agents and adrenergic and serotonergic agents within 2 weeks of screening
22) Patients with known uncontrolled hypertension, pheochromocytoma, carcinoid thyrotoxicosis and rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption
23) Life expectancy of less than 3 months
24) Immediate life-threatening disease
25) Patients diagnosed with HIV, HBV, and HCV infection
26) Any underlying disease e.g. severe cardiac disease, malignancy, or psychiatric disorder that, in the opinion of the investigator, may interfere with the subject’s ability to participate in the study
27) Previous participation in any study of delafloxacin
28) Receipt of an investigational drug within 30 days of randomization
29) Women who are pregnant, nursing, or fertile and not using contraception
30) Known hypersensitivity to study medications Delafloxacin, Levofloxacin, Linezolid or to any of their excipients.

Method of Generating Random Sequence

Stratified randomization

Method of Concealment

On-site computer system

Blinding/Masking

Open Label

Primary Outcome

Outcome	TimePoints
1.Proportion of patients with ECR	96 hours ± 24 hours

Secondary Outcome

Outcome	TimePoints
Proportion of Clinical Responders at EOT	[Timeframe: Day 5 to Day 10]
Proportion of Clinical Responders at TOC	[Timeframe: Day 10 to Day 20]
Proportion of patients with ECR in mITT population	[Timeframe: 96 hours ± 24 hours]
Proportion of Microbiological Responders at TOC	[Timeframe: Day 10 to Day 20]
All-cause mortality	[Timeframe: Day 28]
Number & proportion of patients with treatment emergent adverse events (TEAEs) & Serious Adverse Events (SAEs)	[Timeframe: Throughout study duration]
Proportion of patients with Adverse Events of Special Interest (AESI)	[Timeframe: Throughout study duration]

Target Sample Size

Total Sample Size="234"
Sample Size from India="234"
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 3

Date of First Enrollment (India)

14/04/2026

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="0"
Months="0"
Days="28"

Recruitment Status of Trial (Global)

Not Applicable

Recruitment Status of Trial (India)

Not Yet Recruiting

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 prospective, multicenter, randomized, open-label, active-controlled, Phase 3 non-inferiority study to be conducted at approximately 20–30 centers across India, following approval from Regulatory Authorities and Ethics Committees.

The study evaluates the efficacy and safety of a structured intravenous (IV) to oral switch strategy using delafloxacin versus levofloxacin in adult patients with confirmed severe community-acquired pneumonia (CAP). Initial IV therapy is required to ensure rapid therapeutic levels and clinical stabilization; however, early transition to oral therapy after clinical improvement offers benefits such as reduced hospital stay, lower healthcare costs, improved patient comfort, and reduced IV catheter-related complications.

An open-label design is appropriate to support on-site clinical decision-making, particularly regarding IV-to-oral switch timing, oral tolerability, and microbiological results. In the levofloxacin arm, if methicillin-resistant Staphylococcus aureus (MRSA) is identified, predefined protocol-guided initiation of linezolid (IV and oral) will be implemented.

Following informed consent, screening assessments will be completed within 24 hours. Baseline evaluations include chest imaging within 48 hours prior to dosing, medical history, physical examination, laboratory tests, and respiratory and blood cultures within 24 hours prior to the first dose. Only subjects classified as PORT Risk Class III, IV, or V will be enrolled. Microbiological identification will be performed using rapid and/or conventional methods as per local availability. Investigator decisions regarding subject continuation will be based on clinical judgment.