Clinical trial NCT07016165: Ciprofloxacin vs Ceftazidime for Empirical Treatment of High-Risk Neutropenic Fever in Children With Hematologic Malignancies
Official title: Ciprofloxacin Versus Ceftazidime as Empirical Therapy of High-Risk Neutropenic Fever in Children With Hematologic Malignancies : A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Neutropenic Fever
Acute Lymphoblastic Leukemia
Acute Myeloblastic Leukemia
Non Hodgkin Lymphoma
Keywords: ciprofloxacin
ceftazidime
neutropenic fever
Acute Lymphoblastic Leukemia
Acute Myeloblastic Leukemia
Non Hodgkin Lymphoma
Lead sponsor: Gadjah Mada University
Sponsor class: OTHER
First posted: 2025-06-11
Enrollment: 120
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This clinical trial will compare use of ciprofloxacin and ceftazidime work in treating high-risk fever in children with hematological malignancies

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.

Detailed description: Furthermore, this clinical trial aims to:

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.

Eligibility criteria: Inclusion Criteria:

* Children aged 0 to 18 years with hematological malignancies.
* 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:

* Children with malignancies but accompanied by comorbidities (HIV infection, septic shock).
* 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).

Primary outcomes:
measure: Duration of fever
timeFrame: from first administration of Ciprofloxacin or Ceftazidime to 48 hours fever free
measure: Duration of Neutropenia
timeFrame: From first antibiotic administration to 48 hours after administration
Secondary outcomes:
measure: Duration of hospitalization
timeFrame: From first administration of Ciprofloxacin or Ceftazidime to hospital discharge
measure: Duration of antibiotic use
timeFrame: days from first administration to the last intravenous antibiotic administration
measure: Antibiotic escalation decisions
timeFrame: From first administration of Ciprofloxacin or Ceftazidime to 48 hours after administration
measure: Mortality
timeFrame: from first administration of ciprofloxacin or ceftazidime to 30 days after recruitment
Other outcomes:
Locations:
city: Sleman
country: Indonesia
facility: RSUP dr Sardjito
state: DI Yogyakarta
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.