Ciprofloxacin versus ceftazidime for high-risk neutropenic fever in children with blood cancers

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Cord blood transplant for children and young adults with blood cancers.

  This study will test whether a cord blood transplant given as a first or second transplant can help children and young adults with leukemia, myelodysplasia, or lymphoma who lack a matched donor.

  Recruiting Phase 2 Memorial Sloan Kettering Cancer Center · New York, New York · NCT07566377

• LV009 injection for relapsed or refractory CD19-positive blood and lymph cancers

  This will test whether LV009 injections are safe for adults with relapsed or refractory CD19-positive non-Hodgkin lymphoma or acute lymphoblastic leukemia.

  Recruiting Phase 1 PersonGen BioTherapeutics (Suzhou) Co., Ltd. · Suzhou, Jiangsu · NCT07284927

• CMV Triplex vaccine to boost immunity and prevent CMV after haploidentical stem cell transplant

  This trial tests whether giving a CMV-MVA Triplex vaccine to donors and/or recipients, with or without the antiviral letermovir, can boost CMV immunity and prevent CMV viremia in people having haploidentical stem cell transplants.

  Recruiting at 3 sites Phase 1 City of Hope Medical Center · Duarte, California and 2 other locations · NCT07020533

• Vitamin A and D supplementation for patients undergoing allogeneic hematopoietic transplantation

  This study is testing if giving high doses of vitamins A and D before a stem cell transplant can help patients with certain blood cancers have fewer complications like infections and graft-versus-host disease.

  Recruiting Phase 2 St. Petersburg State Pavlov Medical University · Saint Petersburg · NCT06508099

• Using post-transplant cyclophosphamide and ATG for blood cancer transplants

  This study is testing whether using post-transplant cyclophosphamide and ATG can help prevent graft-versus-host disease in patients with blood cancers who are getting stem cell transplants.

  Recruiting Phase 1/2 Instituto Nacional de Cancer, Brazil · Rio de Janeiro, Rio de Janeiro · NCT06299462

• Vaccination to prevent CMV infection in stem cell transplant patients

  This study is testing a new vaccine to see if it can help prevent CMV infections in patients receiving stem cell transplants from related donors.

  Recruiting at 3 sites Phase 2 City of Hope Medical Center · Duarte, California and 2 other locations · NCT06059391

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.