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CTRI Number  CTRI/2014/10/005088 [Registered on: 10/10/2014] Trial Registered Prospectively
Last Modified On: 13/11/2019
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   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) 
Scientific Title of Study   “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 infection”. 
Trial Acronym   
Secondary IDs if Any
Modification(s)  
Secondary ID  Identifier 
Alkem/CT/Arbk/032012, version 04 dated 07.08.2014  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)  
Name  Dr Ambrish Srivastava 
Designation  Assistant Vice President Clinical Research and Medical Affairs 
Affiliation  Alkem Laboratories Limited 
Address  Alkem Laboratories Limited Alkem House Devashish Adjacent to Matulya Centre Senapati Bapat Marg Lower Parel Mumbai Pin Code 400013 Maharashtra INDIA
Alkem Laboratories Limited Alkem House Devashish Adjacent to Matulya Centre Senapati Bapat Marg Lower Parel Mumbai Pin Code 400013 Maharashtra INDIA
Mumbai
MAHARASHTRA
400013
India 
Phone  022-39829572  
Fax  022-24903831  
Email  ambrish.srivastava@alkem.com  
 
Details of Contact Person
Scientific Query
Modification(s)  
Name  Dr Ambrish Srivastava 
Designation  Assistant Vice President Clinical Research and Medical Affairs 
Affiliation  Alkem Laboratories Limited 
Address  Alkem Laboratories Limited Alkem House Devashish Adjacent to Matulya Centre Senapati Bapat Marg Lower Parel Mumbai Pin Code 400013 Maharashtra INDIA
Alkem Laboratories Limited Alkem House Devashish Adjacent to Matulya Centre Senapati Bapat Marg Lower Parel Mumbai Pin Code 400013 Maharashtra INDIA
Mumbai
MAHARASHTRA
201306
India 
Phone  022-39829572  
Fax  022-24903831  
Email  ambrish.srivastava@alkem.com  
 
Details of Contact Person
Public Query
Modification(s)  
Name  Mukesh Kumar 
Designation  Director- Clinical Operation 
Affiliation  KPS Clinical Services Pvt Ltd 
Address  KPS Clinical Services Pvt Ltd S203-204 2nd Floor Meridian View Plaza Alpha Commercial Belt Sec. Alpha 1 Greater Noida
KPS Clinical Services Pvt Ltd S203-204 2nd Floor Meridian View Plaza Alpha Commercial Belt Sec. Alpha 1 Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH
201306
India 
Phone  01204213840  
Fax  01204213840  
Email  mukesh@kpsclin.com  
 
Source of Monetary or Material Support  
Alkem Laboratories Limited 
 
Primary Sponsor  
Name  Alkem Laboratories Limited 
Address  Alkem House Devashish S. B. Road Lower Parel (W) Mumbai - 400013; India 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 25  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Krina Bharat Patel  GMERS Medical College and Hospital Sola, Ahemdabad   Department of Dermatology GMERS (Gujarat Medical Education and Research Society) Medical College and Hospital Sola , S.G Highway Ahemdabad Pin Code: 380061 Gujarat (INDIA)
Ahmadabad
GUJARAT 		 9227222221

y2k_kbpatel@yahoo.com 
Dr Tushar Subhadarshan Mishra  AIIMS Bhubaneswar  Dr. Tushar Subhadarshan Mishra Associate Professor Department of General Surgery All India Institute of Medical Sciences (AIIMS ) Sijua, Patrapada, Bhubaneswar, Pincode 751019 Odhisha INDIA
Baleshwar
ORISSA 		 9438884251

doctushar@gmail.com 
Dr Lavanya Nutankalva  Apollo Hospital, Hyderabad, Andhra Pradesh  Department of Infectious Disease Apollo Hospitals, Jubilee Hills Hyderabad, Pin Code: 500096 Andhra Pradesh (INDIA)
Hyderabad
ANDHRA PRADESH 		 09704489991
040-23543270
lavinutanka@yahoo.com 
Dr Utrakrant Kurlekar   Deenanath Mangeshkar Hospital Pune  Dr. Utrakrant Kurlekar Head Department of Surgery Deenanath Mangeshkar Hospital Off Kane Road Near Mhatre Bridge Erandawne Pune 411004 Maharashtra INDIA
Pune
MAHARASHTRA 		 9822025051

ukurlekar@gmail.com 
Dr Manabendra Nayak  Down Town Hospital Limited  Dr. Manabendra Nayak Department of Medicine Down Town Hospital Limited G.S Road, Dispur, Guwahati Pin Code 781006 Assam INDIA
Dibrugarh
ASSAM 		 0361-2331003
0361-2330678
dr.mnayak@yahoo.co.in 
Dr Sarat Kumar Behera  Hi Tech Medical College and Hospital Bhubaneswar Odisha (INDIA)  Hi Tech Medical College and Hospital Health Park, Pandara, Rasulgarh Bhubaneswar Pin Code 751025 Odisha (INDIA)
Balangir
ORISSA 		 9438554039

