| CTRI Number |
CTRI/2008/091/000060 [Registered on: 07/05/2008] |
| Last Modified On: |
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| Post Graduate Thesis |
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| Type of Trial |
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Type of Study
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| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
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Public Title of Study
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A clinical trial to study the safety and efficacy of combination drug, vancomycin and ceftriaxone compared to vancomycin in mild to severe bacterial infections |
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Scientific Title of Study
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“An Open Labelled, Double Arm, Randomized, Multicentric, Prospective And Comparative, Phase-III Trial To Evaluate The Safety And Efficacy Of Fixed Dose Combination Of Ceftriaxone And Vancomycin Injection Vs. Vancomycin Injection In Subjects With Various Bacterial Infections.†|
| Trial Acronym |
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Secondary IDs if Any
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| Secondary ID |
Identifier |
| NIL |
NIL |
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr. Shishir Rastogi(Prof. and HOD) |
| Designation |
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| Affiliation |
|
| Address |
( Orthopaedics Department)Ansari Road
AIIMS
New Delhi
DELHI
110029
India |
| Phone |
9868397102 |
| Fax |
|
| Email |
rustogi@hotmail.com |
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Details of Contact Person
Scientific Query
|
| Name |
Dr. Namit Saraf( Senior Doctor) |
| Designation |
|
| Affiliation |
|
| Address |
( Orthopaedics Department)Ansari Road
AIIMS
New Delhi
DELHI
110029
India |
| Phone |
09891290198 |
| Fax |
|
| Email |
drnamitsaraf@rediffmail.com |
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Details of Contact Person
Public Query
|
| Name |
Mahesh Mudgal |
| Designation |
|
| Affiliation |
|
| Address |
Flat No: 90, Pocket A
Sector - 14, Dwarka
New Delhi
DELHI
110075
India |
| Phone |
09958007941 |
| Fax |
|
| Email |
maheshmudgal@nexuscro.com |
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Source of Monetary or Material Support
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| Venus Remedies Limited 51-52, Industrial Area, Phase 1, Panchkula, 134112 Haryana |
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Primary Sponsor
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| Name |
Venus Remedies Limited |
| Address |
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| Type of Sponsor |
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Details of Secondary Sponsor
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Countries of Recruitment
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India |
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Sites of Study
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| No of Sites = 5 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr. Namit Saraf |
AIIMS |
Ansari Road,AIIMS-110029
New Delhi
DELHI |
09891290198
drnamitsaraf@rediffmail.com |
| Dr. Deepak Bhambe |
Dr. Hedgewar Arogya Sansthan |
Karkardooma,-
New Delhi
DELHI |
09212052184
|
| Dr. M.G. Gopal |
Kempegowda Institute of Medical Sciences |
2nd phase,,Banashankri-560078
Bangalore
KARNATAKA |
09845010455
|
| Dr. N.T. Awad |
Lokmanya Tilak Medical College |
Sion,-
Mumbai
MAHARASHTRA |
0222407 6381
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| Dr. R.B. Panwar |
S.P. Medical College |
Bikaner,-334003
Bikaner
RAJASTHAN |
01512226300
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Details of Ethics Committee
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| No of Ethics Committees= 5 |
| Name of Committee |
Approval Status |
| Central Independent Ethics Committee |
Approved |
| Ethics Committee, Kempegowda Institute of Medical Science, Bangalore |
Submittted/Under Review |
| Ethics Committee, Lokmanya Tilak Medical College, Sion, Mumbai |
Approved |
| Ethics Committee, S.P. Medical College and Associated Group of Hospitals, Bikaner |
Approved |
| Institutional Review Board, AIIMS |
Submittted/Under Review |
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
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| Health Type |
Condition |
| Patients |
Mild to severe Bacterial infections( in Lower Respiratory Tract infection, Endocarditis, Skin infection, Meningitis, Bone infection.), |
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Intervention / Comparator Agent
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| Type |
Name |
Details |
| Comparator Agent |
VANCOMYCIN |
2 g divided either as 500 mg every 6 hours or 1 g every 12 hours. |
| Intervention |
Vancomycin and Ceftriaxone combined |
6 gm i.v in two equally
divided slow doses, depending on the severity of disease |
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Inclusion Criteria
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| Age From |
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| Age To |
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| Gender |
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| Details |
All subjects aged between 18 and 70 years.
Diagnosed subjects of infectious disease (on clinical evaluation).
Subjects willing to give informed consent.
Subject suffering from any of the following infections- Lower respiratory tract infections, skin and skin structure infections, endocarditic, bacterial meningitis and bone infection.
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| ExclusionCriteria |
| Details |
History of hypersensitivity reaction or any specific contraindication to penicillin group of drugs or Ceftriaxone or Vancomycin.
Presence of hepatic or renal disorder
Pregnancy&/or lactation
Alcoholics |
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Method of Generating Random Sequence
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Computer generated randomization |
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Method of Concealment
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Not Applicable |
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Blinding/Masking
|
Not Applicable |
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Primary Outcome
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| Outcome |
TimePoints |
| compare the efficacy of a 3.0g FDC of Ceftriaxone and Vancomycin Injection Vs. 1.0g Vancomycin Injection in subjects with Mild to Severe Bacterial infections. |
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Secondary Outcome
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| Outcome |
TimePoints |
| evaluate the safety of the test and comparative product |
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Target Sample Size
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Total Sample Size="200"
Sample Size from India=""
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
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Phase of Trial
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Phase 3 |
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Date of First Enrollment (India)
|
Date Missing |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
08/04/2008 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
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Estimated Duration of Trial
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Years="0"
Months="6"
Days="0" |
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Recruitment Status of Trial (Global)
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Open to Recruitment |
| Recruitment Status of Trial (India) |
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Publication Details
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Individual Participant Data (IPD) Sharing Statement
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Will individual participant data (IPD) be shared publicly (including data dictionaries)?
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Brief Summary
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This is a open-labeled,double arm, randomized,multi-centric, trial TO EVALUATE THE SAFETY AND EFFICACY OF FIXED DOSE COMBINATION OF CEFTRIAXONE AND VANCOMYCIN INJECTION Vs. VANCOMYCIN INJECTION IN SUBJECTS WITH VARIOUS BACTERIAL INFECTIONS with 200 patients for 6 months that will be conducted in five centres in India. |