Health Condition 1: M898- Other specified disorders of bone
Conditions
Interventions
Intervention1: Levonadifloxacin: Levonadifloxacin (IV and Oral)
Levonadifloxacin IV 800 mg (each vial contains Levonadifloxacin 100 ml containing 8mg/ml) And Levonadifloxacin tablets (each tablet cont
Sponsors
Dr Vasant Nagvekar
Eligibility
Inclusion criteria
Inclusion criteria: Male or female subjects with 18 years and above of age 2. Subjects must be willing to participate in the study and provide a written informed consent 3. Patient with gram positive bacteria - Bone and Joint Infection (Osteomyelitis, Septic arthritis, Prosthetic/Implant infection, Diabetic foot infection with osteomyelitis, Discitis /spinal osteomyelitis etc) except mycobacterial infection to be treated with Levonadifloxacin (IV or Oral) as per Investigatorâ??s judgement
Exclusion criteria
Exclusion criteria: 1. Subjects with history of hypersensitivity to any of the study drugs or same class of drugs 2. Subjects who received any experimental drug within 30 days prior to enrolment 3. Subjects who, in the judgment of the Investigator, are likely to be noncompliant or uncooperative during the study 4. Subjects with any abnormality that the Investigator deems to be clinically relevant, either on medical history, physical examination or ECG
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy EndpointTimepoint: Primary end point: Clinical Response on Day 4, 8, 14, 28 End of Treatment (EOT) and Test of Cure (TOC) Secondary end point: Microbiological response on End of Treatment (EOT) | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety - Tolerability EndpointTimepoint: Safety evaluation will be based on Adverse Events (AEs) reported, vital signs and physical examination findings, clinical laboratory evaluation, and ECG collected during the study. | — |
Countries
India
Contacts
Public ContactDr Khokan Debnath
Wockhardt Limited
Outcome results
None listed