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

StatusTerminated
PhasePhase 4
Started
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Record History

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  1. Trial status changed: Not Yet Recruiting → Terminated Sponsor's reason: Interim analysis showed no significant benefit of levofloxacin. Prolonged antibiotic use may increase adverse effects and resistance. Limited funding and the approaching end of the study period also supported early termination. Show 7 more changesShow less
    • Final enrollment: 49 participants (planned 124)
    • Primary completion date changed from estimate of Jul 31, 2026 to Aug 31, 2026
    • Study completion date changed from estimate of Aug 31, 2026 to Sep 13, 2026
    • Eligibility criteria expanded, about 6 words
    • Site contact updated
    • Publications: details revised at 2 of 2 entries
    • Study description expanded, about 5 words
  2. Eligibility criteria shortened, about 2 wordsv2
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07320534
Lead Sponsor Gadjah Mada University
Collaborators: Dr. Sardjito Hospital, Yogyakarta
Conditions
(from sponsor)		 Neutropenic Fever, Acute Lymphoblastic Leukemia
Related terms Febrile Neutropenia, Precursor Cell Lymphoblastic Leukemia-Lymphoma
Enrollment 49 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov