A Prospective Prescription Event Monitoring PEM surveillance of EMROK Levonadifloxacin injection and or EMROK O Levonadifloxacin tablet.

This is a prospective and multi-centric prescription event monitoring (PEM) surveillance in patients who have been prescribed with either EMROK® or EMROK-O® or both. Eligible patients will be identified by the investigator / physician based on selection criteria. All the patients must have received EMROK® or EMROK–O® in routine clinical practice at the study site. Data would be collected from the medical records of such patients prospectively. After identification of patients for this PEM, prescribing investigator would record patient’s demographics, physical examination, Medical history and Concomitant medication, Prescribing indication and regimen for EMROK® or EMROK–O®, adverse events associated with use of EMROK® or EMROK-O® in case record form. .

Safety assessment would be done on the basis of adverse event encountered by the patients during the usage of EMROK® and / or EMROK - O®. Efficacy would be determined by the investigator in terms of success, cure, improvement or failure with respect to changes in the symptoms of infection pre and post EMROK therapy changes

Investigator will perform global assessment for efficacy and safety of EMROK® and / or EMROK – O® at the end of study period on 5 point scale. The investigator shall provide the declaration for accuracy of the data. The observation period would be the earliest of any of following event viz. End of therapy / Lost to follow-up / Clinical success / Clinical failure. The relevant data would be updated in the case record form.

Day 1 of Treatment initiation

Patients who have been prescribed with EMROK® or EMROK – O® by their treating physicians will be identified for the study. Written informed consent will be obtained from eligible patients to share information and medical records during observation period of surveillance. Demographics, physical examination, medical history, concomitant medication, clinical assessment of signs and symptoms, microbiological assessment including culture report, prescribing pattern including but not limited to indication, dose, frequency, duration of EMROK® or EMROK – O® will be recorded in case report form.

Follow up 1 for data collection; Early Assessment (Day 3 ± 2 of treatment initiation) Patient will be followed up for early assessment of EMROK treatment initiation. Finding of clinical assessment, microbiological assessment, culture report, concomitant medications, adverse event, if any will be recorded in case report form.

Follow up 2 for data collection; End of Therapy (EOT) (Day 7±2 Onwards until 15 days of treatment initiation or EOT)

Patient will be followed up at end of therapy. Finding of clinical assessment, concomitant medications, adverse event, if any and microbiological assessment as per availability will be recorded in case report form. Investigator will assess overall effectiveness and safety based on 5 point scale (Excellent, Very good, Good, Satisfactory and Poor).