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| Name | Class |
|---|---|
| Dr. Sardjito Hospital, Yogyakarta | UNKNOWN |
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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:
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:
Furthermore, this clinical trial aims to:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A: Levofloxacin | Experimental | Receiving oral levofloxacin as infection prophylaxis during the induction phase, with the following dosage:
|
|
| Group B: Placebo | Placebo Comparator | Receiving oral placebo at the same dosage as the treatment group. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Median time to first febrile neutropenia | The number of participants with first febrile neutropenia and the median day of occurrence. | First febrile neutropenia up to day 63 |
| Clinical Outcome | The number of participants who experienced fever, first febrile neutropenia, severe infection, organ-related infection, microbiologically confirmed infection, infection-related mortality | First febrile neutropenia up to day 63 |
| Measure | Description | Time Frame |
|---|---|---|
| Caused of mortality | The cause of mortality in the participants. | up to 12 weeks |
| Patients with positive cultures | The number of participants who were positive for bacteria or fungi, and the number of participants with antibiotic resistance (resistant to fluoroquinolones, carbapenems, or vancomycin). |
| Measure | Description | Time Frame |
|---|---|---|
| Baseline characteristics of the study groups | Number of participants with each variable: Age (only 2 variations)
Sex
Nutritional Status Categories of Children Aged ≤ 10 Years Based on WHO BMI-for-Age Z-scores (BMI in kg/m^2)
BMI Classification for Children Aged > 10 Years Based on BMI (kg/m^2)
Leukemia risk group (only 2 variation, using the Indonesia Pilot Protocol 2024)
|
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| dr. Regina Amanda Putri, M.D | Contact | +6282322335677 | reginamanda11@mail.ugm.ac.id | |
| dr. Idha Yulandari, Sp.A, Fellow | Contact | +6281366659597 | idhayulandari@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Idha Yulandari, M.D. Pediatric | Gadjah Mada University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| RSUP dr Sardjito | Sleman | DI Yogyakarta | Indonesia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30208456 | Result | 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. | |
| 33041718 |
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Inform Consent Form
07 October 2025 for 1,5 years
No data will be shared publicly. Data access will only be provided to qualified researchers upon justified request and with ethics approval.
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| ID | Term |
|---|---|
| D064147 | Febrile Neutropenia |
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| ID | Term |
|---|---|
| D009503 | Neutropenia |
| D000380 | Agranulocytosis |
| D007970 | Leukopenia |
| D000095542 | Cytopenia |
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| ID | Term |
|---|---|
| D064704 | Levofloxacin |
| ID | Term |
|---|---|
| D015242 | Ofloxacin |
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
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| Placebo | Other | Receiving oral placebo at the same dosage as the treatment group. |
|
| up to 12 weeks |
| Day 1 |
| Result |
| 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. |
| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007960 | Leukocyte Disorders |
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D011804 |
| Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |