Levofloxacin Prophylaxis to Prevent First Febrile Neutropenia in Pediatric ALL During Induction Phase
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Levofloxacin, Placebo.
- Who it may be relevant to
- Registry conditions: Neutropenic Fever, Acute Lymphoblastic Leukemia. Basic parameters: 6 months — 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Indonesia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
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.
Detailed description
Furthermore, this clinical trial aims to:
* To determine the incidence of fever during the induction phase in pediatric ALL patients receiving levofloxacin prophylaxis compared with placebo. * To determine the incidence of febrile neutropenia during the induction phase in pediatric ALL patients receiving levofloxacin prophylaxis compared with placebo. * To determine the incidence of severe infections during the induction phase in pediatric ALL patients receiving levofloxacin prophylaxis compared with placebo. * To determine the number of organ-related bacterial infections, whether microbiologically confirmed or not, during the induction phase in pediatric ALL patients receiving levofloxacin prophylaxis compared with placebo. * To determine the mortality rate during the induction phase in pediatric ALL patients receiving levofloxacin prophylaxis compared with placebo.
Interventions
- Drug Levofloxacin
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) - Other Placebo
Receiving oral placebo at the same dosage as the treatment group.
Primary outcome measures
- Median time to first febrile neutropenia [Time frame: First febrile neutropenia up to day 63]
- Clinical Outcome [Time frame: First febrile neutropenia up to day 63]
Secondary outcome measures (2)
- Caused of mortality [Time frame: up to 12 weeks]
- Patients with positive cultures [Time frame: up to 12 weeks]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
Indonesia · 1 center
- RSUP dr Sardjito — Sleman
Publications
- Alexander S, Fisher BT, Gaur AH, Dvorak CC, Villa Luna D, Dang H, Chen L, Green M, Nieder ML, Fisher B, Bailey LC, Wiernikowski J, Sung L; Children's Oncology Group. Effect of Levofloxacin Prophylaxis on Bacteremia in Children With Acute Leukemia or Undergoing Hematopoietic Stem Cell Transplantation: A Randomized Clinical Trial. JAMA. 2018 Sep 11;320(10):995-1004. doi: 10.1001/jama.2018.12512. PMID 30208456
- Patel B, Noda A, Godbout E, Stevens M, Noda C. Levofloxacin for Antibacterial Prophylaxis in Pediatric Patients With Acute Myeloid Leukemia or Undergoing Hematopoietic Stem Cell Transplantation. J Pediatr Pharmacol Ther. 2020;25(7):629-635. doi: 10.5863/1551-6776-25.7.629. PMID 33041718
Identifiers
NCT: NCT07320534 · KE/FK/1504/EC/2025