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

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

    Clin Infect Dis. 2019 Feb 7. doi: 10.1093/cid/ciz100. [Epub ahead of print]
    Efficacy and Safety of Nitazoxanide in Addition to Standard of Care for the Treatment of Severe Acute Respiratory Illness.

    Gami?o-Arroyo AE1, Guerrero ML2, McCarthy S3, Ram?rez-Venegas A4, Llamosas-Gallardo B5, Galindo-Fraga A2, Moreno-Espinosa S1, Rold?n-Arag?n Y6, Araujo-Mel?ndez J7, Hunsberger S8, Ibarra-Gonz?lez V2, Mart?nez-L?pez J2, Garc?a-Andrade LA2, Kapushoc H3, Holley HP Jr8, Smolskis MC8, Ruiz-Palacios GM2,9, Beigel JH10; Mexico Emerging Infectious Diseases Clinical Research Network (LaRed).
    Author information

    Abstract

    Background:

    Effective therapeutics for respiratory viruses are needed. Early data suggest 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 six hospitals in Mexico. Participants were randomized 1:1 to NTZ (≥12 years old, 600 mg twice daily; 4-11 and 1-3 years old, 200 or 100 mg twice daily, respectively) or placebo for 5 days in addition to standard of care. The primary end point was time from first dose to hospital discharge. Influenza RT-PCR and Respifinder 22 multiplex test were used for virus detection. ClinicalTrials.gov, number NCT02057757.
    Results:

    Of 260 participants enrolled, 257 were randomized and took at least one dose of study treatment (ITT population): 130 in the NTZ group and 127 in the placebo group. The Kaplan-Meier estimate of the median duration of hospitalization (interquartiles 25 th, 75 th) in the NTZ group was 6.5 (4.0, 9.0) days versus 7.0 (4.0, 9.0) days in the placebo group (P=0.56). Duration of hospitalization between the two treatments was similar in children (P=0.29) and adults (P=0.62), influenza A and B (P=0.32) and other respiratory viruses. 7(5.4%) and 6(4.7%) participants in the NTZ and placebo groups reported severe adverse events, respectively.
    Conclusions:

    Treatment with nitazoxanide 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 nitazoxanide.


    PMID: 30753384 DOI: 10.1093/cid/ciz100
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