| CTRI Number |
CTRI/2010/091/001046 [Registered on: 19/07/2010] |
| Last Modified On: |
06/02/2013 |
| Post Graduate Thesis |
|
| Type of Trial |
Interventional |
Type of Study
Modification(s)
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
Public Title of Study
Modification(s)
|
A clinical trial which is for various bacterial infections
|
Scientific Title of Study
Modification(s)
|
An open labeled, randomized, comparative study to evaluate the Efficacy and Safety of Etimicin Sulphate v/s Amikacin in patients suffering from various bacterial infections
|
| Trial Acronym |
|
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| Etimicin-Amika-VCRS-III/2009,Version No:03 |
Protocol Number |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Dr PK Jain |
| Designation |
|
| Affiliation |
|
| Address |
Professor & H.O.D,Department of Medicine, M.L.B.(Maharani Laxmi Bai) Medical College & Hospital ,Jhansi
Jhansi
UTTAR PRADESH
284002
India |
| Phone |
09415030010 |
| Fax |
|
| Email |
pramodkr_jain@yahoo.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Mr Pankaj |
| Designation |
|
| Affiliation |
|
| Address |
venus remedies limited Plot No- 51-52 Phase -I, Industrial Area, Panchkula (Haryana, India
Panchkula
HARYANA
134113
India |
| Phone |
01795302024 |
| Fax |
01722565566 |
| Email |
cra@venusremedies.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Mr Pankaj |
| Designation |
|
| Affiliation |
|
| Address |
Venus Remedies Limited, Plot No- 51-52 Phase -I, Industrial Area, Panchkula (Haryana)-134113,India
Panchkula
HARYANA
134113
India |
| Phone |
01795302024 |
| Fax |
01722565566 |
| Email |
cra@venusremedies.com |
|
Source of Monetary or Material Support
Modification(s)
|
| Venus Remedies Limited,
Plot No- 51-52 Phase -I, Industrial Area
Panchkula (Haryana)-134113
India
|
|
Primary Sponsor
Modification(s)
|
| Name |
Venus Remedies Limited |
| Address |
Plot No- 51-52 Phase -I, Industrial Area Panchkula (Haryana)-134113 India |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
Details of Secondary Sponsor
Modification(s)
|
|
Countries of Recruitment
Modification(s)
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 6 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr. Mahip Saluja |
Department of Pulmonary Medicine |
Associate Professor & Head Department of Pulmonary Medicine ,-
Meerut
UTTAR PRADESH |
09837360657
drmahip@hotmail.com |
| DrLP Verma |
Department of Surgery |
Govt G.R Medical College & JA Hospital,-
Gwalior
MADHYA PRADESH |
09425129676
vikranticri2007@yahoo.co.in |
| Dr. Deepak Bhambe |
Dr. Deepak Bhambe |
Narendra Prakash Health Care Clinic,DA-3/A Main Shakar pur, Laxmi Nagar-110092
New Delhi
DELHI |
011-64693332
|
| Dr. P.K. Jain |
Dr. P.K. Jain, Professor & H.O.D |
Department of Medicine, M.L.B.(Maharani Laxmi Bai) Medical College & Hospital, Jhansi, India,Nil-284002
Jhansi
UTTAR PRADESH |
09415030010
|
| Dr. SidhRaj Singh |
Dr. SidhRaj Singh |
Vaibhav Nursing Home,Kalali Chungi, Mandhi Dhanaura,Kalali Chungi, Mandhi Dhanaura-244231
|
05924-340534
|
| Dr. Tanu Raj Sirohi |
Dr. Tanu Raj Sirohi |
Medical Diirector Hope Hospital,3, Nandan Kunj, WK. Road-250001
Meerut
UTTAR PRADESH |
09917000583
|
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 6 |
| Name of Committee |
Approval Status |
| Central Independent Ethics Committee, Clinical Research India |
Approved |
| Central Independent Ethics Committee, Clinical Research India |
Approved |
| Central Independent Ethics Committee, Clinical Research India |
Approved |
| Institutional Ethics Committee, MLB Medical College & Hospital Jhansi |
Approved |
| Institutional Ethics Committee, Subarti Medical College, Meerut |
Approved |
| Institutional Ethics Committee,Govt GR Medical College & JA Hospital, Gwalior |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
bacterial infections like Urinary Tract Infections , skin and Skin structure infections, Lower respiratory tract infection,Surgical infections, |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Comparator Agent |
Amikacin |
15 mg/kg/day divided into 2 or 3 equal doses
The usual duration of treatment is 7 to 10 days
|
| Intervention |
Etimicin Sulphate |
4.5mg/kg/day for 5-10 days depending upon severity of infections |
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Male and female subjects in the age group of above 18 years till 60 years shall be selected.
Presence of an abnormal chest x-ray (CXR) as determined by the primary care team in case of LRTI patients
Clinically diagnosed subjects with Respiratory tract infections mainly LRTI (Lower respiratory tract infections) , skin & skin structure infections, UTI (Urinary tract infections), surgical infections
Patients or legal guardian or LAR (Legally acceptable representative) ready to give written informed consent.
|
|
| ExclusionCriteria |
| Details |
History of hypersensitivity reaction or any specific contraindication to Aminoglycosides or Etimicin or Amikacin
Presence of hepatic or renal disorders
History of hearing loss
Pregnant or lactating women
|
|
Method of Generating Random Sequence
Modification(s)
|
Computer generated randomization |
Method of Concealment
Modification(s)
|
Not Applicable |
Blinding/Masking
Modification(s)
|
Open Label |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
To evaluate the Efficacy of Etimicin Sulphate vs Amikacin in patients suffering from various bacterial infections
|
nil |
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
To evaluate the Safety and tolerability of Etimicin Sulphate vs Amikacin in patients suffering from various bacterial infections
|
Nil |
|
Target Sample Size
Modification(s)
|
Total Sample Size="200"
Sample Size from India="200"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
Phase of Trial
Modification(s)
|
Phase 3 |
Date of First Enrollment (India)
Modification(s)
|
Date Missing |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
06/07/2010 |
| Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
Modification(s)
|
Years="0"
Months="9"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
This an open labeled, randomized, comparative study to evaluate efficacy and safety of test drug (Etimicin Sulphate) vs Amikacin sulphate. A total of 200 patients which lies in the age group of 18 to 60 years and are suffering from various bacterial infections will be enrolled at this multi centric two arm comparative phase-3 trial. In arm A 100 patients will be treated with Etimicin 4.5mg/kg/day while another 100 patients (Arm B) will receive treatment of Amikacin 15 mg/kg/day divided into 2 or 3 equal doses administered at equally-divided intervals. The primary objective is to establish the efficacy of test drugs , while secondary objectives of the study is to confirm the safety of both the drugs. |