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
- Health Condition 1: - Health Condition 2: null- Bacterial Infections
- Registration Number
- CTRI/2017/11/010388
- Lead Sponsor
- OSOURCE PHARMA LTD
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- 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 infectionsTimepoint: Screening to End of Treatment
- Secondary Outcome Measures
Name Time Method Assessment of Changes in the microbial response in respiratory tract infections <br/ ><br>Incidence and rate of adverse eventsTimepoint: Screening to End of Treatment