| CTRI Number |
CTRI/2022/11/047325 [Registered on: 15/11/2022] Trial Registered Prospectively |
| Last Modified On: |
11/11/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To study the effect of a new drug in treatment of complicated urinary tract infections. |
|
Scientific Title of Study
|
Effect of ceftriaxone sulbactam disodium EDTA combination in treatment of complicated urinary tract infection caused by metallo beta-lactamase producing gram negative bacilli an open label randomised controlled trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
mahendra kumar garg |
| Designation |
professor and head dept of general medicine aiims jodhpur |
| Affiliation |
aiims jodhpur |
| Address |
dept of general medicine aiims jodhpur
aiims jodhpur dept of general medicine
Jodhpur
RAJASTHAN
342005
India |
| Phone |
9438478537 |
| Fax |
|
| Email |
mkgargs@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
mahendra kumar garg |
| Designation |
professor and head dept of general medicine aiims jodhpur |
| Affiliation |
aiims jodhpur |
| Address |
dept of general medicine aiims jodhpur
aiims jodhpur dept of general medicine
Jodhpur
RAJASTHAN
342005
India |
| Phone |
9438478537 |
| Fax |
|
| Email |
mkgargs@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Subhashree Samantaray |
| Designation |
DM Infectious diseases Resident |
| Affiliation |
AIIMS, Jodhpur |
| Address |
1B, OPD block, Department of General Medicine (Infectious Diseases), AIIMS, Jodhpur campus, Basni Industrial estate, Basni, Rajasthan
Flat no. 303, Block-A, Mangaldeep Pal Balaji Apartment, Pal road, Jodhpur, Rajasthan.
Jodhpur
RAJASTHAN
342005
India |
| Phone |
9438478537 |
| Fax |
|
| Email |
subhashree.bbsr@gmail.com |
|
|
Source of Monetary or Material Support
|
| aiims jodhpur basni rajasthan pincode 342005 |
|
|
Primary Sponsor
|
| Name |
cipla pharmaceuticals |
| Address |
jodhpur |
| 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 |
| mahendra kumar garg |
aiims jodhpur |
department of medicine
Jodhpur
RAJASTHAN |
9438478537
mkgargs@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE AIIMS JODHPUR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N390||Urinary tract infection, site notspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
injection Ceftriaxone/sulbactam/disodium-edta |
route- intravenous infusion over 90 minutes
dose-3 grams in 100 ml normal saline
frequency- twice a day
duration- 5 to 14 days based on clinical response |
| Comparator Agent |
injection colistin |
route- intravenous
dose-4.5 million units
frequency- twice daily |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
COMPLICATED UTI
URINE CULTURE GROWING MBL PRODUCING GNB |
|
| ExclusionCriteria |
| Details |
MORIBUND PATIENTS
MIXED GROWTH IN CULTURE
ALLERGY TO MEDICATIONS |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| CLINICAL AND MICROBIOLOGICAL CLEARANCE OF BACTERIA FROM URINE. |
AFTER 14 DAYS OF TREATMENT |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| TO SEE RELAPSE OF BACTERIAL INFECTIONS IN COMPLICATED URINARY TRACT INFECTION CASES |
WITHIN 28 DAYS OF TREATMENT |
|
|
Target Sample Size
|
Total Sample Size="62"
Sample Size from India="62"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
15/11/2022 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Several in vitro studies have been conducted for establishing the susceptibility of the CSE drug combination among the ESBL and MBL producing GNB.The role of the drug as a Carbapenem sparing agent has been studied both in vivo and in vitro and have proven the role of CSE combination as a good alternative empirical therapy in nosocomial infections. |