BACKGROUND:Oseltamivir provides modest clinical benefits to children with influenza when started within 48 hours of symptom onset. The effectiveness of oseltamivir could be substantially greater if the treatment were started earlier during the course of the illness. METHODS: We carried out a randomized, double-blind, placebo-controlled trial of the efficacy of oseltamivir started within 24 hours of symptom onset in children 1-3 years of age with laboratory-confirmed influenza during the seasons of 2007-2008 and 2008-2009. Eligible children received either orally administered oseltamivir suspension or a matching placebo twice daily for 5 days. The children received clinical examinations, and the parents filled out detailed symptom diaries for 21 days. RESULTS: Of 408 randomized children who received the study drug (oseltamivir, 203, and placebo, 205), 98 had laboratory-confirmed influenza (influenza A, 79, and influenza B, 19). When started within 12 hours of the onset of symptoms, oseltamivir decreased the incidence of acute otitis media by 85% (95% confidence interval, 25%-97%), but no significant reduction was observed with treatment started within 24 hours. Among children with influenza A, oseltamivir treatment started within 24 hours shortened the median time to resolution of illness by 3.5 days (3.0 vs 6.5 days; P = .006) in all children and by 4.0 days (3.4 vs 7.3; P = .006) in unvaccinated children and reduced parental work absenteeism by 3.0 days. No efficacy was demonstrated against influenza B infections. CONCLUSIONS:Oseltamivir treatment started within 24 hours of symptom onset provides substantial benefits to children with influenza A infection. Clinical trials registration. ClinicalTrials.gov identifier: NCT00593502.
RCT Entities:
BACKGROUND:Oseltamivir provides modest clinical benefits to children with influenza when started within 48 hours of symptom onset. The effectiveness of oseltamivir could be substantially greater if the treatment were started earlier during the course of the illness. METHODS: We carried out a randomized, double-blind, placebo-controlled trial of the efficacy of oseltamivir started within 24 hours of symptom onset in children 1-3 years of age with laboratory-confirmed influenza during the seasons of 2007-2008 and 2008-2009. Eligible children received either orally administered oseltamivir suspension or a matching placebo twice daily for 5 days. The children received clinical examinations, and the parents filled out detailed symptom diaries for 21 days. RESULTS: Of 408 randomized children who received the study drug (oseltamivir, 203, and placebo, 205), 98 had laboratory-confirmed influenza (influenza A, 79, and influenza B, 19). When started within 12 hours of the onset of symptoms, oseltamivir decreased the incidence of acute otitis media by 85% (95% confidence interval, 25%-97%), but no significant reduction was observed with treatment started within 24 hours. Among children with influenza A, oseltamivir treatment started within 24 hours shortened the median time to resolution of illness by 3.5 days (3.0 vs 6.5 days; P = .006) in all children and by 4.0 days (3.4 vs 7.3; P = .006) in unvaccinated children and reduced parental work absenteeism by 3.0 days. No efficacy was demonstrated against influenza B infections. CONCLUSIONS:Oseltamivir treatment started within 24 hours of symptom onset provides substantial benefits to children with influenza A infection. Clinical trials registration. ClinicalTrials.gov identifier: NCT00593502.
Authors: John S Bradley; Carrie L Byington; Samir S Shah; Brian Alverson; Edward R Carter; Christopher Harrison; Sheldon L Kaplan; Sharon E Mace; George H McCracken; Matthew R Moore; Shawn D St Peter; Jana A Stockwell; Jack T Swanson Journal: Clin Infect Dis Date: 2011-08-31 Impact factor: 9.079
Authors: Timothy M Uyeki; Henry H Bernstein; John S Bradley; Janet A Englund; Thomas M File; Alicia M Fry; Stefan Gravenstein; Frederick G Hayden; Scott A Harper; Jon Mark Hirshon; Michael G Ison; B Lynn Johnston; Shandra L Knight; Allison McGeer; Laura E Riley; Cameron R Wolfe; Paul E Alexander; Andrew T Pavia Journal: Clin Infect Dis Date: 2019-03-05 Impact factor: 9.079
Authors: Mohamed A Kamal; Ronald Gieschke; Annabelle Lemenuel-Diot; Catherine A A Beauchemin; Patrick F Smith; Craig R Rayner Journal: Antimicrob Agents Chemother Date: 2015-06-22 Impact factor: 5.191
Authors: Timothy F Murphy; Tasnee Chonmaitree; Stephen Barenkamp; Jennelle Kyd; Johanna Nokso-Koivisto; Janak A Patel; Terho Heikkinen; Noboru Yamanaka; Pearay Ogra; W Edward Swords; Tania Sih; Melinda M Pettigrew Journal: Otolaryngol Head Neck Surg Date: 2013-04 Impact factor: 3.497
Authors: Barbara J Brennan; Brian Davies; Georgina Cirrincione-Dall; Peter N Morcos; Anna Beryozkina; Colombe Chappey; Pau Aceves Baldó; Sian Lennon-Chrimes; Craig R Rayner Journal: Antimicrob Agents Chemother Date: 2012-06-25 Impact factor: 5.191
Authors: Andrea F Dugas; Alexandra Valsamakis; Mihir R Atreya; Komal Thind; Peter Alarcon Manchego; Annum Faisal; Charlotte A Gaydos; Richard E Rothman Journal: Am J Emerg Med Date: 2015-03-12 Impact factor: 2.469
Authors: Andrea Freyer Dugas; Sara Coleman; Charlotte A Gaydos; Richard E Rothman; Kevin D Frick Journal: Ann Emerg Med Date: 2013-03-20 Impact factor: 5.721