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
|
|
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
|
|
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. |