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

A Prospective, Open label, Single arm, Multi-centric, Investigator initiated study (IIS) for evaluation of efficacy and safety of Levonadifloxacin (IV And Oral) in patients of Community Acquired Bacterial Pneumonia (CABP).

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/11/029258
Enrollment
107
Registered
2020-11-20
Start date
Unknown
Completion date
Unknown
Last updated
2022-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: J159- Unspecified bacterial pneumonia

Interventions

Intervention1: Levonadifloxacin (IV 800 mg and Tablet 500 mg): Levonadifloxacin IV 800 mg twice a day Levonadifloxacin tablet 1000 mg twice a day Total duration 5-14 days Control Intervention1: Nil: N

Sponsors

Dr B P Singh
Lead Sponsor
Wockhardt Ltd
Collaborator

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 Community Acquired Bacterial Pneumonia (CABP) and to be treated with Levonadifloxacin (IV or Oral) as per investigatorââ?¬•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

MeasureTime frame
1. Clinical Response 2. Microbiological ResponseTimepoint: 1. Clinical response on Day 4, EOT (End of Treatment) and TOC (Test of Cure) 2. Microbiological response on EOT (End of Treatment)—

Secondary

MeasureTime frame
Incidence of adverse events Incidence of serious adverse events Timepoint: baseline, Visit 2, Visit 3 and Visit 4—

Countries

India

Contacts

Public ContactDr Khokan Debnath

Wockhardt Ltd

jadhal@wockhardt.com9930696711

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026