A prospective clinical study to evaluate the effect of prophylactic antibiotic use on the occurence of fever in immunocompromised pediatric patients receiving chemotherapy for Acute Myeloid Leukemia in an Indian setting

A prospective randomized controlled study to evaluate the effect of antibiotic prophylaxis on the incidence of febrile neutropenic episodes in pediatric Acute Myeloid Leukemia in an Indian setting - NIL

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/04/085366

Enrollment

110

Registered

2025-04-23

Start date

Unknown

Completion date

Unknown

Last updated

2025-04-28

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

Conditions

Health Condition 1: C920- Acute myeloblastic leukemia

Interventions

Intervention1: Tablet or Syrup Levofloxacin: After taking due consent and assent as required, patients in intervention group will be started on tablet/syrup Levofloxacin as per weight (10mg/kg/dose) o

Eligibility

Inclusion criteria

Inclusion criteria: (1) Patients diagnosed by Flow Cytometry or Immunohistochemistry with AML in the age group of 6 month to 18 years. (2) Patient should be afebrile and not on any antibiotic treatment at the start of cycle.

Exclusion criteria

Exclusion criteria: (1) Patients diagnosed to have Acute Promyelocytic Leukemia. (2) Patients diagnosed to have Mixed Phenotype Acute Leukemia (Myeloid + Lymphoid ) (3) Patients with known immunodeficiency disorder (4) Patients already on antibiotic treatment for fever and/or infection at the start of cycle.

Design outcomes

Primary

Measure	Time frame
Decrease in the incidence of febrile neutropenia (FN) episodes compared to the non-intervention group in patients receiving Levofloxacin as bacterial antibiotic prophylaxis in pediatric Acute Myeloid Leukemia patients undergoing intensive chemotherapy.Timepoint: 12 months	—

Secondary

Measure	Time frame
Decrease in the duration of hospital stay in the intervention group compared to the non-intervention group in pediatric AML patients undergoing intensive chemotherapy.Timepoint: 12 months;Decrease in the use of third line antibiotics in febrile neutropenia (FN) episodes in the intervention group compared to the non-intervention group in pediatric AML patients undergoing intensive chemotherapyTimepoint: 12 months;Decrease in the mortality due to febrile neutropenia (FN) episodes in the intervention group compared to the non-intervention groupin pediatric AML patients undergoing intensive chemotherapyTimepoint: 12 months;Decrease in the incidence of repiratory focus of infection in febrile neutropenia (FN) episodes in the intervention group compared to the non-intervention group in pediatric AML patients undergoing intensive chemotherapy.Timepoint: 12 months	—

Measure

Time frame

Decrease in the duration of hospital stay in the intervention group compared to the non-intervention group in pediatric AML patients undergoing intensive chemotherapy.Timepoint: 12 months;Decrease in the use of third line antibiotics in febrile neutropenia (FN) episodes in the intervention group compared to the non-intervention group in pediatric AML patients undergoing intensive chemotherapyTimepoint: 12 months;Decrease in the mortality due to febrile neutropenia (FN) episodes in the intervention group compared to the non-intervention groupin pediatric AML patients undergoing intensive chemotherapyTimepoint: 12 months;Decrease in the incidence of repiratory focus of infection in febrile neutropenia (FN) episodes in the intervention group compared to the non-intervention group in pediatric AML patients undergoing intensive chemotherapy.Timepoint: 12 months

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Countries

India

Contacts

Public ContactMaharshi Trivedi

Gujarat Cancer and Research Institute

dr.maharshi@yahoo.com9408716111

Outcome results

None listed

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