Efficacy and safety of withholding antimicrobial treatment in children with cancer, fever and neutropenia, with a demonstrated viral respiratory infection: a randomized clinical trial. Santolaya, M E, Alvarez, A M, Acuna, M, Aviles, C L, Salgado, C, Tordecilla, J, Varas, M, Venegas, M, Villarroel, M, Zubieta, M, Toso, A, Bataszew, A, Farfan, M J, de la Maza, V, Vergara, A, Valenzuela, R, & Torres, J P Clinical microbiology and infection : the official publication of the European Society of Clinical Microbiology and Infectious Diseases, 23(3):173--178, 2017. Santolaya, M E. Department of Paediatrics, Hospital Dr Luis Calvo Mackenna, Faculty of Medicine, Universidad de Chile, Santiago, Chile; Committee of Infectious Diseases, National Child Programme of Antineoplastic Drugs Network, Santiago, Chile. Alvarez, A M. Department of Paediatrics, Hospital San Juan de Dios, Faculty of Medicine, Universidad de Chile, Santiago, Chile; Committee of Infectious Diseases, National Child Programme of Antineoplastic Drugs Network, Santiago, Chile. Acuna, M. Department of Paediatrics, Hospital Dr Roberto del Rio, Faculty of Medicine, Universidad de Chile, Santiago, Chile; Committee of Infectious Diseases, National Child Programme of Antineoplastic Drugs Network, Santiago, Chile. Aviles, C L. Department of Paediatrics, Hospital San Borja Arriaran, Faculty of Medicine, Universidad de Chile, Santiago, Chile; Committee of Infectious Diseases, National Child Programme of Antineoplastic Drugs Network, Santiago, Chile. Salgado, C. Department of Paediatrics, Hospital Dr Exequiel Gonzalez Cortes, Santiago, Chile; Committee of Infectious Diseases, National Child Programme of Antineoplastic Drugs Network, Santiago, Chile. Tordecilla, J. Department of Paediatrics, Hospital Dr Roberto del Rio, Faculty of Medicine, Universidad de Chile, Santiago, Chile; Committee of Infectious Diseases, National Child Programme of Antineoplastic Drugs Network, Santiago, Chile. Varas, M. Department of Paediatrics, Hospital San Juan de Dios, Faculty of Medicine, Universidad de Chile, Santiago, Chile; Committee of Infectious Diseases, National Child Programme of Antineoplastic Drugs Network, Santiago, Chile. Venegas, M. Department of Paediatrics, Hospital San Juan de Dios, Faculty of Medicine, Universidad de Chile, Santiago, Chile. Villarroel, M. Department of Paediatrics, Hospital Dr Luis Calvo Mackenna, Faculty of Medicine, Universidad de Chile, Santiago, Chile; Committee of Infectious Diseases, National Child Programme of Antineoplastic Drugs Network, Santiago, Chile. Zubieta, M. Department of Paediatrics, Hospital Dr Exequiel Gonzalez Cortes, Santiago, Chile; Committee of Infectious Diseases, National Child Programme of Antineoplastic Drugs Network, Santiago, Chile. Toso, A. Department of Paediatrics, Hospital Dr Luis Calvo Mackenna, Faculty of Medicine, Universidad de Chile, Santiago, Chile. Bataszew, A. Department of Paediatrics, Hospital Dr Luis Calvo Mackenna, Faculty of Medicine, Universidad de Chile, Santiago, Chile. Farfan, M J. Department of Paediatrics, Hospital Dr Luis Calvo Mackenna, Faculty of Medicine, Universidad de Chile, Santiago, Chile. de la Maza, V. Department of Paediatrics, Hospital Dr Luis Calvo Mackenna, Faculty of Medicine, Universidad de Chile, Santiago, Chile. Vergara, A. Centre for Molecular Studies, Hospital Dr Luis Calvo Mackenna, Faculty of Medicine, Universidad de Chile, Santiago, Chile. Valenzuela, R. Department of Paediatrics, Hospital Dr Luis Calvo Mackenna, Faculty of Medicine, Universidad de Chile, Santiago, Chile. Torres, J P. Department of Paediatrics, Hospital Dr Luis Calvo Mackenna, Faculty of Medicine, Universidad de Chile, Santiago, Chile. Electronic address: jptorres@clc.cl.
