Efficacy and safety of Levonadifloxacin (IV And Oral) in patients of Community Acquired Bacterial Pneumonia (CABP).

Not Applicable

• Conditions: Health Condition 1: J159- Unspecified bacterial pneumonia

• Registration Number: CTRI/2020/11/029258
• Lead Sponsor: Dr B P Singh

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 17 October 2022

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 Community Acquired Bacterial Pneumonia (CABP) and to be treated with Levonadifloxacin (IV or Oral) as per investigatorââ?¬•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. Clinical response on Day 4, EOT (End of Treatment) and TOC (Test of Cure) <br/ ><br>2. Microbiological response on EOT (End of Treatment)

Secondary Outcome Measures

Name	Time	Method
Incidence of adverse events <br/ ><br>Incidence of serious adverse events <br/ ><br>Timepoint: baseline, Visit 2, Visit 3 and Visit 4