| CTRI Number |
CTRI/2025/05/087605 [Registered on: 26/05/2025] Trial Registered Prospectively |
| Last Modified On: |
02/06/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Biological
Diagnostic |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Study to Test the Effectiveness of Using Rectal Swab Samples to Guide Antibiotic Treatment in Children with Blood Cancer having low white blood cell (neutrophil) counts and Fever During Their First Chemotherapy Phase |
|
Scientific Title of Study
|
Efficacy of Rectal swab culture-directed antimicrobial therapy in children with Febrile neutropenia with hematolymphoid malignancies- A phase II Randomised control non-inferiority study |
| 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 Chetan Dhamne |
| Designation |
Professor, Medical Oncology |
| Affiliation |
Tata Memorial Centre |
| Address |
Room no. 1111, 11 Floor Homi Bhabha Block Tata Memorial Hospital, Dr. Ernest Borges Road, Parel Mumbai
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9136660746 |
| Fax |
|
| Email |
chetandhamne@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Chetan Dhamne |
| Designation |
Professor, Medical Oncology |
| Affiliation |
Tata Memorial Centre |
| Address |
Room no. 1111, 11 Floor Homi Bhabha Block Tata Memorial Hospital, Dr. Ernest Borges Road, Parel Mumbai
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9136660746 |
| Fax |
|
| Email |
chetandhamne@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Chetan Dhamne |
| Designation |
Professor, Medical Oncology |
| Affiliation |
Tata Memorial Centre |
| Address |
Room no. 1111, 11 Floor Homi Bhabha Block Tata Memorial Hospital, Dr. Ernest Borges Road, Parel Mumbai
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9136660746 |
| Fax |
|
| Email |
chetandhamne@gmail.com |
|
|
Source of Monetary or Material Support
|
| Tata Memorial Hospital, Dr. Ernst Borges Road, Parel Mumbai 400012
Mumbai
MAHARASHTRA |
|
|
Primary Sponsor
|
| Name |
Tata Memorial Centre Research Administration Council TMCTRAC |
| Address |
3rd Floor, Main building, Clinical Research Secretariat, Tata Memorial Hospital, Dr. Ernst Borges Road, Parel Mumbai 400012
Mumbai
MAHARASHTRA |
| 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 Chetan Dhamne |
Tata Memorial Hospital |
R- no. 1111, 11 Floor Homi Bhabha Block Tata Memorial Hospital, Dr. Ernst Borges Road Parel Mumbai 400012
Mumbai
MAHARASHTRA
Mumbai
MAHARASHTRA |
9136660746
chetandhamne@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee-II, IRB, 3rd floor, Main Building, Tata Memorial Hospital, Dr. Ernst Borges Road Parel Mumbai 400012 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C920||Acute myeloblastic leukemia, (2) ICD-10 Condition: C910||Acute lymphoblastic leukemia [ALL], (3) ICD-10 Condition: C859||Non-Hodgkin lymphoma, unspecified, (4) ICD-10 Condition: C950||Acute leukemia of unspecified celltype, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Arm A – Personalized Antibiotic Group (De-escalation Policy) |
Children in this group will get antibiotics based on their rectal swab test results when they develop a fever during chemotherapy.
If the swab shows they carry strong, drug-resistant bacteria (MDRO), they will be given stronger antibiotics like Meropenem and Colistin.
If the swab shows regular bacteria, they will be given the standard antibiotics, Cefoperazone-sulbactam and Amikacin.
This approach helps start the right antibiotics quickly and then reduce to lighter ones if things improve — that’s why it’s called a “de-escalation” strategy.
|
| Comparator Agent |
Arm B – Standard Treatment Group (Escalation Policy) |
Children in this group will also have a rectal swab taken, but the test results will not be used to guide treatment.
When they get a fever during chemotherapy, they will be given the usual first-line antibiotics, which are Cefoperazone-sulbactam and Amikacin.
If their condition worsens or test results later show drug-resistant bacteria, stronger antibiotics may be given later.
