| 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
|
|
|
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
|
|
|
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. |