Study in patients with Bone and Joint Infectio
- Conditions
- Health Condition 1: M898- Other specified disorders of bone
- Registration Number
- CTRI/2020/12/029718
- Lead Sponsor
- Dr Vasant Nagvekar
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Efficacy EndpointTimepoint: Primary end point: Clinical Response on Day 4, 8, 14, 28 End of Treatment (EOT) and Test of Cure (TOC) <br/ ><br>Secondary end point: Microbiological response on End of Treatment (EOT) <br/ ><br>
- Secondary Outcome Measures
Name Time Method 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.