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Efficacy and Safety of Nitazoxanide in Addition to Standard of Care for the Treatment of Severe Acute Respiratory Illness.

  • Gamiño-Arroyo, Ana E1
  • Guerrero, M Lourdes2
  • McCarthy, Sean3
  • Ramírez-Venegas, Alejandra4
  • Llamosas-Gallardo, Beatriz5
  • Galindo-Fraga, Arturo2
  • Moreno-Espinosa, Sarbelio1
  • Roldán-Aragón, Yuri6
  • Araujo-Meléndez, Javier7
  • Hunsberger, Sally8
  • Ibarra-González, Violeta2
  • Martínez-López, Julia2
  • García-Andrade, Luis A2
  • Kapushoc, Heather3
  • Holley, H Preston8
  • Smolskis, Mary C8
  • Ruiz-Palacios, Guillermo M2, 9
  • Beigel, John H10
  • 1 Hospital Infantil de México "Dr Federico Gómez, Mexico City, Mexico. , (Mexico)
  • 2 Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City, Mexico. , (Mexico)
  • 3 Social and Scientific Systems, Inc, Silver Spring, Maryland.
  • 4 Instituto Nacional de Enfermedades Respiratorias, Mexico City. , (Mexico)
  • 5 Instituto Nacional de Pediatría, Mexico City. , (Mexico)
  • 6 Hospital General "Dr Aurelio Valdivieso," Oaxaca, Mexico. , (Mexico)
  • 7 Hospital Central "Dr Ignacio Morones-Prieto," San Luis Potosi, Mexico. , (Mexico)
  • 8 National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland.
  • 9 Comisión Coordinadora de los Institutos Nacionales de Salud y Hospitales de Alta Especialidad, Secretaría de Salud, Mexico City. , (Mexico)
  • 10 Leidos Biomedical Research, Inc, Frederick National Laboratory for Cancer Research, Maryland.
Published Article
Clinical Infectious Diseases
Oxford University Press
Publication Date
Nov 13, 2019
DOI: 10.1093/cid/ciz100
PMID: 30753384


Effective therapeutics for respiratory viruses are needed. Early data suggest that nitazoxanide (NTZ) may be beneficial for treating acute respiratory viral illness. From March 2014 through March 2017, a double-blind, placebo-controlled trial was conducted in 260 participants ≥1 year old hospitalized with influenza-like illness at 6 hospitals in Mexico. Participants were randomized 1:1 to NTZ (age ≥12 years, 600 mg twice daily; age 4-11 years and 1-3 years, 200 or 100 mg twice daily, respectively) or placebo for 5 days in addition to standard of care. The primary endpoint was time from first dose to hospital discharge. Influenza reverse-transcription polymerase chain reaction and Respifinder 22 multiplex test were used for virus detection. Of 260 participants enrolled, 257 were randomized and took at least 1 dose of study treatment (intention-to-treat population): 130 in the NTZ group and 127 in the placebo group. The Kaplan-Meier estimate of the median duration of hospitalization was 6.5 (interquartile range [IQR], 4.0-9.0) days in the NTZ group vs 7.0 (IQR, 4.0-9.0) days in the placebo group (P = .56). Duration of hospitalization between the 2 treatments was similar in children (P = .29) and adults (P = .62), influenza A and B (P = .32), and other respiratory viruses. Seven (5.4%) and 6 (4.7%) participants in the NTZ and placebo groups, respectively, reported serious adverse events. Treatment with NTZ did not reduce the duration of hospital stay in severe influenza-like illness. Further analyses based on age and evaluations by virus did not reveal any subgroups that appeared to benefit from NTZ. NCT02057757. Published by Oxford University Press for the Infectious Diseases Society of America 2019.

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