Safety of Procalcitonin Guided Discontinuation of Antibiotic Therapy among Children Receiving Cancer Chemotherapy and Having Low Risk Febrile Neutropenia â?? A Randomized Non-Inferiority Trial - ProFenC Study

AIIMS0 个研究点目标入组 0 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•Children aged <=18 years diagnosed with cancer receiving cancer chemotherapy (received at least one cycle of chemotherapy)
•1.Being treated for febrile neutropenia with empirical antibiotics
•2.With afebrile period for at least 24 hours
•3.With sterile blood culture at 48 hours
•4.With negative or normalization of procalcitonin at 48 hours
•5.Written informed consent

•Exclusion Criteria during screening
•1.Children receiving intensive phases of chemotherapy
•2.Clinically documented infections which require prolonged duration of antibiotics viz., osteomyelitis, septic arthritis, meningitis, endocarditis, pneumonia, neutropenic enterocolitis etc.
•3.Children whose malignancy is not in remission
•4.Children with grade-3 and grade-4 mucositis
•5.Children with profound neutropenia ANC <100/mm3
•6.Severe organ dysfunction defined by Oxygen requirement >50% FiO2, mechanical ventilation, hemodynamic compromise requiring inotropes/vasoactives, serum creatinine >= 2 x ULN for age or 2-fold increase from baseline, SGOT/SGPT 2 X ULN for age, total bilirubin >= 4 mg/dL, GCS <= 11 or acute deterioration of GCS >= 3 points from baseline
•7.Patients undergoing hematopoietic stem cell transplantation (HSCT)
•Exclusion criteria during randomization at 72-hours
•1.Non availability of reliable and compliant caretaker
•2.Residence >1 hour of reach from the hospital

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