Health Condition 1: null- Uncomplicated Skin and Soft tissue infections
Conditions
Interventions
Intervention1: Linezolid 1200mg SR Tablet OD: Dose: Linezolid 1200 mg SR Tablet
Frequency: On daily basis for 10 continuous days
Duration: For 10 days
Route of administration: Oral
Control Interventio
Sponsors
Inventia Healthcare Pvt Ltd
Eligibility
Inclusion criteria
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
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 ( 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical cure & Microbiological (eradication of pathogen) cure as judged by investigator at the end of protocol therapy Timepoint: Time frame: Visit 3 (Day 10) after the administration of study drug | — |
Secondary
| Measure | Time frame |
|---|---|
| Assessment of the nature, incidence, and duration of adverse events monitored throughout, during and at the completion of treatment by clinical assessments periodically & review of all discontinuations due to adverse events during and at the completion of the trial to assess the safety and tolerability of the compound Assessment of overall tolerability graded by the investigator and subjects at the end of protocol therapy i.e. Day 10 Timepoint: Time frame: Visit 1 (Day 0), Visit 2 (Day 1) & Visit 3 (Day 10) Time frame: Visit 3 (Day 10) | — |
Countries
India
Contacts
Public ContactDr Amit Bhatt
Nexus Clinical Research (India) Ltd.
Outcome results
None listed