| CTRI Number |
CTRI/2025/10/095526 [Registered on: 01/10/2025] Trial Registered Prospectively |
| Last Modified On: |
14/07/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical trial to evaluate safety of early de-escalation of antibiotics in children with cancer based on procalcitonin levels |
|
Scientific Title of Study
|
Comparative study of procalcitonin guided early de-escalation versus conventional antimicrobial therapy in children with high-risk febrile neutropenia receiving cancer chemotherapy |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Aditi Sharma |
| Designation |
PG Resident |
| Affiliation |
Vardhaman Mahavir Medical College, Safdarjung Hospital New Delhi 110029 |
| Address |
Vardhaman Mahavir Medical College, Safdarjung Hospital New Delhi 110029
New Delhi
DELHI
110029
India |
| Phone |
9717253399 |
| Fax |
|
| Email |
sharma274aditi@gmail.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr Pradeep K Debata |
| Designation |
Professor and Head of Department, Department of Pediatrics |
| Affiliation |
Professor and Head of Department, Department of Pediatrics |
| Address |
Head of Department office, Ward 21, 3rd floor ,H block, Safdarjung Hospital New Delhi 110029
New Delhi
DELHI
110029
India |
| Phone |
7291000664 |
| Fax |
|
| Email |
drpkdebata@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Aditi Sharma |
| Designation |
PG resident |
| Affiliation |
Vardhaman Mahavir Medical College, Safdarjung Hospital New Delhi 110029 |
| Address |
Vardhaman Mahavir Medical College, Safdarjung Hospital New Delhi 110029
New Delhi
DELHI
110029
India |
| Phone |
9717253399 |
| Fax |
|
| Email |
sharma274aditi@gmail.com |
|
|
Source of Monetary or Material Support
|
| VARDHAMAN MAHAVIR MEDICAL COLLEGE , SAFDARJUNG HOSPITAL NEW DELHI 110029 |
|
|
Primary Sponsor
|
| Name |
VARDHAMAN MAHAVIR MEDICAL COLLEGE SAFDARJUNG HOSPITAL NEW DELHI |
| Address |
VARDHAMAN MAHAVIR MEDICAL COLLEGE SAFDARJUNG HOSPITAL NEW DELHI 110029 |
| Type of Sponsor |
Government medical college |
|
|
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 Aditi Sharma |
Safdarjung Hospital New Delhi |
Ward 21
3rd floor H block
Vardhman Mahavir Medical college Safdarjung Hospital
New Delhi
110029
South
DELHI |
9717253399
sharma274aditi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Comittee VMMC and Safdarjung Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C00-D49||Neoplasms, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Procalcitonin Guided early de-escalation of empirical antibiotics |
Children with high-risk febrile neutropenia will be admitted and started on iv antibiotics which usually includes combination therapy with empirical first line intravenous antibiotics 14(Piperacillin-Tazobactam with Amikacin).Children with high-risk febrile neutropenia will be admitted and started on iv antibiotics which usually includes combination therapy with empirical first line intravenous antibiotics 14(Piperacillin-Tazobactam with Amikacin).Baseline investigations will be sent as part of pre-study workup
A 2ml serum sample will also be taken for Procalcitonin (PCT) estimation
.Early de-escalation of empirical antibiotics from iv to oral (at 72 hours). Oral antibiotics will be continued until recovery of neutropenia i.e., ANC 500/microliter
Amoxicillin-Clavulanate and Levofloxacin. (Amoxicillin @ 40-50mg/kg/day in 2-3 divided doses and Levofloxacin 5years: 8-10 mg/kg/day in 2 divided doses; 5years :8-10 mg/kg/day OD).Oral antibiotics will be continued until recovery of neutropenia i.e., ANC 500/microliter. |
| Comparator Agent |
Standard therapy |
Control arm
Standard therapy with continuation of antibiotics until recovery of neutropenia i.e., ANC 500/microliter ANC will be ascertained by repeat CBC every 2/3 days or as and when needed till 10 days of randomization. |
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
14.00 Year(s) |
| Gender |
Both |
| Details |
All children aged 3-14 years with hematolymphoid malignancies (ALL on Intensive phase of chemotherapy, AML, NHL) on chemotherapy and presenting with high- risk Febrile neutropenia, started on empirical antimicrobial therapy will be enrolled at 96 hours of presentation when they fulfill the following criteria -Sterile blood culture at 48 boursNegative Procalcitonin value (less than 0.5ng/ml) or more than 80% reduction in Procalcitonin value from baseline at 72 hours. 4. With an afebrile period for at least 24 hours (without antipyretics)No evidence of marrow recovery (Absolute Neutrophil Counts less than 500 per microliter) |
|
| ExclusionCriteria |
| Details |
1. 2. 3. Hemodynamically unstable at time of presentation Clinically documented infections/sepsis which require prolonged duration of antibiotics like pneumonia, septic arthritis, meningitis, osteomyelitis, Neutropenic enterocolitis.Microbiological evidence of infection (Blood culture showing growth of microorganism)4. Radiological evidence of any focus of infection |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the recurrence of fever within first 10 days of being afebrile after discharge among children receiving cancer chemotherapy and being treated for high risk febrile neutropenia |
Every 48 hours till 10 days of being afebrile after discharge or as per scheduled visits for chemotherapy or if danger signs appear |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare the mean duration ofantibiotic exposure between the two groups
To compare the mean duration taken for ANC recovery (more than 500/microliter) between the two groups.
To compare the all-cause mortality between the two groups
To study the prognostic value of -Procalcitonin (PCT) levelsProcalcitonin (PCT), quantitative C-C- Reactive protein Reactive Protein (CRP) in Febrile Neutropenia. |
First 10 days of being afebrile |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
15/10/2025 |
| 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="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
The study design will be a single-center, randomized, non-inferiority trial. The study will be conducted over 18 months period among children diagnosed with cancer and being managed under Department of Pediatrics, VMMC and Safdarjung Hospital, New Delhi. Children with high-risk febrile neutropenia will be admitted and started on iv antibiotics. The parents will be instructed to record temperature at least 3 times daily and also whenever the child is febrile and maintain a temperature record for review. The children will be reviewed again at 72 hours of starting empirical antibiotics and samples for PCT will be taken along with other investigations.Children will be randomized into two groups, after getting consent for the study. Intervention arm- Early de-escalation of empirical antibiotics from iv to oral (at 72 hours). Oral antibiotics will be continued until recovery of neutropenia i.e., ANC more than 500/microliter. Standard arm-Standard therapy with continuation of antibiotics until recovery of neutropenia which is ANC more than 500/microliter .Children belonging to both the groups will be followed clinically for recurrence of feverwithin first 10 days of being afebrile after discharge for primary and secondary outcomes. |