drsarat2010@rediffmail.com 
Dr Sameer Badami  Inamdar Multispeciality Hospital  Consultant Surgeon, Department of General Surgery, Inamdar Multispeciality Hospital, S/N. 15, Fatimanagar, Wanworie, Pin: 411040
Pune
MAHARASHTRA 		 09325409625

drsameerbadami@gmail.com 
Dr Chandan Das  Institute of Medical science and SUM Hospital  Institute of Medical Science and Sum Hospital K8 Kalinga Nagar Ghatika Bhubaneshwar Pin 751003 Odisa
Baleshwar
ORISSA 		 9937063390
0674-236223
drchandan_das1204@rediffmail.com 
Dr Madhu B S  K R Hospital Mysore Medical College   Department of General Surgery K R Hospital Mysore Medical college and Research Institute Irwin Road Mysore Pin code 570001 Karnatka India
Mysore
KARNATAKA 		 9900513688

drmadhubs@gmail.com 
Dr Muralidhar Verma  Kasturba Medical College and Hospital  Department of Medicine Manipal University PO Box No. 7 Manipal Pin Code 576104 Karnataka INDIA
Udupi
KARNATAKA 		 09845069639
0820-2571934
drmuralidharvarma@yahoo.co.in 
Dr Padhye Devdatta Damodar  Lifepoint Multispeciality Hospital,Pune  145/1, Mumbai Bangalore Highway,Near Hotel Sayaji,Pune Pin code: 411057
Pune
MAHARASHTRA 		 91-2066434343
91-2066434399
padhye.dev@gmail.com 
Dr Rajeev Agarwal  M.V. Hospital and Research Center  Department of Dermatology M. V Hospital & Research Centre 314/30 Mirza Mandi Chowk Lucknow Pin Code 226003, Uttar Pradesh (INDIA)
Lucknow
UTTAR PRADESH 		 05222258215
0522-4016051
mvhrclko@gmail.com 
Dr Vindod Kumar  Maulana Azad Medical College (MAMC) Delhi   Department of Orthopaedics, Maulana Azad Medical College, Lok Nayak and Associated Hospitals, Bahadur Shah Zafar Marg New Delhi Pin Code: 110002 (INDIA)
New Delhi
DELHI 		 91-9968604321

drkumarvinod@rediffmail.com 
Dr Harish Mathur  Mavens Hospitals Ajmer  Department of Orthopedics Mavens Hospitals N-37 Lane near Reliance Fresh, Sagar Vihar Colony Vaishali Nagar Ajmer Pin Code-305001 Rajasthan (INDIA)
Ajmer
RAJASTHAN 		 0145-2642799
0145-2642799
drharishmathur@yahoo.com 
Dr Pradeep Sharma  Noble Hospital  Consultant Surgeon, Department of General Surgery, Nobel Hospital, 153, Magarpatta City Road, Hadapsar Pin: 411013 (India)
Pune
MAHARASHTRA 		 09371016344

drpradeepsharma@gmail.com 
Dr Pankaj Srivastava  Om Surgical Center and Maternity Home  Om Surgical Center and Maternity Home, Shri Krishna Nagar, Varansi
Varanasi
UTTAR PRADESH 		 05422586191

omresearchcenter@gmail.com 
Dr Indraneel Basu  Popular Hospital Varanasi  Popular Hospital, N-10/60, A-2 DLW Road Kakarmatta Varanasi Pin Code 221009 Uttar Pradesh INDIA
Varanasi
UTTAR PRADESH 		 9935036063
0542-2300506
popularcrvns@gmail.com 
Dr VV Satyanarayana  Rajiv Gandhi Institute Of Medical Sciences   Rajiv Gandhi Institute of Medical Sciences and (RIMS) Government General Hospital, Srikakulam Pin Code -532001 Andhra Pradesh (INDIA)
Srikakulam
ANDHRA PRADESH 		 9963744345

rimsresearch@gmail.com 
Dr Veerendraswamy S M  S S Institute of Medical Science and Research Center  Dr. Veerendraswamy S M Professor Department of Surgery S S Institute of Medical Science and Research Center, Jnanshankara, NH-4 Bypass Road, Post Box No: 1, Davangere, Karnataka, INDIA
Davanagere
KARNATAKA 		 9845236274