This is called an “escalation” strategy, where treatment starts simple and becomes stronger only if needed.
|
|
Inclusion Criteria
Modification(s)
|
| Age From |
0.00 Year(s) |
| Age To |
15.00 Year(s) |
| Gender |
Both |
| Details |
1. Children less than 15 years of age
2. Diagnosed with a hematolymphoid neoplasm including Acute lymphoblastic leukemia IR and HR B-ALL or T ALL, Acute Myeloid leukemia, MPAL, Non-Hodgkins lymphoma
3. Induction phase of therapy
4. Adequate renal function is defined as a serum creatinine based on age or gender as follows:
Age Maximum serum creatinine mg per dL
Male Female
1 to 2 years 0.6 0.6
2 to 6 years 0.8 0.8
6 to 10 years 1 1
10 to 13 years 1.2 1.2
13 to 16 years 1.5 1.4
less than 16 year 1.7 1.4
5. Adequate liver function is defined as
a. Total direct bilirubin less than 1.5 times upper limit of normal for age
b. AST and ALT less than 2.5 times upper limit of normal for age
|
|
| ExclusionCriteria |
| Details |
1.Children diagnosed with Hodgkin lymphoma and Nodular lymphocyte predominant Hodgkin lymphoma (NLPHL) or Langerhans cell histiocytosis(LCH) or APL or SR- BCP ALL or Relapsed refractory leukemia or lymphoma.
2. Those with a history of MDR sepsis within 30 days before presentation
3. Any other phase of therapy (other than induction)
4. Those who do not consent or assent to participate in the study
|
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
A. Primary outcomes
1. To find out if there is a difference in the mortality rate between the two groups of children during the early phase of their cancer treatment. |
Start: When the child is enrolled in the study (about 1 week after diagnosis)
End: When the first phase of chemotherapy (induction) is completed — usually 4 to 5 weeks later
Monitored During:
Any serious infection or health worsening
End of the induction phase to check recovery status |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
B. Secondary outcomes
Estimate how often multi-drug resistant infections (bacteremia) occur in the study groups.
Compare how long children stay in the hospital due to infections between the two groups.
Compare how many children in each group need to be admitted to the Intensive Care Unit (ICU).
Check if the bacteria found in rectal swabs match those found in blood, urine, or respiratory cultures, and compare their antibiotic sensitivity.
|
How often drug-resistant blood infections happen
When we start counting: As soon as the child joins the study (around diagnosis)
When we stop counting: By the end of the first chemotherapy phase (about 4–5 weeks later)
Length of hospital stay because of infection
When we start counting: From the moment the child develops a fever with low immunity or is diagnosed with sepsis
When we stop counting: When the child goes home or the first treatment phase ends
How many children need ICU care
When we start counting: From the moment they develop a fever with low immunity or sepsis
When we stop counting: When they no longer need ICU care or when the first treatment phase ends
Whether the germs in the rectal swab match those in blood/urine/respiratory tests
When we start comparing: At the initial rectal swab (within a week of diagnosis)
When we finish comparing: When any blood, urine, or breathing-related tests are done later if an infection occurs |
C. Exploratory Outcome
Find out exactly which resistance genes the bacteria from the rectal swab carry. |
When we start: As soon as we take the first rectal swab (within a week after the child is diagnosed)
When we finish: When the lab finishes testing which antibiotics the bacteria respond to and checks the bacteria’s genes |
|
|
Target Sample Size
|
Total Sample Size="918"
Sample Size from India="918"
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)
|
03/06/2025 |
| 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 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
|
Children with cancer often have very low immunity during treatment, which makes them more likely to get serious infections. These infections can be life-threatening and also delay their cancer treatment. Some of these infections are caused by bacteria that are resistant to many antibiotics (called multi-drug resistant organisms, or MDROs), which are harder to treat. At our hospital, we usually take a rectal swab at the beginning of treatment to check what kind of bacteria are present and which antibiotics they respond to. In this study, we want to test if starting antibiotics based on this swab result can help children recover better and reduce the need for ICU admissions. This is a research study being done at TMH/ACTREC, where we will include 500 children with blood cancers. Each child will be randomly placed in one of two groups: We will compare: -
How many children get serious infections -
How many need ICU care -
The length of hospital stay -
The cost and types of antibiotics used This study will help us find out if using the swab test to guide antibiotic treatment leads to better care for children with cancer. |