| CTRI Number |
CTRI/2010/091/000484 [Registered on: 08/06/2010] |
| Last Modified On: |
28/02/2013 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
Type of Study
Modification(s)
|
Follow Up Study |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical trial to compare the efficacy and safety of fixed dose combination of cefoperazone and tazobactam with cefoperazone alone in infections caused by Gm(-ve) organisms. |
|
Scientific Title of Study
|
A multicentre,single blind, comparative clinical trial to compare the efficacy and safety of FDC of cefoperazone and tazobactam and cefoperazone alone in infections caused by Gm(-ve) organisms. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prof.(Dr.) Tapan Kumar Pal |
| Designation |
|
| Affiliation |
|
| Address |
Bioequivalence Study Centre, Dept. of Pharmaceutical Technology, Jadavpur University, Kolkata, India
Kolkata
WEST BENGAL
700032
India |
| Phone |
(033) 24146967. Mob: 09830036297 |
| Fax |
(033)24146186/6266 |
| Email |
tkpal12@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof.(Dr.) Tapan Kumar Pal |
| Designation |
|
| Affiliation |
|
| Address |
Bioequivalence Study Centre, Dept. of Pharmaceutical Technology, Jadavpur University, Kolkata, India
Kolkata
WEST BENGAL
700032
India |
| Phone |
(033) 24146967. Mob: 09830036297 |
| Fax |
(033)24146186/6266 |
| Email |
tkpal12@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof.(Dr.) Tapan Kumar Pal |
| Designation |
|
| Affiliation |
|
| Address |
Bioequivalence Study Centre, Dept. of Pharmaceutical Technology, Jadavpur University, Kolkata, India
Kolkata
WEST BENGAL
700032
India |
| Phone |
(033) 24146967. Mob: 09830036297 |
| Fax |
(033)24146186/6266 |
| Email |
tkpal12@gmail.com |
|
|
Source of Monetary or Material Support
|
|
Bioequivalence Study Centre,
Dept. of Pharmaceutical Technology, Jadavpur University, Kolkata
|
| M/s Kilitch Drugs(India) Ltd., 37-41, Ujagar Industrial Estate, W. T. Patil Marg, Deonar, Mumbai-400088
|
|
Primary Sponsor
Modification(s)
|
| Name |
Ms Kilitch DrugsIndia Ltd |
| Address |
37-41, Ujagar Industrial Estate, W. T. Patil Marg, Deonar, Mumbai-400088 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Bioequivalence Study Centre,
Dept. of Pharmaceutical Technology, Jadavpur University, Kolkata-700032.
&
TAAB Biostudy Services,
27, Central Road, Jadavpur, Kolkata-700032
|
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 4 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr. Balaram Ghosh |
Bankura Sammilani Medical College |
Govt. of W. B., ,-
Bankura
WEST BENGAL |
09433412788
drbrghosh@gmail.com |
| Dr. T. K. Chattaraj |
Dafodil Nursing Home Pvt. Ltd. |
Dafodil Nursing Home Pvt. Ltd., 276 Canal Street, ,-700048
Kolkata
WEST BENGAL |
(033) 25346649/5681
|
| Dr. R. G. Bhagat |
Dr. Bhagat?s Allergy- Asthma Clinic And Respiratory Care Centre, ?Pathik?, |
Dashaporwad Society,Gajarawala Flat?s Lane, B/h. Paldi Bus Stand, Paldi-380007
Ahmadabad
GUJARAT |
(079) 26574746
|
| Dr. Debasish Deb |
KPC Medical College & Hospital |
1F Raja S C Mullick Road,Jadavpur-700032
Kolkata
WEST BENGAL |
09830050226
|
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 4 |
| Name of Committee |
Approval Status |
| COMSART (Dr. Balaram Ghosh) |
Approved |
| COMSART (Dr. Debasish Deb) |
Approved |
| COMSART (Dr. R. G. Bhagat) |
Approved |
| Institutional Ethics Committee, Jadavpur University |
Approved |
|
Regulatory Clearance Status from DCGI
Modification(s)
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
Gm (-ve) infections with culture showing the organisms., |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Cefoperazone 1000mg/500mg |
7 to 14 days |
| Intervention |
FDC of Cefoperazone 1000mg/500mg+ Tazobactum125mg/62.5mg |
7 to 14 days |
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Male and female subjects in the aged group of 18-60 years shall be selected.
2. Clinically diagonised subjects with gm (-ve) infections with culture showing the organisms.
3. Subjects willing to give informed consent.
4. Patient must not have received any antibiotics in previous 4 weeks.
|
|
| ExclusionCriteria |
| Details |
1. History of hypersensitivity reaction or any specific groups.
2. Presence of severe hepatic or renal disorders.
3. Pregnancy or lactation.
4. History of hearing loss.
5. Previous history seizure.
6. Alcoholic.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Clinical improvement and bacteriological conversion(when applicable) are the primary outcome and are defined as a subject who is
- afebrile for 48 hours.
- Improvement of X-ray lesion in lower respiratory tract infection as compared to pretreatment.
- Isolation tests show the reduction or absence of infecting organisms detected in initial cultures on 48 hours, 7 days, 14 days of treatment and again 7 days after discontinuation of injectable antibacterial treatment.
|
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The time for complete resolution defined as
- complete resolution of all symptoms of infection.
- The number of days after beginning treatment with FDC of cefoperazone & tazobactam or cefoperazone alone to discharge.
|
|
|
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
Date Missing |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
10/01/2010 |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is a comparative, Single blind, multi-centre trial, comparing the safety and efficacy of FDC containing cefoperazone & tazobactam and cefoperazone alone twice daily for 7-14 days in 200 patients with infections caused by Gm (-ve) organisms that will be conducted in four centers in India. The primary outcome measures will be clinical improvement and bacteriological conversion (when applicable). The secondary outcome will be complete resolution of all symptoms of infections. |