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Safety of Procalcitonin Guided Early Discontinuation of Antibiotic Therapy among Children Receiving Cancer Chemotherapy and Having Low-Risk Febrile Neutropenia: A Randomized Feasibility Trial (ProFenC Study).
Srinivasan, Prasanth; Meena, Jagdish Prasad; Gupta, Aditya Kumar; Halder, Ashutosh; Kapil, Arti; Pandey, Ravindra Mohan; Seth, Rachna.
Afiliación
  • Srinivasan P; Division of Pediatric Oncology, Department of Pediatrics, All India Institute of Medical Sciences, New Delhi, India.
  • Meena JP; Division of Pediatric Oncology, Department of Pediatrics, All India Institute of Medical Sciences, New Delhi, India.
  • Gupta AK; Division of Pediatric Oncology, Department of Pediatrics, All India Institute of Medical Sciences, New Delhi, India.
  • Halder A; Department of Reproductive Biology, All India Institute of Medical Sciences, New Delhi, India.
  • Kapil A; Department of Microbiology, All India Institute of Medical Sciences, New Delhi, India.
  • Pandey RM; Department of Biostatistics, All India Institute of Medical Sciences, New Delhi, India.
  • Seth R; Division of Pediatric Oncology, Department of Pediatrics, All India Institute of Medical Sciences, New Delhi, India.
Pediatr Hematol Oncol ; 41(2): 89-102, 2024.
Article en En | MEDLINE | ID: mdl-37655541
In low-risk febrile neutropenia (LR-FN), the safety of early discontinuation of empiric antibiotics without marrow recovery is not well established. This study aimed to evaluate the safety of procalcitonin (PCT) guided early discontinuation of antibiotics in LR-FN. In this trial, children with LR-FN with an afebrile period of at least 24 h, sterile blood culture, and negative/normalized PCT were randomized at 72 h of starting antibiotics into two groups: intervention arm and standard arm. The antibiotics were stopped in the intervention arm regardless of absolute neutrophil count (ANC), while in the standard arm, antibiotics were continued for at least 7 days or until recovery of ANC (>500/mm3). The primary objective was to determine the treatment failure rates, and the secondary objective was to compare the duration of antibiotics and all-cause mortality between the two arms. A total of 46 children with LR-FN were randomized to either the intervention arm (n = 23) or the standard arm (n = 23). Treatment failure was observed in 2/23 (8.7%) of patients in the intervention arm compared to 1/23 (4.3%) in the standard arm [RR: 2 (95% CI: 0.19-20.6); p = 0.55]. The median duration of antibiotics in the intervention arm and standard arm were 3 days vs 7 days (P= <0.001). There was no mortality in this study. PCT-guided early discontinuation of empirical antibiotics in LR-FN is feasible. There was no significant difference observed in treatment failure between the early discontinuation of antibiotics vs standard therapy. The total duration of antibiotic exposure was significantly lesser in the discontinuation arm. Further, larger multicenter studies are needed to confirm the finding of this study.
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Texto completo: 1 Base de datos: MEDLINE Asunto principal: Neutropenia Febril / Neoplasias Tipo de estudio: Clinical_trials / Etiology_studies / Risk_factors_studies Límite: Child / Humans Idioma: En Revista: Pediatr Hematol Oncol Asunto de la revista: HEMATOLOGIA / NEOPLASIAS / PEDIATRIA Año: 2024 Tipo del documento: Article País de afiliación: India

Texto completo: 1 Base de datos: MEDLINE Asunto principal: Neutropenia Febril / Neoplasias Tipo de estudio: Clinical_trials / Etiology_studies / Risk_factors_studies Límite: Child / Humans Idioma: En Revista: Pediatr Hematol Oncol Asunto de la revista: HEMATOLOGIA / NEOPLASIAS / PEDIATRIA Año: 2024 Tipo del documento: Article País de afiliación: India