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CTRI Number  CTRI/2024/01/061533 [Registered on: 16/01/2024] Trial Registered Prospectively
Last Modified On: 06/01/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   observational retrospective study 
Study Design  Other 
Public Title of Study   Study of impact of stool surveillance cultures for managing infections in allogeneic stem cell transplant patients 
Scientific Title of Study   Pattern of sensitivity and resistance of stool surveillance over 13 years in a tertiary cancer centre and impact of stool surveillance guided selection of antibiotics during neutropenic sepsis in patients undergoing allogeneic HSCT 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Akanksha Chichra 
Designation  Associate Professor 
Affiliation  Advanced Centre for Treatment Research and Education in Cancer  
Address  BMT OPD room no 211 paymaster shodhika Advanced Centre for Treatment Research and Education in Cancer Sector 22 Utsav Chowk CISF Road Owe Camp Kharghar Navi Mumbai

Raigarh
MAHARASHTRA
410210
India 
Phone  9004920555  
Fax    
Email  akanksha7@hotmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Keshav Garg 
Designation  Senior resident  
Affiliation  Advanced Centre for Treatment Research and Education in Cancer  
Address  BMT OPD room no 307 and 306 paymaster shodhika Advanced Centre for Treatment Research and Education in Cancer Sector 22 Utsav Chowk CISF Road Owe Camp Kharghar Navi Mumbai

Raigarh
MAHARASHTRA
410210
India 
Phone  02227405000  
Fax    
Email  garg488keshav@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Keshav Garg 
Designation  Senior resident  
Affiliation  Advanced Centre for Treatment Research and Education in Cancer  
Address  BMT OPD room no 307 and 306 paymaster shodhika Advanced Centre for Treatment Research and Education in Cancer Sector 22 Utsav Chowk CISF Road Owe Camp Kharghar Navi Mumbai

Raigarh
MAHARASHTRA
410210
India 
Phone  02227405000  
Fax    
Email  garg488keshav@gmail.com  
 
Source of Monetary or Material Support  
Advanced Centre for Treatment, Research and Education in Cancer, Tata Memorial Centre  
 
Primary Sponsor  
Name  Tata Memorial Centre  
Address  Dr Ernest Borges Rd, Parel East, Mumbai Maharashtra 400012  
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Akanksha Chichra  Advanced Centre for Treatment, Research and Education in Cancer, Tata Memorial Centre  BMT OPD room no 307 and 306, Shanti Sadan, Sector 22 Utsav Chowk CISF Road Owe Camp Kharghar Navi Mumbai, 410210
Raigarh
MAHARASHTRA 
9004920555

akanksha7@hotmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Tata Memorial Centre- Advanced Centre for Treatment, Research and Education in Cancer, Institutional Ethics Committee (TMC-IEC III)   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: D898||Other specified disorders involving the immune mechanism, not elsewhere classified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Comparator Agent  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  All patients admitted for allogenic hematopoietic stem cell transplant from January 2008 to December 2020 
 
ExclusionCriteria 
Details  Patients having active gastrointestinal bleed at the time of allogenic hematopoietic stem cell transplant.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
-Time to defervescence in all groups Pansensitive, ESBL, MDR,VRE
-Time to defervescence according to empirical antibiotic use versus surveillance stool culture guided 1st line antibiotics
 
3 months  
 
Secondary Outcome  
Outcome  TimePoints 
-Time to change to second line antibiotics.
-Concordance rate between blood culture during first febrile neutropenia episode and baseline stool surveillance culture.
-Change in surveillance stool culture from pan sensitive to ESBL or CRO
-Change in surveillance stool culture from ESBL at baseline to CRO
-Change in surveillance stool culture from VSE to VRE
-To study change in pattern of stool sensitivity in 2 time periods 1st January 2008 to 31st December 2014 and 1st January 2015 to 31st December 2020
-Correlation of change in stool sensitivity pattern in the first 100 days with OS
-Correlation of change in stool sensitivity pattern in the first 100 days with gut GVHD or any GVHD
 
3 months  
 
Target Sample Size   Total Sample Size="358"
Sample Size from India="358" 
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   N/A 
Date of First Enrollment (India)   24/01/2024 
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="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Introduction 

The human gut contains a diverse range of bacteria which have many varied functions. The functions include maintaining a healthy gut immune system and killing harmful microorganisms.

Allogeneic hematopoietic stem cell transplant (HSCT) involves use of high dose chemotherapy and radiotherapy which damages the gut tissue and predisposes patients to infections and gut graft versus host disease.

A significant proportion of allogeneic HSCT patients will develop bacterial infections which leads to prolonged hospital stay and sometimes death. There is a worldwide rise in infections with multidrug resistant organisms. This is particularly a problem of our country where we have seen a steady rise in multidrug resistant organism infections.

There is a need to minimize the upfront use of higher antibiotics in all HSCT patients to restrict the development of antibiotic resistance.   

 

What is the rationale of this trial?

In our unit we send stool surveillance cultures in all our patients undergoing allogeneic HSCT weekly. Antibiotic strategy during the episode of fever in pre-engraftment period in HSCT patients can be of two type i.e. empirical or based on the pretransplant surveillance stool cultures.

Empirical strategy is defined, in context, as giving an initial empirical regimen (e.g. cefeperazone and aminoglycoside, or single agent piperacillin-tazobactam) that covers most sensitive organisms. If the fever persists or if the patient deteriorates, or a resistant pathogen is isolated, therapy is ‘escalated’ to an antibiotic or a combination with a broader spectrum. On the contrary, the second strategy employs antibiotics based on the surveillance cultures.

We would like to study the stool colonization patterns in our patients undergoing allogeneic HSCT and the impact of using empirical versus stool guided antibiotic policy on the fever episodes of these patients.

We would also like to study the pattern of stool sensitivity in our HSCT patients over the last 13 years to better understand the emergence of multi drug resistant organisms.

With the above-mentioned facts and hypothesis, we propose a retrospective analysis of all the allogenic hematopoietic stem cell transplants done at our centre from January 2008 to December 2020, analyzing the Pattern of sensitivity and resistance of stool surveillance over 13 years in a tertiary cancer centre and impact of stool surveillance guided selection of antibiotics during neutropenic sepsis in patients undergoing allogeneic HSCT.

 
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