abstract   bibtex   
OBJECTIVES: To determine efficacy and safety of withholding antimicrobials in children with cancer, fever and neutropenia (FN) with a demonstrated respiratory viral infection., METHODS: Prospective, multicentre, randomized study in children presenting with FN at five hospitals in Santiago, Chile, evaluated at admission for diagnosis of bacterial and viral pathogens including PCR-microarray for 17 respiratory viruses. Children positive for a respiratory virus, negative for a bacterial pathogen and with a favourable evolution after 48 h of antimicrobial therapy were randomized to either maintain or withhold antimicrobials. Primary endpoint was percentage of episodes with uneventful resolution. Secondary endpoints were days of fever/hospitalization, bacterial infection, sepsis, admission to paediatric intensive care unit (PICU) and death., RESULTS: A total of 319 of 951 children with FN episodes recruited between July 2012 and December 2015 had a respiratory virus as a unique identified microorganism, of which 176 were randomized, 92 to maintain antimicrobials and 84 to withdraw. Median duration of antimicrobial use was 7 days (range 7-9 days) versus 3 days (range 3-4 days), with similar frequency of uneventful resolution (89/92 (97%) and 80/84 (95%), respectively, not significant; OR 1.48; 95% CI 0.32-6.83, p 0.61), and similar number of days of fever (2 versus 1), days of hospitalization (6 versus 6) and bacterial infections throughout the episode (2%-1%), with one case of sepsis requiring admission to PICU in the group that maintained antimicrobials, without any deaths., CONCLUSIONS: The reduction of antimicrobials in children with FN and respiratory viral infections, based on clinical and microbiological/molecular diagnostic criteria, should favour the adoption of evidence-based management strategies in this population., Copyright © 2016 European Society of Clinical Microbiology and Infectious Diseases. Published by Elsevier Ltd. All rights reserved.
@article{santolaya_efficacy_2017,
	title = {Efficacy and safety of withholding antimicrobial treatment in children with cancer, fever and neutropenia, with a demonstrated viral respiratory infection: a randomized clinical trial.},
	volume = {23},
	issn = {1469-0691},
	abstract = {OBJECTIVES: To determine efficacy and safety of withholding antimicrobials in children with cancer, fever and neutropenia (FN) with a demonstrated respiratory viral infection., METHODS: Prospective, multicentre, randomized study in children presenting with FN at five hospitals in Santiago, Chile, evaluated at admission for diagnosis of bacterial and viral pathogens including PCR-microarray for 17 respiratory viruses. Children positive for a respiratory virus, negative for a bacterial pathogen and with a favourable evolution after 48 h of antimicrobial therapy were randomized to either maintain or withhold antimicrobials. Primary endpoint was percentage of episodes with uneventful resolution. Secondary endpoints were days of fever/hospitalization, bacterial infection, sepsis, admission to paediatric intensive care unit (PICU) and death., RESULTS: A total of 319 of 951 children with FN episodes recruited between July 2012 and December 2015 had a respiratory virus as a unique identified microorganism, of which 176 were randomized, 92 to maintain antimicrobials and 84 to withdraw. Median duration of antimicrobial use was 7 days (range 7-9 days) versus 3 days (range 3-4 days), with similar frequency of uneventful resolution (89/92 (97\%) and 80/84 (95\%), respectively, not significant; OR 1.48; 95\% CI 0.32-6.83, p 0.61), and similar number of days of fever (2 versus 1), days of hospitalization (6 versus 6) and bacterial infections throughout the episode (2\%-1\%), with one case of sepsis requiring admission to PICU in the group that maintained antimicrobials, without any deaths., CONCLUSIONS: The reduction of antimicrobials in children with FN and respiratory viral infections, based on clinical and microbiological/molecular diagnostic criteria, should favour the adoption of evidence-based management strategies in this population., Copyright © 2016 European Society of Clinical Microbiology and Infectious Diseases. Published by Elsevier Ltd. All rights reserved.},
	number = {3},
	journal = {Clinical microbiology and infection : the official publication of the European Society of Clinical Microbiology and Infectious Diseases},
	author = {Santolaya, M E and Alvarez, A M and Acuna, M and Aviles, C L and Salgado, C and Tordecilla, J and Varas, M and Venegas, M and Villarroel, M and Zubieta, M and Toso, A and Bataszew, A and Farfan, M J and de la Maza, V and Vergara, A and Valenzuela, R and Torres, J P},
	year = {2017},
	note = {Santolaya, M E. Department of Paediatrics, Hospital Dr Luis Calvo Mackenna, Faculty of Medicine, Universidad de Chile, Santiago, Chile; Committee of Infectious Diseases, National Child Programme of Antineoplastic Drugs Network, Santiago, Chile.
