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This clinical trial will compare use of ciprofloxacin and ceftazidime work in treating high-risk fever in children with hematological malignancies
Participants in this study are children with hematological malignancies who have a high risk of fever due to low neutrophil count. Children, aged 0 to 18 years old, will be hospitalized between June and December 2025 at Sardjito General Hospital
The study will involve:
Furthermore, this clinical trial aims to:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Active Comparator | Standard therapy IV ciprofloxacin 10 mg/kgBW/12 hours |
|
| Group B | Experimental | IV ceftazidime 150 mg/kgBW/24 hours divided into 3 doses |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ceftazidime | Drug | Ceftazidime 150 mg/kgBW/24 hours divided into 3 doses. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of fever | Duration of fever since receiving the first antibiotic, based on the temperature graph available in the electronic medical record | from first administration of Ciprofloxacin or Ceftazidime to 48 hours fever free |
| Duration of Neutropenia | The length of time the subject experiences neutropenia, absolute neutrophil count is <500 | From first antibiotic administration to 48 hours after administration |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of hospitalization | The duration from the date of subject recruitment to the date of hospital discharge, as recorded in the electronic medical record. | From first administration of Ciprofloxacin or Ceftazidime to hospital discharge |
| Duration of antibiotic use |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| dr. Khairunisa Rahma Handayani, Medical doctor | Contact | +6281246572652 | khairunisarahma99@mail.ugm.ac.id |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| RSUP dr Sardjito | Recruiting | Sleman | DI Yogyakarta | Indonesia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15770833 | Result | Corapcioglu F, Sarper N. Cefepime versus ceftazidime + amikacin as empirical therapy for febrile neutropenia in children with cancer: a prospective randomized trial of the treatment efficacy and cost. Pediatr Hematol Oncol. 2005 Jan-Feb;22(1):59-70. doi: 10.1080/08880010590896297. | |
| 31554370 | Result | Kamonrattana R, Sathitsamitphong L, Choeyprasert W, Charoenkwan P, Natesirinilkul R, Fanhchaksai K. A Randomized, Open-Labeled, Prospective Controlled Study to Assess the Efficacy of Frontline Empirical Intravenous Piperacillin/Tazobactam Monotherapy in Comparison with Ceftazidime Plus Amikacin for Febrile Neutropenia in Pediatric Oncology Patients. Asian Pac J Cancer Prev. 2019 Sep 1;20(9):2733-2737. doi: 10.31557/APJCP.2019.20.9.2733. |
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Data sharing will be considered after completion of ongoing analyses
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| Ciprofloxacin |
| Drug |
Ciprofloxacin 10 mg/kgBW/12 hours |
|
days of antibiotic use from the first administration to the last intravenous antibiotic administration |
| days from first administration to the last intravenous antibiotic administration |
| Antibiotic escalation decisions | Clinician decisions in escalating empirical antibiotics to second-line antibiotics | From first administration of Ciprofloxacin or Ceftazidime to 48 hours after administration |
| Mortality | Mortality of subject in admission is proven by a death certificate | from first administration of ciprofloxacin or ceftazidime to 30 days after recruitment |
| 23317527 | Result | Yasuda T, Suzuki R, Ishikawa Y, Terakura S, Inamoto Y, Yanada M, Nagai H, Ozawa Y, Ozeki K, Atsuta Y, Emi N, Naoe T. Randomized controlled trial comparing ciprofloxacin and cefepime in febrile neutropenic patients with hematological malignancies. Int J Infect Dis. 2013 Jun;17(6):e385-90. doi: 10.1016/j.ijid.2012.12.005. Epub 2013 Jan 11. |
| ID | Term |
|---|---|
| D064147 | Febrile Neutropenia |
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| D015470 | Leukemia, Myeloid, Acute |
| D008228 | Lymphoma, Non-Hodgkin |
| ID | Term |
|---|---|
| D009503 | Neutropenia |
| D000380 | Agranulocytosis |
| D007970 | Leukopenia |
| D000095542 | Cytopenia |
| 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 |
| D007951 | Leukemia, Myeloid |
| D008223 | Lymphoma |
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| ID | Term |
|---|---|
| D002442 | Ceftazidime |
| D002939 | Ciprofloxacin |
| ID | Term |
|---|---|
| D002509 | Cephaloridine |
| D002511 | Cephalosporins |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013843 | Thiazines |
| D013457 | Sulfur Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
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