Prescription Event Monitoring (PEM) for EMROK tablet and Injections
Not Applicable
- Conditions
- Health Condition 1: A488- Other specified bacterial diseases
- Registration Number
- CTRI/2021/08/035789
- 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 patients of any gender who have been prescribed with EMROK® or EMROK â?? O® by their treating physicians can be part of this prescription event monitoring surveillance
Exclusion Criteria
1. Known to be hypersensitive to Levonadifloxacin and any other quinolone antibactrial or to any other excepients
2. Patients having history of Tendon disorders
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To evaluate safety and efficacy of EMROK® (Levonadifloxacin injection) &/or EMROK â?? O® (Levonadifloxacin tablet) in real world settingTimepoint: Day 1, Day 3 and Day 8
- Secondary Outcome Measures
Name Time Method Clinical Success rate <br/ ><br>Microbiological Success rate <br/ ><br>Overall Global Assessment for Efficacy <br/ ><br>Overall Global Assessment for Safety <br/ ><br>Usage of EMROK Treatment <br/ ><br>Incidence of Adverse events <br/ ><br>Timepoint: Day 1 <br/ ><br>Day 3 and <br/ ><br>Day 8