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A randomized,open labeled,prospective controlled study to assess of frontline empirical intravenous piperacillin/tazobactam monotherapy compared with ceftazidime plus amikacin for pediatric oncology patient with febrile neutropenia

A randomized,open labeled,prospective controlled study to assess of frontline empirical intravenous piperacillin/tazobactam monotherapy compared with ceftazidime plus amikacin for pediatric oncology patient with febrile neutropenia

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
TCTR
Registry ID
TCTR20180205002
Enrollment
118
Registered
2018-02-05
Start date
2017-06-22
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

To determine the efficacy and safety of pipercillin/tazobactam compared with ceftazidime plus amikacin in pediatric oncology patients with febrile neutropenia. pipercillin/tazobactam pediatric febrile neutropenia

Interventions

Febrile neutropenic patients received piperacillin/tazobactam &#44
compared with arm2,Febrile neutropenic patients received ceftazidime plus amikacin &#44
compared with arm 1
Active Comparator Drug,Active Comparator Drug
Piperacillin/Tazobactam,Ceftazidime plus amikacin

Sponsors

Department of pediatrics, Faculty of medicine, Chiang Mai University
Lead Sponsor
Maharaj Nakorn Chiang Mai Hospital
Collaborator

Eligibility

Sex/Gender
All
Age
0 Years to 18 Years

Inclusion criteria

Inclusion criteria: &#45;age < 18 years with diagnosis of malignancies &#45;fever : axillary tenperature 38.3 C or 38.0 C sustained over 1 hour &#45;neutropenia: ANC < 500 cell/mm3 or ANC <1000 cell/mm3 and expected to decrease to < 500 cell/mm3 during next 48 hours

Exclusion criteria

Exclusion criteria: &#45;patients and/or parents decline to participate in this study &#45;systemic intravenous antibiotics pretreatment within 5 days before randomization &#45;history of hypersensitivity to any study drugs &#45;HIV infection &#45;Renal function impairment &#45;Fever due to blood component transfusion

Design outcomes

Primary

MeasureTime frame
Early response to initial antibiotics at the end of treatment complete response to initial antibiotics and resolution of fever within 48 hours—

Secondary

MeasureTime frame
modification therapy at the end of treatment changes of antibiotics,side effects of drugs at the end of treatment records sides effect of drugs,morbidity and mortality at the end of treatment records morbidity and mortality ,costs of treatment at the end of treatment records cost of treatment ,blood stream infection and drug sensitivity at the end of treatment records blood stream infection and drug sensitivity—

Countries

Thailand

Contacts

Public ContactRuchirek Kamolrattana

Faculty of medicine&#44; Chiang Mai University

i_mok910@hotmail.com0873042542

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026