Ciprofloxacin vs Ceftazidime for Empirical Treatment of High-Risk Neutropenic Fever in Children With Hematologic Malignancies
Launched by GADJAH MADA UNIVERSITY · Jun 10, 2025
Trial Information
Current as of June 26, 2025
Not yet recruiting
Keywords
ClinConnect Summary
This clinical trial is studying which antibiotic works better for treating high-risk fever in children with blood cancers, specifically those with low levels of a type of white blood cell called neutrophils. The two antibiotics being compared are ciprofloxacin and ceftazidime. The goal is to find out if one is more effective as a first-choice treatment and to see if any specific factors influence how well the children respond to either medication.
To participate in this study, children aged 0 to 18 years with certain types of blood cancers and high-risk neutropenic fever can be included. They will be hospitalized at Sardjito General Hospital from June to December 2025. During the trial, children will be randomly assigned to receive either ciprofloxacin or ceftazidime, and the medical team will monitor their health closely. This includes checking how long they have a fever, their hospital stay, and any changes in their treatment. It's important to note that children with certain conditions, allergies to these antibiotics, or other health issues may not be eligible to join the study.
Gender
ALL
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).
About Gadjah Mada University
Gadjah Mada University, a prestigious institution located in Yogyakarta, Indonesia, is recognized for its commitment to advancing research and innovation in various fields, including health sciences. As a clinical trial sponsor, the university leverages its extensive academic expertise and state-of-the-art facilities to conduct rigorous clinical research aimed at enhancing medical knowledge and improving patient outcomes. With a focus on ethical standards and scientific integrity, Gadjah Mada University collaborates with healthcare professionals and researchers to ensure that its clinical trials contribute valuable insights to the medical community and support the development of effective treatments.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Sleman, Di Yogyakarta, Indonesia
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported