Safety and efficacy of step-down to oral outpatient treatment versus inpatient antimicrobial treatment in pediatric cancer patients with febrile neutropenia: A noninferiority multicenter randomized clinical trial
| Autor: | Alfonso Reyes-López, Martha J. Avilés‐Robles, Juan Garduño-Espinosa, Marta Zapata-Tarrés, Amilcar U. Valencia‐Garin, Luis E. Juárez-Villegas, Onofre Muñoz-Hernández, José G. Peñaloza‐González, Rómulo Erick Rosales-Uribe, Francisco Otero-Mendoza |
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| Rok vydání: | 2019 |
| Předmět: |
Male
medicine.medical_specialty Cefepime Population Administration Oral Equivalence Trials as Topic Neutropenia law.invention 03 medical and health sciences 0302 clinical medicine Randomized controlled trial law Risk Factors Internal medicine Outpatients Medicine Humans education Child Infusions Intravenous Febrile Neutropenia education.field_of_study Inpatients business.industry Hematology medicine.disease Prognosis Pediatric cancer Anti-Bacterial Agents Clinical trial Hospitalization Oncology 030220 oncology & carcinogenesis Child Preschool Pediatrics Perinatology and Child Health Female business Cefixime Febrile neutropenia 030215 immunology medicine.drug Follow-Up Studies |
| Zdroj: | Pediatric bloodcancerREFERENCES. 67(6) |
| ISSN: | 1545-5017 |
| Popis: | BACKGROUND It has been suggested that low-risk febrile neutropenia (FN) episodes can be treated in a step-down manner in the outpatient setting. This recommendation has been limited to implementation in middle-income countries due to concerns about infrastructure and lack of trained personnel. We aimed to determine whether early step-down to oral antimicrobial outpatient treatment is not inferior in safety and efficacy to inpatient intravenous treatment in children with low-risk FN. PROCEDURE A noninferiority randomized controlled clinical trial was conducted in three hospitals in Mexico City. Low-risk FN was identified in children younger than 18 years. After 48 to 72 hours of intravenous treatment, children were randomly allocated to receive outpatient oral treatment (experimental arm, cefixime) or to continue inpatient treatment (standard of care, cefepime). Daily monitoring was performed until neutropenia resolution. The presence of any unfavorable clinical outcome was the endpoint of interest. We performed a noninferiority test for comparison of proportions. RESULTS We identified 1237 FN episodes; 117 cases were randomized: 60 to the outpatient group and 57 for continued inpatient treatment. Of the FN episodes, 100% in the outpatient group and 93% in the inpatient group had a favorable outcome (P |
| Databáze: | OpenAIRE |
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