A clinical study with random allocation of young cancer patients having fever with low neutrophil blood count for comparing the safety and cost-effectiveness of early stoppage of antibiotic without neutrophil count recovery versus with neutrophil count recovery in these patients

Not Applicable

• Conditions: Health Condition 1: null- High Risk Febrile Neutropenia pediatric cancer patients

• Registration Number: CTRI/2016/02/006618
• Lead Sponsor: Dr Brijesh Arora

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 100

Inclusion Criteria

(1)Subjects with ages 2 to 24 years

(2)Receiving chemotherapy for a) newly diagnosed, relapsed or secondary AML; b) newly diagnosed ALL in induction or delayed intensification c) relapsed ALL in induction, consolidation, or intensification; d) advanced stage Burkitt lymphoma in induction or consolidation of LMB protocol.

(3)Febrile neutropenia defined as fever (temperature ï?³ 38ï?°C on two occasions within a 12 hour period or ï?³ 38.3ï?°C once) during neutropenia (absolute neutrophil count < 500 x 109 cells/L or absolute neutrophil count <1000 x 109 cells/L and falling) at least once during the 7 days prior to enrollment.

(4)At days 3-5, (A) meet criteria for antibiotic cessation consisting of: a) absence of fever (38.0° C) for at least 24 hours; (b) absence of a clinically or microbiologically documented infection for which antibiotic treatment after day 5 of febrile neutropenia would be required; and (c) absence of major co-morbidity such as severe grade 3 or greater (via CTCAE version 4.0) severe mucositis or abdominal pain, vomiting, hypotension, respiratory distress, or neurological signs or symptoms and (B) remain neutropenic with an absolute neutrophil count < 100 x 109 cells/L.

Exclusion Criteria

(1)Previous enrollment on the trial

(2)Renal insufficiency on day 1 of febrile neutropenia defined via a calculated creatinine clearance < 70mL/min/1.73m2 or a higher than normal serum creatinine based on age/gender.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To assess the reduction in antibiotic use by comparing the duration of intravenous antibiotics in 2 armsTimepoint: During inpatient admission for incidences of febrile neutropenia

Secondary Outcome Measures

Name	Time	Method
To describe the differences between the two groups of patients in the following outcome measures of interest: <br/ ><br>1.Proportion with successful episodes <br/ ><br>2.Proportion with morbidity <br/ ><br>3.Proportion with complications <br/ ><br>4.Cost of care <br/ ><br>5.Febrile neutropenia related mortality <br/ ><br>6.Proportion with nephrotoxicity <br/ ><br>7.Proportion with a delay in chemotherapy secondary to infection or neutropeniaTimepoint: During inpatient admission for incidences of febrile neutropenia