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CTRI Number  CTRI/2013/02/003401 [Registered on: 18/02/2013] Trial Registered Retrospectively
Last Modified On: 29/07/2025
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 Clinical study To evaluate Efficacy and Safety of FDC of Meropenem 1 gm Plus Tazobactam 125mg/250mg injection For the Treatment of Patients with Gram Negative Infection Including Pseudomonas aeruginosa 
Scientific Title of Study   A Phase III, Multicenter, Randomized, Open Label, Clinical study To evaluate Efficacy and Safety of two strengths of Meropenem Plus Tazobactam For the Treatment of Patients with Gram Negative Infection Including Pseudomonas aeruginosa 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
ECTS/12/005 Version no. 02 Dated 03/09/12  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Milan Satia 
Designation  Chief Executive Officer 
Affiliation  Ethicare Clinical Trial Services 
Address  5/C, Vardan Tower, Nr. Vimal House, Vithakbhai Patel Colony,Navrangpura

Ahmadabad
GUJARAT
380014
India 
Phone  09825585119  
Fax    
Email  milansatia@ethicare-cro.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Milan Satia 
Designation  Chief Executive Officer 
Affiliation  Ethicare Clinical Trial Services 
Address  5/C, Vardan Tower, Nr. Vimal House, Vithakbhai Patel Colony,Navrangpura

Ahmadabad
GUJARAT
380014
India 
Phone  09825585119  
Fax    
Email  milansatia@ethicare-cro.com  
 
Details of Contact Person
Public Query  
Name  Mr Shyam Garg 
Designation  Managing Director 
Affiliation  Aqua Vitoe Laboratories 
Address  SCO 398, 1st Floor, Sector 20

Panchkula
HARYANA
134114
India 
Phone  01724648090  
Fax    
Email  aquavitoe@gmail.com  
 
Source of Monetary or Material Support  
Aqua Vitoe Laboratories 
 
Primary Sponsor  
Name  Aqua Vitoe Laboratories 
Address  SCO 398, 1st Floor, Sector 20, Panchkula, Haryana-134114 
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 = 8  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Akhil Mukim  Ahmedabad Institute of Medical Services (AIMS)  Department of Medicine, P N House, Opp. Jethabhai Park, Narayan Nagar Road, Paldi
Ahmadabad
GUJARAT 		 07932523252

drmukim@indiatimes.com 
Dr M K Yadav  CHC Government Hospital  Department of Medicine, Jakhania
Ghazipur
UTTAR PRADESH 		 09412365963

mkyadavskn@gmail.com 
Dr Mahesh Shukla  Dr. Shukla’s Hospital  Ground Floor, Behind Alankar talkies, M.G. Road, Bardoli
Surat
GUJARAT 		 02622220235

drshukla99@yahoo.co.in 
Dr Kartik Patel  Kanoria Hospital and Research Centre  Department of Medicine, Airport- Gandhinagar Highway, Village- Bhat
Gandhinagar
GUJARAT 		 07923969274

drrajendraanand@yahoo.com 
Dr Susheela Shekar  MVJ Medical College & Research Hospital  Dandupalya, 30th KM milestone, National Highway 4, Kolathur P.O., Hoskote
Bangalore
KARNATAKA 		 09886779757

susheela_shekar@yahoo.com 
Dr D Sree Bhushan Raju  Nizam’s Institute of Medical Sciences  Unit II, Department of Nephrology, Punjagutta
Hyderabad
ANDHRA PRADESH 		 04023489000

sreebhushan@hotmail.com 
Dr Tuhina Shukla  Rajaji puram Hospital and Maternity Centre  Department of Gynecology, E-1075, Rajajipuram
Lucknow
UTTAR PRADESH 		 05224011392

dr.tshukla@rediffmail.com 
Dr Balachandra Giriappa  Sapthagiri Institute of Medical Science & Research Centre  15, Chikkasandra, Hesaragatta main Road
Bangalore
KARNATAKA 		 08028393392

sapthagiriclintrac@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 7  
Name of Committee  Approval Status 
Bio-Ethics Forum of Lucknow, Lucknow for Dr Tuhina Shukla  Approved 
MVJ medical college and research hospital Ethics committee, Bangalore for Dr Susheela Shekar  Approved 
Neelkanth Scientific Ethics Committee, Ghazipur for Dr M K Yadav  Approved 
Sapthagiri Institute of Medical Sciences & Research Centre Institutional EC, Bangalore for Dr Balachandra Giriappa  Approved 
Spandan – Independent Ethics Committee, Ahmedabad for Dr Akhil Mukim  Approved 
Spandan – Independent Ethics Committee, Ahmedabad for Dr Kartik Patel  Approved 
Spandan – Independent Ethics Committee, Ahmedabad for Dr Mahesh Shukla  Approved 
 
Regulatory Clearance Status from DCGI
Modification(s)  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  (1) ICD-10 Condition: B962||Escherichia coli [E. coli ] as thecause of diseases classified elsewhere,  
 
Intervention / Comparator Agent
Modification(s)  
Type  Name  Details 
Intervention  Meropenem 1 gm and Tezobactam 125 mg Injection  Thrice daily for 7-14 days by intravenous route 
Intervention  Meropenem 1 gm and Tezobactam 250 mg  Thrice daily for 7-14 days by intravenous route 
Comparator Agent  Meropenem 1 gm injection  Thrice daily for 7-14 days by intravenous route 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1.Written informed consent from the patient.
2.Male or Female patients aged greater than or equals to 18 years.
3.Patient’s culture defining presence of gram negative infection including Pseudomonas aeruginosa.
4.Patients who failed to prior antibacterial treatment can be enrolled but must have a positive culture test.
5.Willingness to comply with the study schedule and procedures.
 
 
ExclusionCriteria 
Details  1.Patients with any condition which in the opinion of the investigator makes the patient unsuitable for inclusion.
2.Baseline pathogens known to be resistant to study agents at the study entry.
3.Concurrent confounding infection.
4.Patients who consume alcohol should not be enrolling into the study.
5.History of anaphylaxis or serious allergy to either study agent or antibiotic agents in the β-lactam class.
6.Patients having low likelihood of either treatment response or survival to follow-up visit.
7.Patients with ALT or AST more than six times the upper limit of normal (ULN).
8.Patients with neutropenia ( 1000 x million neutrophils/L).
9.A history of significant underlying disease or of hypersensitivity to either of the trial drugs.
10.Patient is a female who is pregnant or willing to get pregnant, no ready to use contraceptive measures during the trial period of breast feeding.
11.Hypovolaemia or dehydration from any cause.
12.Participation in any other clinical trial during last 30 days. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Overall Clinical Response   7-14 days 
 
Secondary Outcome  
Outcome  TimePoints 
Changes in culture test for gram negative infection including Pseudomonas aeruginosa, Average Treatment Duration   7-14 days 
 
Target Sample Size   Total Sample Size="300"
Sample Size from India="300" 
Final Enrollment numbers achieved (Total)= "287"
Final Enrollment numbers achieved (India)="287" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   05/11/2012 
Date of Study Completion (India) 02/05/2013 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  		 Not Applicable 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary
Modification(s)  

This will be a multicentric, open-label, randomised, phase III clinical trial involving patients with gram negative infection including Pseudomonas aeruginosa receiving FDC meropenem 1 gm + tazobactam 125mg/250mg  injection (Investigationa product) or meropenem 1 gm injection (comparator product) three times in a day for 7-14 days.

 
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