Efficacy and safety of Levonadifloxacin (IV And Oral) in patients of gram positive Bacteremia
Not Applicable
- Conditions
- Health Condition 1: - Health Condition 2: A488- Other specified bacterial diseases
- Registration Number
- CTRI/2020/11/029358
- Lead Sponsor
- Dr Yatin Mehta
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Clinical Response <br/ ><br>2. Microbiological ResponseTimepoint: 1. Day 4, EOT (End of Treatment) and TOC (Test of Cure) <br/ ><br>2. EOT End of Treatment) <br/ ><br>
- Secondary Outcome Measures
Name Time Method Incidence of adverse events <br/ ><br>Incidence of serious adverse events <br/ ><br>Timepoint: Throughout the study