Publications by authors named "Rómulo E Rosales-Uribe"

2 Publications

  • Page 1 of 1

Restructuring of a pediatric hospital in the face of the COVID-19 pandemic.

Bol Med Hosp Infant Mex 2020 11;78(1):3-9

Dirección General. Hospital Infantil de México Federico Gómez, Mexico City, Mexico.

Overview of the pandemic In December 2019, a new virus named SARS-CoV-2 was reported in Wuhan province, China. The first case of COVID-19 in Mexico was confirmed on February 28, 2020, and the World Health Organization declared the pandemic on March 11.
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November 2020

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.

Pediatr Blood Cancer 2020 06 20;67(6):e28251. Epub 2020 Mar 20.

Oncology Department, Instituto Nacional de Pediatría, Mexico City, Mexico.

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 < 0.001). The mean duration of antibiotics was 4.1 days (SD 2.5; 95% CI, 3.4-4.8 days) in the outpatient group and 4.4 days (SD 2.5; 95% CI, 3.7-5.0 days) in the inpatient group (P = 0.70).

Conclusions: In our population, step-down oral outpatient treatment of low-risk FN was as safe and effective as inpatient intravenous treatment. Clinical Trials Identifier: NCT04000711.
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June 2020