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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)

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 - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/09/095414
Enrollment
102
Registered
2025-09-26
Start date
Unknown
Completion date
Unknown
Last updated
2025-10-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: C910- Acute lymphoblastic leukemia [ALL]

Interventions

Intervention1: Levofloxacin: Levofloxacin will be given prophylactically in the intervention arm along with standard care according to the Indian Childhood Collaborative Leukaemia (ICiCLe) group proto

Sponsors

AIIMS Bhopal
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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 m ), Concurrent use of other prophylactic antibiotics (except for Pneumocystis jirovecii prophylaxis).

Design outcomes

Primary

MeasureTime frame
Incidence of Febrile NeutropeniaTimepoint: From the start of induction chemotherapy to 7days after the consolidation—

Secondary

MeasureTime frame
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 patternTimepoint: From the start of induction chemotherapy to 7days after the consolidation—

Countries

India

Contacts

Public ContactNarendra Kumar Chaudhary

AIIMS,Bhopal

narendra.pediatrics@aiimsbhopal.edu.in9443350635

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026