Dataset Information

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

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.

SUBMITTER: Gamino-Arroyo AE

PROVIDER: S-EPMC6853643 | biostudies-literature | 2019 Nov

REPOSITORIES: biostudies-literature

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Publications

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

Gamiño-Arroyo Ana E AE Guerrero M Lourdes ML McCarthy Sean S Ramírez-Venegas Alejandra A Llamosas-Gallardo Beatriz B Galindo-Fraga Arturo A Moreno-Espinosa Sarbelio S Roldán-Aragón Yuri Y Araujo-Meléndez Javier J Hunsberger Sally S Ibarra-González Violeta V Martínez-López Julia J García-Andrade Luis A LA Kapushoc Heather H Holley H Preston HP Smolskis Mary C MC Ruiz-Palacios Guillermo M GM Beigel John H JH

Clinical infectious diseases : an official publication of the Infectious Diseases Society of America 20191101 11

<h4>Background</h4>Effective therapeutics for respiratory viruses are needed. Early data suggest that nitazoxanide (NTZ) may be beneficial for treating acute respiratory viral illness.<h4>Methods</h4>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 ...[more]

PMID: 30753384

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Dataset Information

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

Background

Methods

Results

Conclusions

Clinical trials registration

Publications

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

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