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

Ana E. Gamiño-Arroyo, M. Lourdes Guerrero, Sean McCarthy, Alejandra Ramírez-Venegas, Beatriz Llamosas-Gallardo, Arturo Galindo-Fraga, Sarbelio Moreno-Espinosa, Yuri Roldán-Aragón, Javier Araujo-Meléndez, Sally Hunsberger, Violeta Ibarra-González, Julia Martínez-López, Luis A. García-Andrade, Heather Kapushoc, H. Preston Holley, Mary C. Smolskis, Guillermo M. Ruiz-Palacios, John H. Beigel, M. Lourdes Guerrero, Ana E. Gamiño-ArroyoAlejandra Ramírez-Venegas, Nora Bautista, Angélica Nolasco-Reza, Beatriz Llamosas-Gallardo, Ana A. Ortiz-Hernández, Diana Andrade-Platas, Juliana Estevez-Jimenez, Arturo Galindo-Fraga, Bricia Roa-Martínez, Itzel Cruz-Gaona, Diana Aguilar-Cruz, Sarbelio Moreno-Espinosa, Mónica González-Matus, Luis Mendoza-Garcés, Javier Araujo-Meléndez, Norma Perea-Guzmán, Ana Sandoval-Gutiérrez, Daniel Hernández-Ramírez, Pedro Gerardo Hernández-Sánchez, Yuri A. Roldán-Aragón, Alejandra N. Davila-Cruz, Violeta Ibarra-González, Julia Martínez-López, Luis A. García-Andrade, Guillermo M. Ruiz-Palacios, John H. Beigel, Mary Smolskis, Sally Hunsberger, H. Sean McCarthy, Louis Grue, Gregory Burge, Roxanne Cox, Preston Holley, Anthony Cristillo, Nasreen Nahed, Wendolyne López, Eli Xchel Becerril-Ruiz, Peter Quidgley, Hugo Arroyo-Figueroa

Research output: Contribution to journalArticle

19 Scopus citations

Abstract

Background: Effective therapeutics for respiratory viruses are needed. Early data suggest that nitazoxanide (NTZ) may be beneficial for treating acute respiratory viral illness. Methods: 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. Results: 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. Conclusions: 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. Clinical Trials Registration: NCT02057757.

Original languageEnglish (US)
Pages (from-to)1903-1911
Number of pages9
JournalClinical Infectious Diseases
Volume69
Issue number11
DOIs
StatePublished - Nov 13 2019

Keywords

  • hospitalized
  • influenza-like illness
  • nitazoxanide
  • respiratory virus

ASJC Scopus subject areas

  • Microbiology (medical)
  • Infectious Diseases

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    Gamiño-Arroyo, A. E., Guerrero, M. L., McCarthy, S., Ramírez-Venegas, A., Llamosas-Gallardo, B., Galindo-Fraga, A., Moreno-Espinosa, S., Roldán-Aragón, Y., Araujo-Meléndez, J., Hunsberger, S., Ibarra-González, V., Martínez-López, J., García-Andrade, L. A., Kapushoc, H., Holley, H. P., Smolskis, M. C., Ruiz-Palacios, G. M., Beigel, J. H., Guerrero, M. L., ... Arroyo-Figueroa, H. (2019). Efficacy and Safety of Nitazoxanide in Addition to Standard of Care for the Treatment of Severe Acute Respiratory Illness. Clinical Infectious Diseases, 69(11), 1903-1911. https://doi.org/10.1093/cid/ciz100