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Stoppage of antibiotics at clinical improvement in pediatric cancer patients with high risk febrile neutropenia â?? A randomized clinical study

Phase 3
Conditions
Health Condition 1: C959- Leukemia, unspecified
Registration Number
CTRI/2018/10/015994
Lead Sponsor
Department Of Medical Oncology Aiims
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Open to Recruitment
Sex
Not specified
Target Recruitment
0
Inclusion Criteria

1. Age 2-18 years

2.AML and ALL Induction and re-induction with febrile neutropenia

3.Blood culture taken prior or within 24 hrs of start of anti-microbial therapy

4.Giving consent

Exclusion Criteria

1.Already enrolled once in previous episode

2.Retroviral positive patients

3.Patients who required therapeutic anti-fungals during febrile neutropenia

4.Patients who required more than first line(cefoperazone-sulbactam+amikacin, levofloxacin or any oral antibiotics) and second line antibiotics(cefoperazone-sulbactam+meropenem/imipenem+teicoplanin/clindamycin)

5.Patients who required inotropic support/mechanical ventilation during treatment course for febrile neutropenia

6.Severe renal function impairment (defined as creatinine clearance below 30 ml/ min)

7.Clinical or microbiological or radiologic focus of infection

8.Patient undergone stem cell transplant

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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