A clinical trial to study the effects of two drugs, Linezolid 1200mg SR Tablet OD and Linezolid 600mg Tablet BD in subjects suffering with Uncomplicated Skin and Soft Tissue Infections

Phase 3

Completed

• Conditions: Health Condition 1: null- Uncomplicated Skin and Soft tissue infections

• Registration Number: CTRI/2013/07/003848
• Lead Sponsor: Inventia Healthcare Pvt Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 240

Inclusion Criteria

1)Subjects who are able and are willing to comply with the protocol and have signed IEC/IRB approved Informed Consent Forms (ICF) voluntarily

2)Subjects of either sex having age between 18 years to 65 years with clinical signs and symptoms of Uncomplicated Skin and Soft Tissue Infections with onset of symptoms more than or equal to 72 hrs prior to screening period

3)Have a degree of understanding such that the patient can communicate intelligibly with the investigator and study coordinator

4)Are judged to be reliable to keep all appointments and able to swallow all required medication without opening or crushing

5)Female subjects of childbearing potential require a Negative Urine Pregnancy Test and must agree to abstinence or to use prescription contraceptives and to use a barrier contraceptive device along with a spermicidal product during the study period.Subject who are surgically sterile, menopausal or using contraceptive implants prior to the study to the study enrollment are not required to utilize dual contraceptive techniques

Exclusion Criteria

1)Subjects unwilling to sign ICF

2)Subjects with complicated skin and soft tissue infections

3)Subjects known to have or history of severe neutropenia ( <500 cells/mm3), HIV, any malignant disease, Tuberculosis, Uncontrolled hypertension, Pheochromocytoma and Thyrotoxicosis

4)Any other condition(s) which would confound or interfere with evaluation or prevent compliance with the study protocol

5)Subjects having known allergy against Linezolid and other drug ingredients

5)Subjects taking any of the following types of medications: directly and indirectly acting sympathomimetic agents (e.g. pseudoephedrine), vasopressive agents (e.g. epinephrine, norepinephrine), dopaminergic agents (e.g. dopamine, dobutamine)

6)Subjects having a history of alcohol or drug abuse

Study & Design

• Study Type: Interventional
• Study Design: Not specified