Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-31 @ 12:47 PM
Study NCT ID:
NCT07320534
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-01-08
First Post:
2025-09-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Levofloxacin Prophylaxis to Prevent First Febrile Neutropenia in Pediatric ALL During Induction Phase
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D064147', 'term': 'Febrile Neutropenia'}, {'id': 'D054198', 'term': 'Precursor Cell Lymphoblastic Leukemia-Lymphoma'}], 'ancestors': [{'id': 'D009503', 'term': 'Neutropenia'}, {'id': 'D000380', 'term': 'Agranulocytosis'}, {'id': 'D007970', 'term': 'Leukopenia'}, {'id': 'D000095542', 'term': 'Cytopenia'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007960', 'term': 'Leukocyte Disorders'}, {'id': 'D007945', 'term': 'Leukemia, Lymphoid'}, {'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D064704', 'term': 'Levofloxacin'}], 'ancestors': [{'id': 'D015242', 'term': 'Ofloxacin'}, {'id': 'D024841', 'term': 'Fluoroquinolones'}, {'id': 'D042462', 'term': '4-Quinolones'}, {'id': 'D015363', 'term': 'Quinolones'}, {'id': 'D011804', 'term': 'Quinolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 124}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-01-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2026-08-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-01-06', 'studyFirstSubmitDate': '2025-09-24', 'studyFirstSubmitQcDate': '2025-12-25', 'lastUpdatePostDateStruct': {'date': '2026-01-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-07-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Baseline characteristics of the study groups', 'timeFrame': 'Day 1', 'description': 'Number of participants with each variable:\n\nAge (only 2 variations)\n\n* \\<10 years\n* ≥10 years\n\nSex\n\n* Male\n* Female\n\nNutritional Status Categories of Children Aged ≤ 10 Years Based on WHO BMI-for-Age Z-scores (BMI in kg/m\\^2)\n\n* Severely wasted\n* Wasted\n* Normal\n* Possible risk of overweight\n* Overweight\n* Obese\n\nBMI Classification for Children Aged \\> 10 Years Based on BMI (kg/m\\^2)\n\n* Underweight\n* Normal\n* Overweight\n* Obesity\n\nLeukemia risk group (only 2 variation, using the Indonesia Pilot Protocol 2024)\n\n* Standard risk\n* High risk'}], 'primaryOutcomes': [{'measure': 'Median time to first febrile neutropenia', 'timeFrame': 'First febrile neutropenia up to day 63', 'description': 'The number of participants with first febrile neutropenia and the median day of occurrence.'}, {'measure': 'Clinical Outcome', 'timeFrame': 'First febrile neutropenia up to day 63', 'description': 'The number of participants who experienced fever, first febrile neutropenia, severe infection, organ-related infection, microbiologically confirmed infection, infection-related mortality'}], 'secondaryOutcomes': [{'measure': 'Caused of mortality', 'timeFrame': 'up to 12 weeks', 'description': 'The cause of mortality in the participants.'}, {'measure': 'Patients with positive cultures', 'timeFrame': 'up to 12 weeks', 'description': '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).'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Neutropenic Fever', 'Acute Lymphoblastic Leukemia', 'Levofloxacin'], 'conditions': ['Neutropenic Fever', 'Acute Lymphoblastic Leukemia']}, 'referencesModule': {'references': [{'pmid': '30208456', 'type': 'RESULT', 'citation': "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': '33041718', 'type': 'RESULT', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nThe main questions it aims to answer are:\n\n* Does levofloxacin prophylaxis increase the median time to the first febrile neutropenia episode compared to placebo?\n* What are the rates of fever, severe infection, organ-related bacterial infection, and mortality in children receiving levofloxacin compared to placebo?\n\nResearchers 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.\n\nParticipants will:\n\n* Be children aged 1 to 18 years with ALL undergoing induction chemotherapy.\n* Be randomly assigned to receive either levofloxacin prophylaxis or placebo during the induction phase.