Ciprofloxacin versus ceftazidime for high-risk neutropenic fever in children with blood cancers
Ciprofloxacin Versus Ceftazidime as Empirical Therapy of High-Risk Neutropenic Fever in Children With Hematologic Malignancies : A Randomized Controlled Trial
We will test whether ceftazidime or ciprofloxacin works better as the first antibiotic for children (0–18) with blood cancers who develop high-risk fever from low neutrophil counts.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | N/A to 18 Years |
| Sex | All |
| Sponsor | Gadjah Mada University Academic / other |
| Locations | 1 site (Sleman, DI Yogyakarta) |
| Trial ID | NCT07016165 on ClinicalTrials.gov |
What this trial studies
Hospitalized children aged 0–18 with hematologic malignancies and high-risk neutropenic fever will be randomly assigned to receive intravenous ciprofloxacin or intravenous ceftazidime. Investigators will collect history, perform physical exams and supporting laboratory tests, and follow patients for outcomes including duration of fever, duration of neutropenia, length of hospital stay, need for antibiotic escalation, and mortality. Participants will be enrolled at RSUP dr Sardjito (Sleman, DI Yogyakarta) between June and December 2025 under parental consent. Standard exclusion criteria include major comorbidities (e.g., HIV, septic shock), recent other antibiotics within 72 hours, significant renal or liver impairment, or allergy to either drug.
Who should consider this trial
Good fit: Children 0–18 years old with hematologic malignancies who are hospitalized with high-risk neutropenic fever and whose parents provide consent are the intended participants.
Not a fit: Children with major comorbidities (such as HIV or septic shock), recent nonallowed antibiotic exposure, significant renal or liver dysfunction, or allergy to ciprofloxacin or ceftazidime are unlikely to benefit from enrollment.
Why it matters
Potential benefit: If successful, the trial could identify which antibiotic leads to faster recovery, fewer escalations, and lower complications for children with high-risk neutropenic fever.
How similar studies have performed: Both ciprofloxacin and ceftazidime have been used for neutropenic fever in adults and children, but direct randomized comparisons specifically in pediatric hematologic malignancy patients are limited.
Eligibility criteria
Show full inclusion / exclusion 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).
Where this trial is running
Sleman, DI Yogyakarta
- RSUP dr Sardjito — Sleman, DI Yogyakarta, Indonesia (Recruiting)
Study contacts
- Study coordinator: dr. Khairunisa Rahma Handayani, Medical doctor
- Email: khairunisarahma99@mail.ugm.ac.id
- Phone: +6281246572652
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.