A multicenter, randomized, controlled trial comparing the efficacy of oral fluoroquinolone and aminopenicillin with intravenous Cephalosporin in low-risk pediatric cancer patients with febrile neutropenia.

A multicenter, randomized, controlled trial comparing the efficacy of oral fluoroquinolone and aminopenicillin with intravenous Cephalosporin in low-risk pediatric cancer patients with febrile neutropenia. - Oral fluoriquinolones and aminopenicillins versus intravenous Cephalosporin in low-risk pediatric cancer patients with febrile neutropenia.

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000006131

Enrollment

124

Registered

2011-08-08

Start date

2010-09-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Childhood cancer

Interventions

Tosufloxacin + Amoxicillin/clavulanate (oral) Cefepime (intravenous)

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)Patients diagnosed as pediatric cancer with age 1 to 19 years 2)Febrile (1 episode of axillary temperature above 38.3 degrees or 2 episodes of 38 degrees taken on two occasions at least 1 hour apart within the last 24 hours ) 3) Absolute neutrophil count (ANC) less than 1000/microliter (band cell + segmented cell) in peripheral blood sample within 3 days including the day of developing fever 4)Informed consent is taken by substitute and the patient over 16 years old in writing

Exclusion criteria

Exclusion criteria: 1) patients who has a history of stem cell transplantation 2) acute leukemia or lymphoma patients who are under induction or consolidation chemotherapy 3) patients with suspected central venous catheter-related infection 4) patients with consciousness disturbance (under 15 points of pediatric Glasgow coma scale) 5) patients with hypotension 6) patients with hypoxemia (SpO2 less than 95% by pulse oximeter under the room air) 7) patients with apparent active infection 8) patients with nausea and vomiting expected difficult to take internal medicine 9) patients of organ failure (Grade3 or 4 level in NCI CTCAE, such as Hyperbilirubinemia,elevated alanine aminotransferase,elevated aspartate aminotransferase,elevated serum creatinine) 10) patients administrated other antibiotics (except sulfamethoxazole/trimethoprim as prophylaxis against pneumocystis carinii) 11) patients with hypersensitivity against Tosufloxacin, Amoxicillin/clavulanate,and cefepime 12) pregnant patients or those who are suspected pregnancy 13) patients who are considered inappropriate to join this study by the physicians

Design outcomes

Primary

Measure	Time frame
Treatment success rate defined as resolution rate of febrile neutropenia without change of treatment regimen	—

Secondary

Measure	Time frame
Duration of fever, Positive rates of blood cultures, Rates of adverse events, Rates of recurrence of fever	—

Countries

Japan

Contacts

Public ContactNaoko Tsuji

Tokyo Metropolitan Children's Medical Center Department of Hematology and Oncology

042-300-5111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026