Health Condition 1: null- Bacterial Respiratory Tract Infection Health Condition 2: J13- Pneumonia due to Streptococcus pneumoniae
Conditions
Interventions
Intervention1: Garenoxacin 200 mg: Two tablets of Garenoxacin 200 mg, (i.e. 400mg) will be prescribed once a day in the morning after food for 5 to 14 days. Route of administration is oral route.
Cont
Sponsors
Glenmark Pharmaceuticals Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: • 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of treatment emergent adverse events (AEs)Timepoint: For the entire duration of the study | — |
Secondary
| Measure | Time frame |
|---|---|
| NATimepoint: NA | — |
Countries
India
Contacts
Public ContactDr K Krishnaprasad
Glenmark Pharmaceuticals Ltd.
Outcome results
None listed