CTRI/2020/01/022997
Not yet recruiting
未知
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
ConditionsHealth Condition 1: C00-D49- Neoplasms
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Health Condition 1: C00-D49- Neoplasms
- Sponsor
- AIIMS
- Status
- Not yet recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
- •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
Outcomes
Primary Outcomes
Not specified
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