Health Condition 1: J159- Unspecified bacterial pneumonia
Conditions
Interventions
Intervention1: 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 (
Sponsors
Sun Pharma Laboratories Limited (SPLL)
Sun Pharma Laboratories Limited SPLL
Eligibility
Inclusion criteria
Inclusion criteria: 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]
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Proportion of patients with ECRTimepoint: 96 hours 24 hours | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of Clinical Responders at EOTTimepoint: [Timeframe: Day 5 to Day 10];Proportion of Clinical Responders at TOCTimepoint: [Timeframe: Day 10 to Day 20];Proportion of patients with ECR in mITT populationTimepoint: [Timeframe: 96 hours 24 hours];Proportion of Microbiological Responders at TOCTimepoint: [Timeframe: Day 10 to Day 20];All-cause mortalityTimepoint: [Timeframe: Day 28];Number & proportion of patients with treatment emergent adverse events (TEAEs) & Serious Adverse Events (SAEs)Timepoint: [Timeframe: Throughout study duration];Proportion of patients with Adverse Events of Special Interest (AESI)Timepoint: [Timeframe: Throughout study duration] | — |
Countries
India
Contacts
Public ContactVidya Sethumadhavan
Sun Pharma Laboratories Limited
Outcome results
None listed