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

Authors
Category Primary study
Registry of TrialsClinical Trials Registry - India
Year 2018
INTERVENTION: Intervention1: ARM A: Empirical antibiotic therapy discontinuation will occur when the patient is afebrile, with resolution of signs, symptoms and test abnormalities and normalization of vital signs for â?Â¥ 72 h without recovery of neutrophil 500/mm3 Antibiotics are given in standard doses and route as per recommendations Control Intervention1: ARM B: Empirical antibiotic therapy discontinuation will occur when the neutrophil count is above 500/mm3 and the patient is afebrile, with resolution of signs, symptoms and test abnormalities and normalization of vital signs for â?Â¥ 72 h. Antibiotics are given in standard doses and route as per recommendations CONDITION: Leukemia, unspecified PRIMARY OUTCOME: Recurrent feverTimepoint: daily until 35 days of start of chemotherapy SECONDARY OUTCOME: Adverse events (Nausea, vomiting)Timepoint: Daily until day 35 from start of chemotherapy Antibiotic durationTimepoint: Until Day 35 of start of chemotherapy MortalityTimepoint: Until Day 35 of start of chemotherapy Procalcitonin levelTimepoint: At onset of fever ; At stoppage of antibiotics ; At neutrophils 500/mm3 ; At Recurrance of fever Re‐admission rate ; Timepoint: Until Day 35 of start of chemotherapy Renal dysfunctionTimepoint: Alternate day until day 35 of start of chemotherapy Requirement of third line antibiotics and therapeutic anti‐fungalTimepoint: Until Day 35 of start of chemotherapy 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
Epistemonikos ID: cddb2ef1379590404b9039ee3bf7b495dcd85516
First added on: Jan 21, 2022