Health Condition 1: - Health Condition 2: A488- Other specified bacterial diseases
Conditions
Interventions
Intervention1: Levonadifloxacin (IV 800 mg & Tablet 500 mg): Levonadifloxacin Intravenous 800 mg twice a day
Levonadifloxacin Tablet 1000 mg twice a day
Total Duration 7-14 days
Control Intervention1
Sponsors
Dr Yatin Mehta
Wockhardt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Adult 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 diagnosed with gram positive Bacteremia and to be treated with Levonadifloxacin (IV or Oral) as per investigatorâ??s discretion.
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, systemic examination or ECG
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Clinical Response 2. Microbiological ResponseTimepoint: 1. Day 4, EOT (End of Treatment) and TOC (Test of Cure) 2. EOT End of Treatment) | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of adverse events Incidence of serious adverse events Timepoint: Throughout the study | — |
Countries
India
Contacts
Public ContactDr Khokan Debnath
Wockhardt Ltd.
Outcome results
None listed