Oral Cefixime vs Intravenous Piperacillin/Tazobactam and Amikacin in Children with Low Risk Febrile Neutropenia

Oral Cefixime vs Intravenous Piperacillin/Tazobactam and Amikacin in Children with Low Risk Febrile Neutropenia- An Open Label Non Inferiority Randomized Control Trial - NIL

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/12/060806

Enrollment

200

Registered

2023-12-27

Start date

Unknown

Completion date

Unknown

Last updated

2024-01-22

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

Conditions

Health Condition 1: D703- Neutropenia due to infection

Interventions

Intervention1: Oral Cefixime Suspension: 8mg/kg/day in two divided doses Control Intervention1: Injection Piperacillin/Tazobactam and Injection Amikacin: Piperacillin/Tazobactam- 100mg/kg intravenous,

Eligibility

Inclusion criteria

Inclusion criteria: Those fulfilling the criteria for Low-risk Febrile Neutropenia (defined as minimally myelosuppressive chemotherapy, briefly myelosuppressive chemotherapy ,no clinical focus of infection ,no organ dysfunction , no hemodynamic instability, oral mucositis <grade 3, no profound neutropenia)

Exclusion criteria

Exclusion criteria: Those who did not consent for oral antibiotics and those who have received oral or intravenous antibiotics in the past 7 days.

Design outcomes

Primary

Measure	Time frame
To determine treatment success rate of oral Cefixime as compared to Intravenous Piperacillin/Tazobactam and Amikacin in low risk febrile neutropenia in pediatric patients (1 year to 15 years) receiving chemotherapyTimepoint: 2 weeks	—

Secondary

Measure	Time frame
To compare all cause mortality till Day 14 of start of antibiotics in both the armsTimepoint: 14 days of enrolment;To determine the median duration of the neutropeniaTimepoint: Till Absolute Neutrophil Count more than 500/mm3;To study the adverse effects of oral cefixime and Intravenous Piperacillin/Tazobactam and Amikacin using CTCAE criteriaTimepoint: Till treatment completion	—

Countries

India

Contacts

Public ContactSatyendra Batra

All India Institute of Medical Sciences, New Delhi

drrachnaseth1967@gmail.com9650210242

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026