â??A Multicentric, Open label, Randomized, Comparative, Parallel-group, Active-Controlled Phase III Clinical Trial to Evaluate Safety and Efficacy of Arbekacin Sulphate injection versus Vancomycin injection in Patients diagnosed with MRSA infectionâ??.

Alkem Laboratories Limited0 个研究点目标入组 162 人开始时间: 待定最近更新: 2021年11月24日

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•Patients who are able and are willing to comply with the protocol and have signed IEC/IRB approved Informed Consent Form.
•Both male and female patients from 18 to 65 years of age.
•Patients with negative pregnancy test confirmed by urine dipstick at enrollment.
•Patients with normal Rinne and Weber test.
•Once the patient has been diagnosed with MRSA infection and the same confirmed by a microbiologist in the conditions given below:
•ï?¼Post operative patients.
•ï?¼Systemic infections such as pneumonia (HAP and CAP).
•ï?¼Infections involving deeper soft tissues such as subcutaneous tissue, fascia, skeletal muscles, and bones.
•ï?¼Requiring significant surgical intervention such as infected ulcers, and deep abscess.

•Patients who are unable and are unwilling to sign IEC or IRB approved Informed Consent Form.
•Patient has a history of allergy or serious adverse reaction to aminoglycoside antibiotics.
•Patient is currently participating in another investigational new drug study.
•Patient with medical conditions leading to difficulty in interpreting response such as polymicrobial infection.
•Patient with meningitis / endocarditis.
•Patient with impaired renal function test (Creatinine Clearance < 70 mL/min).
•Patients who test positive for hepatitis B, hepatitis C, HIV or human leucocyte antigen B-27.
•Patients with positive pregnancy test confirmed by urine dipstick, or the intention to become pregnant within the next 30 days.
•Lactating women
•Co-morbid illnesses such as, severe congestive heart failure (CHF) or/and uncontrolled diabetes (HbA1c >8.9%, or fasting plasma glucose [FPG] >250 mg/dL) etc
•Abnormal otoscopic findings, otologic surgery, autoimmune inner ear disease, significant air bone gaps, abnormal tympanograms, history of fluctuant hearing or asymmetry in hearing worse than 25 decibel (dB) at any test frequency and patients of epilepsy.

发起方

Alkem Laboratories Limited