Health Condition 1: J159- Unspecified bacterial pneumonia
Conditions
Interventions
Intervention1: Levonadifloxacin Injection 800 mg
: Levonadifloxacin IV 800 mg will be administered twice in a day 11±1 hours apart. One dose of IP will be infused over a period of approximately 90 m
Sponsors
Dr Anand Nikalje
Eligibility
Inclusion criteria
Inclusion criteria: Adult subjects of any gender >=18 years Subjects must be willing to participate in the study and provide a written informed consent Subjects with diagnosed CABP (requiring hospitalization) characterized by At least two of the following Cough Production of purulent sputum Dyspnea (shortness of breath) Pleuritic chest pain At least two of the following Fever or hypothermia temperature > 38° C (100.4° F) or Hypotension with systolic blood pressure (SBP) Heart rate > 90 beats/min Respiratory rate (RR) > 20 breaths/min At least one of the following Hypoxemia {partial pressure of arterial oxygen (PaO2)} Physical examination findings of pulmonary consolidation (e.g. dullness on percussion, bronchial breath sounds or egophony) An elevated total white blood cell (WBC) count ( >12,000 cells/mm3) or leucopenia (WBC Radiographically confirmed pneumonia, i.e. new or progressive pulmonary infiltrate on chest X-ray (CXR) or chest computed tomography (CT) scan consistent with bacterial pneumonia PSI - PORT Risk Class > II
Exclusion criteria
Exclusion criteria: The Patients must not meet any the following criteria: Subjects with history of hypersensitivity to any of the study drugs or same class of drugs Subject who have received prior Azithromycin therapy for the treatment of a current episode of CABP. Subjects who have received prior antibiotic therapy within the past 24 hours for the treatment of a current episode of CABP. Following are the exception to these criteria: Subjects who have received a single dose of short acting antibacterial drug within 24 hours of enrolment Subjects with evidence of clinical progression of CABP while on antibacterial drug therapy after at least 48 hours Subjects who have received an antibacterial drug for surgical prophylaxis and subsequently developed CABP Subjects who received any experimental drug within 30 days prior to enrolment Subjects who, in the judgment of the Investigator, are likely to be noncompliant or uncooperative during the study Subjects with any abnormality that the Investigator deems to be clinically relevant, either on medical history, systemic examination or ECG Subjects on hemodialysis or creatinine clearance Subjects with abnormal platelet count
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical success rate at TOC (Test of Cure) visitTimepoint: Day 7±1 to 14 from initiation of therapy | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical success rate at EOT (End of Treatment) visit i.e. Day 7±1 to 14 Clinical improvement rate at visit 2 (Early Assessment visit) i.e. Day 4±1 from initiation of therapy Microbiological success rate at EOT (End of Treatment) visit Safety â?? Tolerability Endpoint: Incidence of adverse events / serious adverse events, Incidence of Nephrotoxicity & Incidence of Thrombocytopenia Timepoint: Day 7±1 to 14 Day 4±1 from initiation of therapy Throughout the study | — |
Countries
India
Contacts
Public ContactDr Khokan Debnath
Wockhardt Ltd.
Outcome results
None listed