NCT07320534TerminatedPhase 4
Levofloxacin Prophylaxis to Prevent First Febrile Neutropenia in Pediatric ALL During Induction Phase
The Effect of Levofloxacin Prophylaxis on the First Occurrence of Febrile Neutropenia During Induction Chemotherapy in Pediatric Patients With Acute Lymphoblastic Leukemia at Dr. Sardjito Hospital
Source: ClinicalTrials.gov · Last updated 1 Oct 2026
Reason given: 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.
Brief summary (registry, in English)
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.
- Status (registry)
- Terminated
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 49 (actual)
- First submitted
- 24 Sept 2025
- Start date
- 1 Jan 2026
- Primary completion date
- 31 Aug 2026
- Lead sponsor
- Gadjah Mada University
- NCT number
- NCT07320534
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Death before initiation of chemotherapy.
- Patients with clinically or microbiologically confirmed infection within 72 hours prior to induction chemotherapy who require antibiotics for more than 5 days (to avoid antibiotic therapy as a confounding factor for antibiotic prophylaxis).
Who the study is looking for
- All patients aged 1 to 18 years diagnosed with acute lymphoblastic leukemia (ALL).
- Receiving induction phase 1A chemotherapy for ALL using the Indonesian National Childhood ALL Pilot Protocol 2024 Standard Risk; induction phases 1A and 1B chemotherapy using the Indonesian National Childhood ALL Pilot Protocol 2024 High Risk; or induction chemotherapy using the ACT4ALL Protocol 2025 at Dr. Sardjito Hospital.
- No history of allergy to levofloxacin.
- Parents/guardians provide written informed consent.
Age in the registry: 6 months to 18 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| RSUP dr Sardjito | Sleman | Indonesia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.