A Clinical Study to Evaluate the Efficacy and Safety of PLENMOXI (Moxifloxacin Intravenous Infusion 0.4% w/v) in the Treatment of Bacterial Infections.â€
- Conditions
- Bacterial Infections
- Registration Number
- CTRI/2017/11/010388
- Lead Sponsor
- UNOSOURCE PHARMA LTD
- Brief Summary
**A Prospective Double blind, Randomized, Active controlled Clinical Study to evaluate the Efficacy and safety of Plenmoxi ( Moxifloxacin Intravenous Infusion 0.4 % w/v ) and Avelox ( Moxifloxacin 400 mg / 250 ml solution for infusion ) in the Treatment of Bacterial Infections. Purpose of the Study :- To Compare the Safety and Efficacy of drug Plenmoxi ( Moxifloxacin Intravenous Infusion 0.4 % w/v ) and Avelox (Moxifloxacin 400 mg / 250 ml solution for infusion ) in the treatment of Bacterial Infections. A Total of 50 subjects are enrolled in the study and followed up for 24 days. the data will be analyzed for Non inferiority with 5 5 significance level and 80 % power for study using SAS . The difference within the groups will be assessed using paired T-test . The Difference between the groups will be assessed using Independent T- Test**
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 50
Male or female 18 years of age or older Evidence of acute onset of CABP with 2 or more of the following symptoms (new or worsening) Cough Production of purulent sputum or change in the character of sputum consistent with bacterial infection Difficulty in breathing Chest pain due to pneumonia and have at least 3 of the following findings: 1.Fever (oral temperature greater than 38.0°C) 2.Hypothermia (oral temperature less than 35.0°C) 3.Tachycardia (heart rate more than 100 beats/min) 4.Tachypnea (respiratory rate more than 18 breaths/min) Hypoxemia (oxygen saturation less than 90% or PaO2 less than 60 mmHg on room air or with subject baseline [pre-CABP under study] supplemental oxygen Clinical evidence of pulmonary consolidation and/or presence of pulmonary rates An elevated white blood cell count (WBC) greater than 10,000/ mm³ or 15% immature neutrophils (bands), regardless of total peripheral WBC count or leukopenia with WBC less than 4500/mm³.
A medical history of significant hypersensitivity or allergic reaction to antibiotics of the quinolone or oxazolidinone class Any infection expected to require other systemic antibiotics in addition to study drug Receipt of systemic antibiotic therapy in the 7 days before enrollment One dose of a single potentially effective, short-acting antibacterial drug or drug regimen for CABP within 24 hours before enrollment is allowed Respiratory infection confirmed or suspected to be secondary to hospital-required or ventilator-associated pneumonia or requires treatment in an intensive care setting, or mechanical ventilation Current or suspected diagnosis of viral, fungal, or aspiration pneumonia, noninfectious causes of pulmonary infiltrates, lung cancer, cystic fibrosis, tuberculosis, empyema (not including sterile parapneumonic effusions) Known anatomical or pathological obstruction or history of bronchiectasis or GOLD Stage 4 COPD or history of post obstructive pneumonia Severely compromised immune system Other exclusions include those described in the safety label for drugs in the quinolone and /or oxazolidinone classes such as QT prolongation, proarrhythmic conditions, concomitant use of drugs known to cause QT prolongation, peripheral neuropathy, tendon disorders, history of myasthenia gravis, liver disease, severe renal disease, seizures and concomitant use of MAO A or B inhibitor agents and adrenergic serotonergic agents Subjects who are having positive serology Pregnant and lactating women.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Assessment of changes in Clinical Evaluation in respiratory tract infections Screening to End of Treatment
- Secondary Outcome Measures
Name Time Method Assessment of Changes in the microbial response in respiratory tract infections Incidence and rate of adverse events
Trial Locations
- Locations (1)
Sri Venkateshwara Hospital
🇮🇳Bangalore, KARNATAKA, India
Sri Venkateshwara Hospital🇮🇳Bangalore, KARNATAKA, IndiaDr G Sreenivasa KumariPrincipal investigator9448954282srinivasakumari28@gmail.com