Efficacy and safety of Levonadifloxacin versus Teicoplanin-Azithromycin combination in hospitalized patients with Community Acquired Bacterial Pneumonia (CABP)
- Conditions
- Health Condition 1: J159- Unspecified bacterial pneumonia
- Registration Number
- CTRI/2022/05/042613
- Lead Sponsor
- Dr Anand Nikalje
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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 < 36 C (95.5° 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Clinical success rate at TOC (Test of Cure) visitTimepoint: Day 7±1 to 14 from initiation of therapy
- Secondary Outcome Measures
Name Time Method Clinical success rate at EOT (End of Treatment) visit i.e. Day 7±1 to 14 <br/ ><br>Clinical improvement rate at visit 2 (Early Assessment visit) i.e. Day 4±1 from initiation of therapy <br/ ><br>Microbiological success rate at EOT (End of Treatment) visit <br/ ><br>Safety â?? Tolerability Endpoint: Incidence of adverse events / serious adverse events, Incidence of Nephrotoxicity & Incidence of Thrombocytopenia <br/ ><br>Timepoint: Day 7±1 to 14 <br/ ><br>Day 4±1 from initiation of therapy <br/ ><br> <br/ ><br>Throughout the study <br/ ><br>