smveerndra@hotmail.com 
Dr R P Agrawal  Sardar Patel Medical College & AGH Hospital Bikaner  Dr. R. P Agrawal Professor and HOD (Medicine) Diabetes Care and Research Center, Sardar Patel Medical College & AGH Hospital, Bikaner Pin Code 334001 Rajasthan (INDIA)
Bikaner
RAJASTHAN 		 9414142931
0151-220231
drrpagrawal@yahoo.co.in 
Dr Atul Kakar  Sir Ganga Ram Hospital  Department of Medicine Sir Ganga Ram Hospital Rajinder Nagar New Delhi Pin 110060
New Delhi
DELHI 		 9811110802
011-42437230
atulkakar@hotmail.com 
Dr Nilay N Suthar  Smt NHL Municipal Medical College Seth V.S General Hospital, Ellisebridge Ahmedabad  Department of Medicine Smt NHL Municipal Medical College Seth V.S General Hospital, Ellisebridge Ahmedabad (NHLIEC) Pin Code-380006 Gujarat (INDIA)
Ahmadabad
GUJARAT 		 9825295840

nilaysuthar@gmail.com 
Dr Abhay S Dube  Subharti Medical College and Hospital  Professor and Head Department of Orthopedic Surgery Subharti Medical College and Hospital Subhartipuram NH-58, Meerut By pass (Delhi-Haridwar Road Pin Code 250005 Uttar Pradesh INDIA
Meerut
UTTAR PRADESH 		 01212766556
0121-2439112
abhaysdube@yahoo.com 
Dr Ashish Kumar Deb  Sudbhawana Hospital Varanasi  Department of Medicine Sudbhawana Hospital B-31/80, 23-B Bhogabir Lanka, Varanasi Pin Code 221005 Uttar Pradesh
Varanasi
UTTAR PRADESH 		 9839058553
0542-236778
sudbhawanacrvns@gmail.com 
Dr Ram Murti Singh  Trimurti Hospital  Trimurti Hospital Gilat Bazar Bhojuveer Varansi Pin 221002 Uttar Pradesh
Varanasi
UTTAR PRADESH 		 9415221720
0542-2284999
ram.murti@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 22  
Name of Committee  Approval Status 
AIIMS Institutional Ethics Committee  Not Applicable 
Deenananth Mangeshkar Hospital Institutional Ethics Commitee   Approved 
Down Town Institutional Ethics Committee  Approved 
Ethics Committee Apollo Hospital Hyderabad  Approved 
Ethics Committee, Inamdar Multispeciality Hospital  Not Applicable 
IEC Subharti Medical College and Hospital  Approved 
Institutional Ethics Committee, GMERS Sola Ahemdabad  Submittted/Under Review 
Institutional Ethics Committee, Hi Tech Medical College and Hospital  Approved 
Institutional Ethics Committee, MAMC Delhi  Approved 
Institutional Ethics Committee, Manipal University  Approved 
Institutional Ethics Committee, MV Hospital Lucknow  Approved 
Institutional Ethics Committee, Noble Hospital Pvt. Ltd.  Not Applicable 
Institutional Ethics Committee, Smt NHL Municipal Medical College, Ahmedabad   Submittted/Under Review 
Lifepoint Research Ethics Committee  Approved 
Mavens Institutional Ethics Committee, Ajmer  Approved 
Om Surgical Center  Approved 
Popular Hospital Ethics Commitee, Varanasi  Approved 
RIMS Institutional Ethics Commitee  Submittted/Under Review 
Sardar Patel Medical College AGH Hospital Bikaner  Approved 
SSIMS Instiutional Ethics Committee  Approved 
Sudhbhawana Hospital Ethics Commitee, Varanasi  Approved 
Trimurti Hospital Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI
Modification(s)  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  MRSA Infection, (1) ICD-10 Condition: A403||Sepsis due to Streptococcus pneumoniae,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Arbekacin Sulphate   Arbekacin Sulphate 200 mg will be administered intravenously once daily by slow bolus (5min.) The minimum treatment duration for the study subject will be 7days may extend upto maximum 14 days depending upon investigator discretion.  
Comparator Agent  Vancomycin  Vancomycin Hydrochloride 1000 mg (BD) (500mg x 2 vials) will be administered intravenously twice daily by slow infusion (60 min.)It should be administered at a rate not more than 10mg/min or over a period of at least 60 min whichever is longer. The minimum treatment duration for the study subject will be 7days may extend upto maximum 14 days depending upon investigator discretion. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  •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.
 
 
ExclusionCriteria 
Details  •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.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome
Modification(s)  
Outcome  TimePoints 
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
Modification(s)  
Outcome  TimePoints 
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. 
 
Target Sample Size   Total Sample Size="162"
Sample Size from India="162" 
Final Enrollment numbers achieved (Total)= "162"
Final Enrollment numbers achieved (India)="162" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   13/10/2014 
Date of Study Completion (India) 12/07/2017 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="3"
Days="15" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

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. 

 
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