\n* Have regular checkups, physical exams, and laboratory tests during induction.\n* Be monitored for fever, febrile neutropenia, severe infections, bacterial infections, and mortality.\n* Stop prophylaxis once the first febrile neutropenia occurs or induction therapy is completed.', 'detailedDescription': 'Furthermore, this clinical trial aims to:\n\n* To determine the incidence of fever during the induction phase in pediatric ALL patients receiving levofloxacin prophylaxis compared with placebo.\n* To determine the incidence of febrile neutropenia during the induction phase in pediatric ALL patients receiving levofloxacin prophylaxis compared with placebo.\n* To determine the incidence of severe infections during the induction phase in pediatric ALL patients receiving levofloxacin prophylaxis compared with placebo.\n* 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.\n* To determine the mortality rate during the induction phase in pediatric ALL patients receiving levofloxacin prophylaxis compared with placebo.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '6 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients aged 1 to 18 years diagnosed with acute lymphoblastic leukemia (ALL).\n* 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.\n* No history of allergy to levofloxacin.\n* Parents/guardians provide written informed consent.\n\nExclusion Criteria:\n\n* Death before initiation of chemotherapy.\n* 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).'}, 'identificationModule': {'nctId': 'NCT07320534', 'briefTitle': 'Levofloxacin Prophylaxis to Prevent First Febrile Neutropenia in Pediatric ALL During Induction Phase', 'organization': {'class': 'OTHER', 'fullName': 'Gadjah Mada University'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'KE/FK/1504/EC/2025'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group A: Levofloxacin', 'description': 'Receiving oral levofloxacin as infection prophylaxis during the induction phase, with the following dosage:\n\n* Age \\< 5 years: 10 mg/kg PO every 12 hours (maximum 250 mg/dose)\n* Age ≥ 5 years: 10 mg/kg PO once daily (maximum 500 mg/day)', 'interventionNames': ['Drug: Levofloxacin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Group B: Placebo', 'description': 'Receiving oral placebo at the same dosage as the treatment group.', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Levofloxacin', 'type': 'DRUG', 'description': '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)', 'armGroupLabels': ['Group A: Levofloxacin']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Receiving oral placebo at the same dosage as the treatment group.', 'armGroupLabels': ['Group B: Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Sleman', 'state': 'DI Yogyakarta', 'country': 'Indonesia', 'contacts': [{'name': 'dr. Idha Yulandari, Sp.A, Fellow', 'role': 'CONTACT', 'email': 'idhayulandari@gmail.com', 'phone': '+62 813-6665-9597'}], 'facility': 'RSUP dr Sardjito', 'geoPoint': {'lat': -7.71556, 'lon': 110.35556}}], 'centralContacts': [{'name': 'dr. Regina Amanda Putri, M.D', 'role': 'CONTACT', 'email': 'reginamanda11@mail.ugm.ac.id', 'phone': '+6282322335677'}, {'name': 'dr. Idha Yulandari, Sp.A, Fellow', 'role': 'CONTACT', 'email': 'idhayulandari@gmail.com', 'phone': '+6281366659597'}], 'overallOfficials': [{'name': 'Idha Yulandari, M.D. Pediatric', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Gadjah Mada University'}]}, 'ipdSharingStatementModule': {'url': 'https://drive.google.com/file/d/1BGYHRI1fgXd5k7X0VABCEte6_RG_YB_O/view?usp=drive_link', 'infoTypes': ['ICF'], 'timeFrame': '07 October 2025 for 1,5 years', 'ipdSharing': 'YES', 'description': 'Inform Consent Form', 'accessCriteria': 'No data will be shared publicly. Data access will only be provided to qualified researchers upon justified request and with ethics approval.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gadjah Mada University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Dr. Sardjito Hospital, Yogyakarta', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Idha Yulandari', 'investigatorAffiliation': 'Gadjah Mada University'}}}}