Neutropenic FeverPhase 4NCT07016165
Ciprofloxacin vs Ceftazidime for Empirical Treatment of High-Risk Neutropenic Fever in Children With Hematologic Malignancies
A Phase 4 study testing Ceftazidime and Ciprofloxacin in people with Neutropenic Fever and Acute Lymphoblastic Leukemia, run by Gadjah Mada University at 1 site in Indonesia.
Trial 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… Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Neutropenic Fever, Acute Lymphoblastic Leukemia, Acute Myeloblastic Leukemia
- What is being tested?
- Ceftazidime and Ciprofloxacin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Jun 2025to 31 Dec 2025
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
dr. Khairunisa Rahma Handayani, Medical doctor contact
Indonesia1 site, 1 recruiting
- Recruiting
RSUP dr Sardjito
Sleman, DI Yogyakarta
dr. Amanda Sari Puspita, Pediatric resident, +62 821-8300-4177, amanda.sari.p@mail.ugm.ac.id
About this study
Official title: Ciprofloxacin Versus Ceftazidime as Empirical Therapy of High-Risk Neutropenic Fever in Children With Hematologic Malignancies : A Randomized Controlled Trial
This clinical trial will compare use of ciprofloxacin and ceftazidime work in treating high-risk fever in children with hematological malignancies
- 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?
- Are there any specific factors that affect how children with hematological malignancies respond to ciprofloxacin or ceftazidime when treating high-risk fever?
Read more
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.
Read the detailed description
Furthermore, this clinical trial aims to:
- Compare the efficacy of empirical antibiotic administration of Ciprofloxacin and Ceftazidime in pediatric malignancy patients with high-risk neutropenic fever.
- 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.
- Compare the mortality of pediatric patients with high-risk neutropenic fever due to hematological malignancies who received empirical antibiotic therapy of ceftazidime and ciprofloxacin.
- 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
- Neutropenic Fever, Acute Lymphoblastic Leukemia, Acute Myeloblastic Leukemia, Non Hodgkin Lymphoma
- Being tested
- Ceftazidime, Ciprofloxacin
- Keywords
- ciprofloxacin, ceftazidime, neutropenic fever, Acute Lymphoblastic Leukemia, Acute Myeloblastic Leukemia, Non Hodgkin Lymphoma
- Medical subject headings
- Febrile Neutropenia, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Leukemia, Myeloid, Acute, Lymphoma, Non-Hodgkin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CeftazidimeDrug
Ceftazidime 150 mg/kgBW/24 hours divided into 3 doses.
CiprofloxacinDrug
Ciprofloxacin 10 mg/kgBW/12 hours
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | Standard therapy IV ciprofloxacin 10 mg/kgBW/12 hours Receives: Drug: Ciprofloxacin |
| Group B | Experimental | IV ceftazidime 150 mg/kgBW/24 hours divided into 3 doses Receives: Drug: Ceftazidime |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of fever
Duration of fever since receiving the first antibiotic, based on the temperature graph available in the electronic medical record
Measured: from first administration of Ciprofloxacin or Ceftazidime to 48 hours fever free
Duration of Neutropenia
The length of time the subject experiences neutropenia, absolute neutrophil count is <500
Measured: From first antibiotic administration to 48 hours after administration
Secondary outcomes (4)
Duration of hospitalization
The duration from the date of subject recruitment to the date of hospital discharge, as recorded in the electronic medical record.
Measured: From first administration of Ciprofloxacin or Ceftazidime to hospital discharge
Duration of antibiotic use
days of antibiotic use from the first administration to the last intravenous antibiotic administration
Measured: days from first administration to the last intravenous antibiotic administration
Antibiotic escalation decisions
Clinician decisions in escalating empirical antibiotics to second-line antibiotics
Measured: From first administration of Ciprofloxacin or Ceftazidime to 48 hours after administration
Mortality
Mortality of subject in admission is proven by a death certificate
Measured: from first administration of ciprofloxacin or ceftazidime to 30 days after recruitment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2025
- Study start1 Jun 2025
- Primary completion30 Nov 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Neutropenic FeverStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gadjah Mada University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bambang Ardianto, Gadjah Mada University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07016165
- Sponsor's protocol ID
- KE/FK/0517/EC/2025
- Status last verified
- Jun 2025
- First submitted
- 30 May 2025
- Last updated
- 22 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data sharing will be considered after completion of ongoing analyses
Publications
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.
PubMed 15770833Kamonrattana 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.
PubMed 31554370Yasuda 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.
PubMed 23317527