Health Condition 1: M01X- Direct infection of joint in infectious and parasitic diseases classified elsewhere
Conditions
Interventions
Intervention1: NUWOK Injection and NUWOK Tablet: NUWOK Injection (Levonadifloxacin 800mg/100 ml)
NUWOK Tablet 500 mg
Dose: NUWOK Injection 800mg/100ml twice a day.
NUWOK Tab. oral 1000 mg twice a day.
Sponsors
Wockhardt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patient age 18 years or above 18 years. 2. willing to patriciate in the study and provide inform consent. 3. Patients diagnosed with bone and joint infection.
Exclusion criteria
Exclusion criteria: 1. patients with history of hypersensitivity of drug and same class of drug.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1 Understanding the prescription pattern of NUWOK in orthopedic setting 2 Evaluate safety profile of NUWOK in patients under orthopedic setting 3 Incidence of adverse events 4 Overall Global Assessment for Safety Timepoint: day 4 and day 28 or EOT | — |
Secondary
| Measure | Time frame |
|---|---|
| 1 Clinical Success Rate at EOT 2 Clinical Responder Rate / Clinical improvement rate at EOT 3 Clinical Responder Rate / Clinical improvement rate at Early assessment (Day 4±2) 4 Microbiological Success Rate 5 Overall Global Assessment for Efficacy Timepoint: day 4 and day 28 or EOT | — |
Countries
India
Contacts
Public ContactDr Kokhan Debnath
Wockhardt Ltd
Outcome results
None listed