Health Condition 1: A488- Other specified bacterial diseases
Conditions
Interventions
Intervention1: Emrok Injection (Levonadifloxacin 800mg/100ml).: Emrok (Levonadifloxacin 800mg/100ml) Injection.
route of administration: IV will be infused over the period of approx. 90 min.
Study dur
Sponsors
Wockhardt Ltd
Eligibility
Inclusion criteria
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
Exclusion criteria: 1. Known to be hypersensitive to Levonadifloxacin and any other quinolone antibactrial or to any other excepients
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical success rate will be assessed by Resolution of signs and symptoms without the need for additional antimicrobial agents Timepoint: at 2 weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| Microbiological Success: absence of pathogen 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 | — |
Countries
India
Contacts
Public ContactDr Khokan Debnath
Wockhardt Ltd.
Outcome results
None listed