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Prescription Event Monitoring (PEM) for EMROK tablet and Injections

Prospective, Prescription Event Monitoring (PEM) surveillance of EMROK® (Levonadifloxacin injection) &/or EMROK â?? O® (Levonadifloxacin tablet)

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2021/08/035789
Enrollment
1500
Registered
2021-08-18
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

None listed

Sponsors

Wockhardt Ltd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Adult patients of any gender who have been prescribed with EMROK® or EMROK â?? O® by their treating physicians can be part of this prescription event monitoring surveillance

Exclusion criteria

Exclusion criteria: 1. Known to be hypersensitive to Levonadifloxacin and any other quinolone antibactrial or to any other excepients 2. Patients having history of Tendon disorders

Design outcomes

Primary

MeasureTime frame
To evaluate safety and efficacy of EMROK® (Levonadifloxacin injection) &/or EMROK â?? O® (Levonadifloxacin tablet) in real world settingTimepoint: Day 1, Day 3 and Day 8—

Secondary

MeasureTime frame
Clinical Success rate Microbiological Success rate Overall Global Assessment for Efficacy Overall Global Assessment for Safety Usage of EMROK Treatment Incidence of Adverse events Timepoint: Day 1 Day 3 and Day 8—

Countries

India

Contacts

Public ContactDr Khokan Debnath

Wockhardt Ltd.

kapilm@wockhardt.com022-26596742

Outcome results

None listed

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