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

Recruiting

• Conditions: Unspecified bacterial pneumonia,

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

Brief Summary

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

This study aims to evaluate efficacyand safety of Levonadifloxacin (IV And Oral) in patients of Community AcquiredBacterial Pneumonia (CABP).

Duration of treatment will be 5-7 days.(Duration of treatment can be extend upto 14 days in concurrent bacteremia asper investigator’s discretion.)

Primary endpoint - Clinical Response ina subject is defined as: Cure, failure and Indeterminate

Microbiological response is defined as: Cure, failure and Indeterminate

Detailed Description

Not available

Study Timeline

• Study Start: 2020-11-23
• Last Update Posted: 2022-06-29

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: All
• Target Recruitment: 107

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 Community Acquired Bacterial Pneumonia (CABP) 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. Clinical response on Day 4, EOT (End of Treatment) and TOC (Test of Cure) | 2. Microbiological response on EOT (End of Treatment)
2. Microbiological Response	1. Clinical response on Day 4, EOT (End of Treatment) and TOC (Test of Cure) | 2. Microbiological response on EOT (End of Treatment)

Secondary Outcome Measures

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

Trial Locations

Locations (12)

Ashirwad Hospital; 🇮🇳 Thane, MAHARASHTRA, India

Charak Hospital and Research Centre; 🇮🇳 Lucknow, UTTAR PRADESH, India

GMERS Medical College and General Hospital; 🇮🇳 Vadodara, GUJARAT, India

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

Kusum Dhirajlal Hospital; 🇮🇳 Ahmadabad, GUJARAT, India

Lifepoint Multispecialty Hospital; 🇮🇳 Pune, MAHARASHTRA, India

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

Medstar Speciality Hospital; 🇮🇳 Bangalore, KARNATAKA, India

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

R P Chest Hospital; 🇮🇳 Bangalore, KARNATAKA, India

Scroll for more (2 remaining)

Ashirwad Hospital

🇮🇳Thane, MAHARASHTRA, India

Dr Shirkant Deshpande

Principal investigator

9822017445

writetoshrikant@rediffmail.com