A multicentric phase-III randomized clinical trial to be conducted in Methicillin Resistant Staphylococcus aureus(MRSA) infection to evaluate the efficacy and safety of Arbekacin 200mg once daily (interventional drug) against Vancomycin 1000mg twice daily (comparator drug)

Phase 3

Completed

• Conditions: Sepsis due to Streptococcus pneumoniae,

• Registration Number: CTRI/2014/10/005088
• Lead Sponsor: Alkem Laboratories Limited

Brief Summary

**In this study  a total of 162 patients will be enrolled from Indian Population.  The study will be conducted in multiple centers [multicentric] employing Open label, randomized, parallel group, and prospective study design. The vancomycin hydrochloride is clinically proven and the drug of choice for the indication of MRSA infection, which we will be using as “1000 mg injection†as the control treatment in this trial.**

Detailed Description

Not available

Study Timeline

• Study Start: 2014-10-13
• Study Completion: 2017-12-07
• Last Update Posted: 2019-11-13

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 162

Inclusion Criteria

• •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: Post operative patients.
• Systemic infections such as pneumonia (HAP and CAP).
• Infections involving deeper soft tissues such as subcutaneous tissue, fascia, skeletal muscles, and bones.
• Requiring significant surgical intervention such as infected ulcers, and deep abscess.

Exclusion Criteria

• •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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate the safety and efficacy of the drug Arbekacin Sulphate in patient diagnosed with MRSA infection including septicemia and pneumonia where Vancomycin Hydrochloride is indicated.	The primary efficacy variables will be clinical outcomes in terms of | 1) Clinical cure rate of infection at 3rd day of treatment,EOT/discontinuation & followup visit i.e. 7 (±2) days after EOT. | 2) Microbiological cure rate of applicable culture(s) in evaluable patients at follow-up visit i.e. on 3 day after EOT.

Secondary Outcome Measures

Name	Time	Method
To assess the safety and tolerability of Investigational drugs including laboratory investigations	Day of screening, Day 3, day 7, end of treatment (EOT) & on follow up 7 (±2) days after EOT follow-up visit i.e. on 3rd day after EOT.

Trial Locations

Locations (25)

GMERS Medical College and Hospital Sola, Ahemdabad; 🇮🇳 Ahmadabad, GUJARAT, India

AIIMS Bhubaneswar; 🇮🇳 Baleshwar, ORISSA, India

Apollo Hospital, Hyderabad, Andhra Pradesh; 🇮🇳 Hyderabad, ANDHRA PRADESH, India

Deenanath Mangeshkar Hospital Pune; 🇮🇳 Pune, MAHARASHTRA, India

Down Town Hospital Limited; 🇮🇳 Dibrugarh, ASSAM, India

Hi Tech Medical College and Hospital Bhubaneswar Odisha (INDIA); 🇮🇳 Balangir, ORISSA, India

Inamdar Multispeciality Hospital; 🇮🇳 Pune, MAHARASHTRA, India

Institute of Medical science and SUM Hospital; 🇮🇳 Baleshwar, ORISSA, India

K R Hospital Mysore Medical College; 🇮🇳 Mysore, KARNATAKA, India

Kasturba Medical College and Hospital; 🇮🇳 Udupi, KARNATAKA, India

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GMERS Medical College and Hospital Sola, Ahemdabad

🇮🇳Ahmadabad, GUJARAT, India

Dr Krina Bharat Patel

Principal investigator

9227222221

y2k_kbpatel@yahoo.com