Prescription Event Monitoring Study of Emrok tab. and Emrok IV to evaluate the safety and efficacy in the patients who have bacterial infections.

A prospective Prescription Event Monitoring (PEM) surveillance to study the safety and efficacy of Emrok (Levonadifloxacin injection) and or Emrok O (Levonadifloxacin Tablet). - Nil

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2024/09/073689

Enrollment

30000

Registered

2024-09-10

Start date

Unknown

Completion date

Unknown

Last updated

2024-09-16

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

Conditions

Health Condition 1: A488- Other specified bacterial diseases

Interventions

Intervention1: Emrok IV (Levonadifloxacin IV) Emrok Tab (Levonadifloxacin) Oral.: Emrok (Levonadifloxacin 800mg/100ml) Injection. route of administration: IV will be infused over the period of approx.

Eligibility

Inclusion criteria

Inclusion criteria: 1. Willing to give inform consent. 2. Require Emrok treatment.

Exclusion criteria

Exclusion criteria: Pregnant and lactating women.

Design outcomes

Primary

Measure	Time frame
1. Overall Global Assessment for Safety. 2. Incidence of adverse events. 3.Evaluate the safety profile of EMROK® &/or EMROK O®Timepoint: Visit 1,visit 3 and Visit 8 or or as per PI discretion.	—

Secondary

Measure	Time frame
Clinical Response at early assessmentTimepoint: Day 3±2;Clinical Success RateTimepoint: At EOT/ day 8±2/PI discretion;Microbiological Success RateTimepoint: EOT/ day 8±2 or as per the PI discretion.;Overall Global Assessment for EfficacyTimepoint: EOT/day 8±2 or as per the PI discretion;Usage of EMROK® &/or EMROK O® treatmentTimepoint: EOT/day 8±2 or as per the PI discretion	—

Countries

India

Contacts

Public ContactDr Khokan Debnath

Wockhardt Ltd

purushothamVS@wockhardt.com9739270420

Outcome results

None listed

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