tetano
Editor, Senior Moderator
Clin Infect Dis. 2019 Feb 7. doi: 10.1093/cid/ciz100. [Epub ahead of print]
[h=1]Efficacy and Safety of Nitazoxanide in Addition to Standard of Care for the Treatment of Severe Acute Respiratory Illness.[/h] Gami?o-Arroyo AE[SUP]1[/SUP], Guerrero ML[SUP]2[/SUP], McCarthy S[SUP]3[/SUP], Ram?rez-Venegas A[SUP]4[/SUP], Llamosas-Gallardo B[SUP]5[/SUP], Galindo-Fraga A[SUP]2[/SUP], Moreno-Espinosa S[SUP]1[/SUP], Rold?n-Arag?n Y[SUP]6[/SUP], Araujo-Mel?ndez J[SUP]7[/SUP], Hunsberger S[SUP]8[/SUP], Ibarra-Gonz?lez V[SUP]2[/SUP], Mart?nez-L?pez J[SUP]2[/SUP], Garc?a-Andrade LA[SUP]2[/SUP], Kapushoc H[SUP]3[/SUP], Holley HP Jr[SUP]8[/SUP], Smolskis MC[SUP]8[/SUP], Ruiz-Palacios GM[SUP]2,[/SUP][SUP]9[/SUP], Beigel JH[SUP]10[/SUP]; Mexico Emerging Infectious Diseases Clinical Research Network (LaRed).
[h=3]Author information[/h]
[h=3]Abstract[/h] [h=4]Background:[/h] Effective therapeutics for respiratory viruses are needed. Early data suggest Nitazoxanide (NTZ) may be beneficial for treating acute respiratory viral illness.
[h=4]Methods:[/h] 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.
[h=4]Results:[/h] 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.
[h=4]Conclusions:[/h] 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
[h=1]Efficacy and Safety of Nitazoxanide in Addition to Standard of Care for the Treatment of Severe Acute Respiratory Illness.[/h] Gami?o-Arroyo AE[SUP]1[/SUP], Guerrero ML[SUP]2[/SUP], McCarthy S[SUP]3[/SUP], Ram?rez-Venegas A[SUP]4[/SUP], Llamosas-Gallardo B[SUP]5[/SUP], Galindo-Fraga A[SUP]2[/SUP], Moreno-Espinosa S[SUP]1[/SUP], Rold?n-Arag?n Y[SUP]6[/SUP], Araujo-Mel?ndez J[SUP]7[/SUP], Hunsberger S[SUP]8[/SUP], Ibarra-Gonz?lez V[SUP]2[/SUP], Mart?nez-L?pez J[SUP]2[/SUP], Garc?a-Andrade LA[SUP]2[/SUP], Kapushoc H[SUP]3[/SUP], Holley HP Jr[SUP]8[/SUP], Smolskis MC[SUP]8[/SUP], Ruiz-Palacios GM[SUP]2,[/SUP][SUP]9[/SUP], Beigel JH[SUP]10[/SUP]; Mexico Emerging Infectious Diseases Clinical Research Network (LaRed).
[h=3]Author information[/h]
[h=3]Abstract[/h] [h=4]Background:[/h] Effective therapeutics for respiratory viruses are needed. Early data suggest Nitazoxanide (NTZ) may be beneficial for treating acute respiratory viral illness.
[h=4]Methods:[/h] 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.
[h=4]Results:[/h] 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.
[h=4]Conclusions:[/h] 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