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CTRI Number  CTRI/2017/11/010369 [Registered on: 03/11/2017] Trial Registered Retrospectively
Last Modified On: 19/05/2020
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 the Efficacy and Safety of drug IZIPENEM (Meropenem 1000 mg/ml injection) in patients with Bacterial infections. 
Scientific Title of Study   A Prospective, Interventional, Randomised, Double Blind, Parallel Group, Comparative Clinical study to evaluate the Efficacy and Safety of drug IZIPENEM (Meropenem 1000 mg/ml injection) and reference drug Meronem IV in patients with Bacterial infections. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
ICBio/CR/BPPL/0321/67, Version 01 Dated 21 Mar 2016   Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr N Vijaya Kumar 
Designation  General Physician,M.B.B.S, M.D 
Affiliation  Sri Venkateshwara Hospital 
Address  #86, Hosur main road, Madiwala

Bangalore
KARNATAKA
560068
India 
Phone  9448116114  
Fax    
Email  kumardrvijay5@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Harisha S 
Designation  Director Operations 
Affiliation  ICBio Clinical Research Pvt. Ltd. 
Address  #16 & 18 ICBio Tower, Yelahanka Main Road Chikkabettahalli, Vidyaranyapura,

Bangalore
KARNATAKA
560097
India 
Phone  9900111997  
Fax  08023641033  
Email  harish@icbiocro.com  
 
Details of Contact Person
Public Query
 
Name  Dr Harisha S 
Designation  Director Operations 
Affiliation  ICBio Clinical Research Pvt. Ltd. 
Address  #16 & 18 ICBio Tower, Yelahanka Main Road Chikkabettahalli, Vidyaranyapura,

Bangalore
KARNATAKA
560097
India 
Phone  9900111997  
Fax  08023641033  
Email  harish@icbiocro.com  
 
Source of Monetary or Material Support  
BKRS PHARMA PVT. LTD. office 421,Floor 4th tower B, Spazedge commercial complex sector 47, sohna road, Gurgaon -122002 (Haryana), India  
 
Primary Sponsor  
Name  BKRS PHARMA PVT LTD 
Address  Office 421, 4th Floor, Tower-B, Spazedge Commercial Complex Sector-47, Sohna Road, Gurgaon-122002 (Haryana) India  
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr N Vijaya Kumar  Sri Venkateshwara Hospital  #86, Hosur main road, Madiwala
Bangalore
KARNATAKA 
9448116114

kumardrvijay5@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SRI VENKATESHWARA HOSPITAL ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Notified 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  , Bacterial Infections: Respiratory tract infections, Urinary tract infections , gynaecological Infections and Bacterial meningitis ,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  group 1 Meropenem 1000mg/ml injection for 04 days   group 1 Intervention (Meropenem 1000mg/ml) injection, 500 mg IV every 8 hours in the treatment of pneumonia, UTI and gynaecological infections 1 grams IV every 8 hours in the treatment of hospital acquired pneumonias, peritonitis, presumed infections in febrile neutropenic patients, In meningitis the recommended dosage is 2 grams every 8 hours. Duration of dose 04 days  
Comparator Agent  Group 2 Meronem IV 1000 mg/ml injection for 04 days   Group 2 Comparator (Meronem IV 1000 mg/ml) injection, 500 mg IV every 8 hours in the treatment of pneumonia, UTI and gynaecological infections 1 gram IV every 8 hours in the treatment of hospital acquired pneumonia, peritonitis, presumed infections in febrile neutropenic patients, In meningitis the recommended dosage is 2 grams every 8 hours. Total Duration of dose is 04 days  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Male and female above 18 years with respiratory tract infection,urinary tract infection ,gynaecological infections, bacterial Meningitis ( any one of the disease).
Patients should have clinical findings that support a diagnosis of HABP/VABP/HCAP Within 48 hours before starting empiric therapy a subject chest radiograph should show the presence of a New or progressive infiltrate, cavitation, or effusion suggestive of pneumonia
Patients with VABP should have a clinical pulmonary infection score greater than or equal to 5
Lower Urinary tract infection symptoms(dysuria, urgency, frequency, suprapubic pain) 
 
ExclusionCriteria 
Details  Metastatic hepatic disease
Malignant ascites
CNS disease, including metastatic CNS disease
Cirrhosis, Adult respiratory distress syndrome
Marked hepatic disease (bilirubin level, more than twice the upper limit of normal [ULN] or alanine aminotransferase level, more than four times the ULN)
Known or suspected significant renal impairment (serum creatinine level, greater than 1.5 mg/dL)
Neurosurgery within 1 month of entry into the trial
Conditions treated with anticonvulsant medications
Active colitis
Exposure to other investigational drugs within days of trial entry
Neutropenia
History of Cystic fibrosis, polycystic Kidney Disease, cervical cancer, Poly microbial bacteremia. Auto-immune disease, lymphoma or leukemia
Subjects with pneumonia caused by pathogens resistant to
Meropenem (MIC greater than or equal to 16µg/ml) or a prior meropenem therapy failure.
In case of renal abscess, lack of early drainage
Haematogenous infection or other concomitant infection
Renal transplant recipients
Partial or complete cervical excision
Auto-immune disease
Bacterial Vaginosis or Candidiasis (current or past 3 months)
History of allergies to Beta-lactam antimicrobials
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Changes in Clinical Evaluation of bacterial infections   screening to End of Treatment ( Day-4 
 
Secondary Outcome  
Outcome  TimePoints 
Changes in the microbial response levels
Incidence and rate of adverse events
 
Screening to End of Treatment ( Day 4)  
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   27/06/2016 
Date of Study Completion (India) 05/08/2016 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="0"
Days="14" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary
Modification(s)  
 A Prospective ,Interventional, Randomised, Double Blind ,Parallel Group Comparative clinical study to evaluate the efficacy and safety of drug IZIPENEM (Meropenem 1000 mg/ml injection) and reference drug Meronem IV in patients with bacterial infections

Purpose of the study : To compare the safety and Efficacy of drug IZIPENEM  (Meropenem  1000 mg /ml injection) and reference drug Meronem IV in patients with bacterial infections.

A total of 60 subjects would be enrolled for the study  for 14 days.


The data will be analyzed for non - inferiority with 5 % significance level and 80% power for study using SAS. The difference within the group will be assessed using paired T -Test. The difference between the groups will be assessed using independent T-Test.

 
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