Efficacy and safety of Levonadifloxacin (IV And Oral) in patients of gram positive Bacteremia

Recruiting

• Conditions: Other specified bacterial diseases,

• Registration Number: CTRI/2020/11/029358
• Lead Sponsor: Dr Yatin Mehta

Brief Summary

This is Prospective, Open label, Single arm, Multi-centric, Investigator initiated study.

This study aims to evaluate efficacy and safety of Levonadifloxacin (IV And Oral) in patients of gram positive Bacteremia.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-11-26
• Last Update Posted: 2023-01-20

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: All
• Target Recruitment: 76

Inclusion Criteria

• 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 investigator’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	1. Day 4, EOT (End of Treatment) and TOC (Test of Cure) | 2. EOT End of Treatment)
2. Microbiological Response	1. Day 4, EOT (End of Treatment) and TOC (Test of Cure) | 2. EOT End of Treatment)

Secondary Outcome Measures

Name	Time	Method
Incidence of adverse events	Incidence of serious adverse events

Trial Locations

Locations (11)

Hansa Clinic and Hospital; 🇮🇳 DAMAN, & DIU, India

Lifepoint Multispecialty Hospital; 🇮🇳 Pune, MAHARASHTRA, India

Mahatma Gandhi Medical College and Research Institute; 🇮🇳 Pondicherry, PONDICHERRY, India

Medanta, The Medicity; 🇮🇳 Gurgaon, HARYANA, India

Medstar Speciality Hospital; 🇮🇳 Bangalore, KARNATAKA, India

Midland Healthcare & Research Center; 🇮🇳 Lucknow, UTTAR PRADESH, India

Pushpanjali Hospital & Research Center Pvt. Ltd.; 🇮🇳 Agra, UTTAR PRADESH, India

Ruby Hall Clinic; 🇮🇳 Pune, MAHARASHTRA, India

Sarvodaya Hospital and Research Centre; 🇮🇳 Faridabad, HARYANA, India

Shree Ashirwad Hospital; 🇮🇳 (Suburban), MAHARASHTRA, India

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Hansa Clinic and Hospital

🇮🇳DAMAN, & DIU, India

Dr Brijal Patel

Principal investigator

9909012179

hansahospital@gmail.com