A study on comparison between monetary & clinical benefit gained by stopping antibiotic therapy early in high risk type of fever with blood neutrophil count less than 500 per micro litre in children with cancer

Cost-effectiveness of early stoppage of empirical antibiotic therapy at clinical improvement in pediatric cancer patients with high risk febrile neutropenia nested within an ongoing open label randomized control trial

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2020/07/026858

Enrollment

120

Registered

2020-07-28

Start date

Unknown

Completion date

Unknown

Last updated

2022-11-21

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

Conditions

Health Condition 1: D701- Agranulocytosis secondary to cancer chemotherapy

Interventions

Intervention1: Stoppage of empirical antibiotic therapy at clinical recovery of high risk febrile neutropenia: In pediatric cancer patients with high risk febrile neutropenia who are satisfying inclu

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age 2-18 yrs 2. De novo and relapsed AML & ALL undergoing induction & reinduction with febrile neutropenia

Exclusion criteria

Exclusion criteria: 1. Already enrolled once in previous episode 2. Retrovirus positive patients 3. Patients who require >= 3rd line antibiotics during febrile neutropenia episode prior to becoming afebrile 4. Patients who require therapeutic antifungals during febrile neutropenia episode prior to enrolment 5. Patients who require ionotropic support / mechanical ventilation during treatment course for febrile neutropenia episode prior to enrolment 6. Severe renal function impairment (defined as a creatinine clearance below 30 ml/min) during treatment course for febrile neutropenia prior to enrolment 7. The clinical or microbiological or radiologic focus of infection during treatment course for febrile neutropenia prior to enrolment 8. Patient undergone stem cell transplant 9. Denying consent

Design outcomes

Primary

Measure	Time frame
Cost-effectiveness of early stoppage of EAT in high risk febrile neutropenia pediatric patients w.r.t antibiotic free daysTimepoint: day of randomization to the day of exit from the study (day when absolute neutrophil count becomes more than 500 per micro litre or day 35 of from beginning of induction chemotherapy whichever is earlier)	—

Secondary

Measure	Time frame
1. Cost-effectiveness analysis w.r.t recurrent fever, total days of antibiotic use, third line antibiotic use, therapeutic anti-fungal use, number of days of hospitalization, mechanical ventilation and inotropes use, and mortality in each arm 2. Cost-benefit analysis w.r.t above clinical parameters 3. Cost-utility analysis w.r.t Quality of life scores in either armTimepoint: day of randomization day of exit from study	—

Measure

Time frame

1. Cost-effectiveness analysis w.r.t recurrent fever, total days of antibiotic use, third line antibiotic use, therapeutic anti-fungal use, number of days of hospitalization, mechanical ventilation and inotropes use, and mortality in each arm 2. Cost-benefit analysis w.r.t above clinical parameters 3. Cost-utility analysis w.r.t Quality of life scores in either armTimepoint: day of randomization day of exit from study

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Countries

India

Contacts

Public ContactRUPAK KUMAR GIRI

AIIMS, NewDelhi

sambakh@hotmail.com011-29575237

Outcome results

None listed

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