Ciprofloxacin vs Ceftazidime for Empirical Treatment of High-Risk Neutropenic Fever in Children With Hematologic Malignancies
NCT ID: NCT07016165
Last Updated: 2025-08-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
120 participants
INTERVENTIONAL
2025-06-01
2025-12-31
Brief Summary
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1. Does ceftazidime work better than ciprofloxacin as a first-choice antibiotic for children with hematological malignancies who have high-risk fever from low neutrophil count?
2. Are there any specific factors that affect how children with hematological malignancies respond to ciprofloxacin or ceftazidime when treating high-risk fever?
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:
* Collecting patient history, conducting physical exams, and performing supporting tests.
* Randomly assigning participants into two groups: one group will receive the standard treatment with intravenous ciprofloxacin, while the other group will receive the intervention treatment with intravenous ceftazidime.
* Both groups will be monitored for various outcomes, including the length of fever, length of low white blood cell count, length of hospital stay, length of antibiotic use, any changes in antibiotics, and mortality.
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Detailed Description
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1. Compare the efficacy of empirical antibiotic administration of Ciprofloxacin and Ceftazidime in pediatric malignancy patients with high-risk neutropenic fever.
2. Analyze the differences in clinical effectiveness between ceftazidime and ciprofloxacin antibiotics based on the duration of fever, duration of neutropenia, duration of hospitalization in high-risk neutropenic fever in children with hematological malignancies.
3. Compare the mortality of pediatric patients with high-risk neutropenic fever due to hematological malignancies who received empirical antibiotic therapy of ceftazidime and ciprofloxacin.
4. Compare antibiotic escalation decisions in pediatric patients with high-risk neutropenic fever due to hematological malignancies who received empirical antibiotic therapy of ceftazidime and ciprofloxacin.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Group A
Standard therapy IV ciprofloxacin 10 mg/kgBW/12 hours
Ciprofloxacin
Ciprofloxacin 10 mg/kgBW/12 hours
Group B
IV ceftazidime 150 mg/kgBW/24 hours divided into 3 doses
Ceftazidime
Ceftazidime 150 mg/kgBW/24 hours divided into 3 doses.
Interventions
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Ceftazidime
Ceftazidime 150 mg/kgBW/24 hours divided into 3 doses.
Ciprofloxacin
Ciprofloxacin 10 mg/kgBW/12 hours
Eligibility Criteria
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Inclusion Criteria
* Children with high-risk neutropenic fever, namely children with blood malignancies induction phase ALL, consolidation phase ALL, reinduction phase ALL, relapse ALL; meningeal ALL, AML, and NHL, diagnosed by a competent pediatrician on duty.
* Consent from parents to be included in the study.
Exclusion Criteria
* Allergy to ciproloxacin or ceftazidime.
* Fever associated with blood transfusion reactions.
* Receiving other antibiotics since 72 hours before being included in the study, except for cotrimoxazole prophylaxis for the prevention of Pneumocystis carinii pneumonia, and ciproloxacin prophylaxis in AML.
* Children with blood malignancies who have impaired renal function (serum creatinine ≥ 1.5 times the upper normal limit) and impaired liver function (SGPT \> 5 times the upper normal limit).
18 Years
ALL
No
Sponsors
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Gadjah Mada University
OTHER
Responsible Party
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Bambang Ardianto
Principal Investigator, Head of Pediatric Hematolo-Oncology Divison
Locations
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RSUP dr Sardjito
Sleman, DI Yogyakarta, Indonesia
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
Other Identifiers
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KE/FK/0517/EC/2025
Identifier Type: -
Identifier Source: org_study_id
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