A post marketing study to check safety of Garenoxacin in patients with bacterial respiratory infectio
- Conditions
- Health Condition 1: null- Bacterial Respiratory Tract InfectionHealth Condition 2: J13- Pneumonia due to Streptococcus pneumoniae
- Registration Number
- CTRI/2015/01/005354
- Lead Sponsor
- Glenmark Pharmaceuticals Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 461
1. Male or female subjects, age more than or equal to 18 and less than or equal to 65 years at the time of informed consent.
2. Subjects with clinical signs and symptoms of respiratory tract infections with bacteriological etiology suspected by the Investigator during evaluation in real life clinical settings.
3. Provide written informed consent.
4. Willing and able to comply with all aspects of the study protocol.
• Subjects requiring hospitalization
• Subjects with known or suspected hypersensitivity to fluoroquinolones or any constituents of the formulation.
• Subjects who have received antimicrobial therapy within 7 days prior to enrollment
• Pneumonia acquired in hospital within past 14 days
• Patients with severe complications of RTI or history of hospitalization
• An uncontrolled, unstable clinically significant medical condition
• Neutropenia (less than or equal to 500 PMNs/c.mm), thrombocytopenia (less than 100000 per microlitre
• Clinically significant derangements in alanine transaminase (ALT), aspartate transaminase (AST) ,bilirubin or other laboratory parameters
History of Cardiac arrthymias and CNS disorders
• Pregnant and/or lactating women.
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence of treatment emergent adverse events (AEs)Timepoint: For the entire duration of the study
- Secondary Outcome Measures
Name Time Method ATimepoint: NA