Real world study to evaluate the safety and efficacy of NUWOK tab and Injection in the patients have infection.
Phase 4
- Conditions
- Health Condition 1: M01X- Direct infection of joint in infectious and parasitic diseases classified elsewhere
- Registration Number
- CTRI/2024/04/065903
- 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
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
1. patients with history of hypersensitivity of drug and same class of drug.
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1 Understanding the prescription pattern of NUWOK in orthopedic setting <br/ ><br>2 Evaluate safety profile of NUWOK in patients under orthopedic setting <br/ ><br>3 Incidence of adverse events <br/ ><br>4 Overall Global Assessment for Safety <br/ ><br>Timepoint: day 4 and day 28 or EOT
- Secondary Outcome Measures
Name Time Method 1 Clinical Success Rate at EOT <br/ ><br>2 Clinical Responder Rate / Clinical improvement rate at EOT <br/ ><br>3 Clinical Responder Rate / Clinical improvement rate at Early assessment (Day <br/ ><br>4±2) <br/ ><br>4 Microbiological Success Rate <br/ ><br>5 Overall Global Assessment for Efficacy <br/ ><br>Timepoint: day 4 and day 28 or EOT