Alvarez, A M. Department of Paediatrics, Hospital San Juan de Dios, Faculty of Medicine, Universidad de Chile, Santiago, Chile; Committee of Infectious Diseases, National Child Programme of Antineoplastic Drugs Network, Santiago, Chile.
Acuna, M. Department of Paediatrics, Hospital Dr Roberto del Rio, Faculty of Medicine, Universidad de Chile, Santiago, Chile; Committee of Infectious Diseases, National Child Programme of Antineoplastic Drugs Network, Santiago, Chile.
Aviles, C L. Department of Paediatrics, Hospital San Borja Arriaran, Faculty of Medicine, Universidad de Chile, Santiago, Chile; Committee of Infectious Diseases, National Child Programme of Antineoplastic Drugs Network, Santiago, Chile.
Salgado, C. Department of Paediatrics, Hospital Dr Exequiel Gonzalez Cortes, Santiago, Chile; Committee of Infectious Diseases, National Child Programme of Antineoplastic Drugs Network, Santiago, Chile.
Tordecilla, J. Department of Paediatrics, Hospital Dr Roberto del Rio, Faculty of Medicine, Universidad de Chile, Santiago, Chile; Committee of Infectious Diseases, National Child Programme of Antineoplastic Drugs Network, Santiago, Chile.
Varas, M. Department of Paediatrics, Hospital San Juan de Dios, Faculty of Medicine, Universidad de Chile, Santiago, Chile; Committee of Infectious Diseases, National Child Programme of Antineoplastic Drugs Network, Santiago, Chile.
Venegas, M. Department of Paediatrics, Hospital San Juan de Dios, Faculty of Medicine, Universidad de Chile, Santiago, Chile.
Villarroel, M. Department of Paediatrics, Hospital Dr Luis Calvo Mackenna, Faculty of Medicine, Universidad de Chile, Santiago, Chile; Committee of Infectious Diseases, National Child Programme of Antineoplastic Drugs Network, Santiago, Chile.
Zubieta, M. Department of Paediatrics, Hospital Dr Exequiel Gonzalez Cortes, Santiago, Chile; Committee of Infectious Diseases, National Child Programme of Antineoplastic Drugs Network, Santiago, Chile.
Toso, A. Department of Paediatrics, Hospital Dr Luis Calvo Mackenna, Faculty of Medicine, Universidad de Chile, Santiago, Chile.
Bataszew, A. Department of Paediatrics, Hospital Dr Luis Calvo Mackenna, Faculty of Medicine, Universidad de Chile, Santiago, Chile.
Farfan, M J. Department of Paediatrics, Hospital Dr Luis Calvo Mackenna, Faculty of Medicine, Universidad de Chile, Santiago, Chile.
de la Maza, V. Department of Paediatrics, Hospital Dr Luis Calvo Mackenna, Faculty of Medicine, Universidad de Chile, Santiago, Chile.
Vergara, A. Centre for Molecular Studies, Hospital Dr Luis Calvo Mackenna, Faculty of Medicine, Universidad de Chile, Santiago, Chile.
Valenzuela, R. Department of Paediatrics, Hospital Dr Luis Calvo Mackenna, Faculty of Medicine, Universidad de Chile, Santiago, Chile.
Torres, J P. Department of Paediatrics, Hospital Dr Luis Calvo Mackenna, Faculty of Medicine, Universidad de Chile, Santiago, Chile. Electronic address: jptorres@clc.cl.},
	keywords = {*Anti-Infective Agents/ad [Administration \& Dosage], *Respiratory Tract Infections/dt [Drug Therapy], *Virus Diseases/dt [Drug Therapy], *Withholding Treatment, *febrile neutropenia/dt [Drug Therapy], Child, Child, Preschool, Chile, Hospitals, Humans, Infant, Newborn, Neoplasms/co [Complications], Prospective Studies, adolescent, infant, male, treatment outcome},
	pages = {173--178}
}

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