To evaluate the safety and efficacy of Emrok tablet and Emrok Injection by the surveillance study.
Phase 4
- Conditions
- Health Condition 1: A488- Other specified bacterial diseases
- Registration Number
- CTRI/2023/09/057485
- Lead Sponsor
- Wockhardt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Adult (at least 18 years of age) patient of any gender prescribed with EMROK or/and EMROK-O and willing to provide written informed consent to share information
Exclusion Criteria
1. Known to be hypersensitive to Levonadifloxacin and any other quinolone antibactrial or to any other excepients
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Clinical success rate will be assessed by Resolution of signs and symptoms without the need for additional antimicrobial agents <br/ ><br>Timepoint: at 2 weeks. <br/ ><br>
- Secondary Outcome Measures
Name Time Method Microbiological Success: absence of pathogen <br/ ><br>Timepoint: at 2 weeks;Overall Global Assessment for Efficacy:Investigator will evaluate global assessment for efficacy based on 5-point Likert scale of excellent, very good, good, satisfactory & poorTimepoint: 2 weeks;Overall Global Assessment for Safety: Investigator will evaluate global assessment for safety based on 5-point Likert scale of excellent, very good, good, satisfactory & poorTimepoint: at 2 weeks