A Prospective, Open label, Randomized, Comparative, Two arm, Multi-centric, Investigator initiated study to evaluate efficacy and safety of Levonadifloxacin with Teicoplanin-Azithromycin combination in hospitalized patients with Community Acquired Bacterial Pneumonia (CABP)

Dr Anand Nikalje0 个研究点目标入组 0 人开始时间: 待定最近更新: 2023年3月6日

试验速览

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•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
•Production of purulent sputum
•Dyspnea (shortness of breath)
•Pleuritic chest pain
•At least two of the following
•Fever or hypothermia temperature > 38Â° C (100.4Â° F) or < 36 C (95.5Â° F).
•Hypotension with systolic blood pressure (SBP) < 90 mmHg.
•Heart rate > 90 beats/min
•Respiratory rate (RR) > 20 breaths/min
•At least one of the following
•Hypoxemia {partial pressure of arterial oxygen (PaO2)} < 60 mmHg by arterial blood gas (ABG)
•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 < 4000 cells/mm3)
•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

•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 <= 30 mL/min (estimated by Cockcroft Gault equation).
•Subjects with abnormal platelet count < 1,50,000 cells/mm3

发起方

Dr Anand Nikalje