Levofloxacin Prophylaxis to Prevent First Febrile Neutropenia in Pediatric ALL During Induction Phase

Sponsor
Gadjah Mada University
Study ID
NCT07320534
Phase
PHASE4
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

Eligibility Criteria

Sex
ALL
Age
6 Months - 18 Years
Healthy Volunteers
Not accepted

Interventions

  • Levofloxacin — DRUG
    younger than 5 years received levofloxacin 10 mg/kg by mouth every 12 hours and patients 5 years and older received 10 mg/kg by mouth once daily (maximum 500 mg/dose)
  • Placebo — OTHER
    Receiving oral placebo at the same dosage as the treatment group.

Study Details

The goal of this clinical trial is To evaluate the benefit of levofloxacin prophylaxis in prolonging the median time to first febrile neutropenia in pediatric ALL patients during induction phase. It will also learn about the safety of levofloxacin during induction treatment. The main questions it aims to answer are: * Does levofloxacin prophylaxis increase the median time to the first febrile neutropenia episode compared to placebo? * What are the rates of fever, severe infection, organ-related bacterial infection, and mortality in children receiving levofloxacin compared to placebo? Researchers will compare oral levofloxacin to a placebo (a look-alike substance with no active drug) to see if levofloxacin is effective in preventing infection during induction chemotherapy. Participants will: * Be children aged 1 to 18 years with ALL undergoing induction chemotherapy. * Be randomly assigned to receive either levofloxacin prophylaxis or placebo during the induction phase. * Have regular checkups, physical exams, and laboratory tests during induction. * Be monitored for fever, febrile neutropenia, severe infections, bacterial infections, and mortality. * Stop prophylaxis once the first febrile neutropenia occurs or induction therapy is completed.

Key Dates

First listed
Jan 6, 2026
Start date
Jan 1, 2026
Status verified
Jan 2026
Primary completion
Jul 31, 2026
Completion
Aug 31, 2026

Study Design

Enrollment
124 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Group A: Levofloxacin
    Receiving oral levofloxacin as infection prophylaxis during the induction phase, with the following dosage: * Age \< 5 years: 10 mg/kg PO every 12 hours (maximum 250 mg/dose) * Age ≥ 5 years: 10 mg/kg PO once daily (maximum 500 mg/day)
  • Placebo Comparator: Group B: Placebo
    Receiving oral placebo at the same dosage as the treatment group.

Primary Outcome Measure

Median time to first febrile neutropenia [ Time Frame: First febrile neutropenia up to day 63 ]

Central Contacts

Find similar trials

Nationwide
Leukemia (other) trialsOncology trialsBlood cancer trials

Related Studies