| CTRI Number |
CTRI/2025/09/095414 [Registered on: 26/09/2025] Trial Registered Prospectively |
| Last Modified On: |
25/09/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to find out if giving levofloxacin prevents infections in children and teenagers (1 to 18 years) receiving treatment for blood cancers (leukemia and lymphoma) |
|
Scientific Title of Study
|
The Efficacy and Safety of Prophylactic Levofloxacin in reducing the incidence of Febrile Neutropenia and Bacterial Infection during Induction and Consolidation Chemotherapy in Pediatric patients aged 1 to 18 years with Acute Lymphoblastic Leukemia (ALL) and Lymphoma: A randomized controlled trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Anurag Mohanty |
| Designation |
Senior Resident (Academic) |
| Affiliation |
AIl India Institute of Medical Sciences, Bhopal |
| Address |
Division of Pediatric Hematology and Oncology, Department of Pediatrics,
All India Institute of Medical Sciences, Saket Nagar, Habib Ganj, Bhopal
Division of Pediatric Hematology and Oncology, Department of Pediatrics,
All India Institute of Medical Sciences, Saket Nagar, Habib Ganj, Bhopal
Bhopal
MADHYA PRADESH
462020
India |
| Phone |
8895594424 |
| Fax |
|
| Email |
anuragmohanty31@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Narendra Kumar Chaudhary |
| Designation |
Additional Professor |
| Affiliation |
AIIMS,Bhopal |
| Address |
Division of Pediatric Hematology and Oncology, Department of Pediatrics,
All India Institute of Medical Sciences, Saket Nagar, Habib Ganj, Bhopal
Division of Pediatric Hematology and Oncology, Department of Pediatrics,
All India Institute of Medical Sciences, Saket Nagar, Habib Ganj, Bhopal
Bhopal
MADHYA PRADESH
462020
India |
| Phone |
9443350635 |
| Fax |
|
| Email |
narendra.pediatrics@aiimsbhopal.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Narendra Kumar Chaudhary |
| Designation |
Additional Professor |
| Affiliation |
AIIMS,Bhopal |
| Address |
Division of Pediatric Hematology and Oncology, Department of Pediatrics,
All India Institute of Medical Sciences, Saket Nagar, Habib Ganj, Bhopal
Division of Pediatric Hematology and Oncology, Department of Pediatrics,
All India Institute of Medical Sciences, Saket Nagar, Habib Ganj, Bhopal
Bhopal
MADHYA PRADESH
462020
India |
| Phone |
9443350635 |
| Fax |
|
| Email |
narendra.pediatrics@aiimsbhopal.edu.in |
|
|
Source of Monetary or Material Support
|
| Department of Pediatrics,
All India Institute of Medical Sciences, Saket Nagar, Habib Ganj, Bhopal, Madhya Pradesh, India, PIN- 462020 |
|
|
Primary Sponsor
|
| Name |
AIIMS Bhopal |
| Address |
AIIMS Bhopal,AIIMS Road, Saket Nagar, Habib Ganj, Bhopal, Pin 462020 |
| 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 |
| Anurag Mohanty |
AIl India Institute of Medical Sciences, Bhopal |
Department of Pediatrics
Bhopal
MADHYA PRADESH |
8895594424
anuragmohanty31@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Human Ethics Committee- Student Research (IHEC-SR), AIIMS, Bhopal |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C910||Acute lymphoblastic leukemia [ALL], |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Levofloxacin |
Levofloxacin will be given prophylactically in the intervention arm along with standard care according to the Indian Childhood Collaborative Leukaemia (ICiCLe) group protocol. Levofloxacin Oral suspension or Tablets (10 mg/kg/day, maximum 500 mg/day, once daily for ages more than 5 years and in 2 divided doses for ages less than 5 years) for a duration starting from induction chemotherapy to 7 days after completion of consolidation chemotherapy |
| Comparator Agent |
No levofloxacin |
The comparator arm will receive standard care as per the Indian Childhood Collaborative Leukaemia (ICiCLe) group protocol. |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
Pediatric patients aged 1–18 years diagnosed with ALL, scheduled to undergo induction and consolidation chemotherapy as per standardized ALL protocol (ICiCLe protocol), Ability to swallow oral medication or tolerate administration via nasogastric tube
|
|
| ExclusionCriteria |
| Details |
Known hypersensitivity to levofloxacin or other fluoroquinolones, History of Myasthenia Gravis or tendon disorder, Severe renal impairment (eGFR less than 30 mL/min/1.73 m²), Concurrent use of other prophylactic antibiotics (except for Pneumocystis jirovecii prophylaxis).
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Incidence of Febrile Neutropenia |
From the start of induction chemotherapy to 7days after the consolidation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Febrile neutropenia (bacterial, fungal, or viral), neutropenic infection without fever, non-neutropenic infection (bacterial, fungal, or viral), focus of infection including bloodstream infections, urinary tract infections, pneumonia, meningitis, skin & soft tissue infections, osteomyelitis & other infections confirmed by culture or molecular diagnostics, organism wise comparison of infections, adverse events graded per Common Terminology Criteria for Adverse Events with focus on musculoskeletal toxicity, hepatotoxicity & nephrotoxicity, chemotherapy delays (in days) due to febrile neutropenia or infections, duration of intensive care unit stay for infective causes if any, duration of hospitalization, treatment related mortality within 30 days of a febrile neutropenia episode, antibacterial resistance pattern |
From the start of induction chemotherapy to 7days after the consolidation |
|
|
Target Sample Size
|
Total Sample Size="102"
Sample Size from India="102"
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)
|
10/10/2025 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Title:
Efficacy and Safety of Prophylactic Levofloxacin in Reducing Febrile Neutropenia during Chemotherapy in Pediatric ALL and Lymphoma: A Randomized Controlled Trial Background: -
Acute Lymphoblastic Leukemia (ALL) is the most common childhood cancer. -
In India, infection-related complications during chemotherapy-induced neutropenia remain a leading cause of morbidity, mortality, and treatment delays. -
Febrile Neutropenia (FN) incidence in Indian children during induction is 60–80%, often due to gram-negative infections. -
Levofloxacin prophylaxis has shown benefit internationally but its role in Indian settings with high antimicrobial resistance and resource constraints is unclear. Aim:
To evaluate whether prophylactic levofloxacin reduces FN and bacterial infections during induction and consolidation chemotherapy in children with ALL/Lymphoma. Methodology: -
Design: Open-label, randomized controlled trial. -
Participants: 102 children (1–18 years) with newly diagnosed ALL/Lymphoma (51 per arm). -
Intervention: Levofloxacin 10 mg/kg/day (max 500 mg), oral, from start of induction until 7 days after consolidation. -
Control: Standard of care without levofloxacin prophylaxis. -
Primary Outcome: Incidence of FN. -
Secondary Outcomes: Infection rates, antibiotic use, hospitalization/ICU stay, chemotherapy delays, mortality, and resistance patterns. -
Analysis: SPSS v23, significance at p < 0.05. Ethics & Safety: Expected Impact: -
Generate India-specific evidence for levofloxacin prophylaxis. -
Potential to reduce FN burden, improve chemotherapy compliance, cut costs, and enhance survival in pediatric ALL in resource-limited settings. |