OBJECTIVE: To compare bacteriologic and clinical efficacy and safety of 10 vs 5 days of cefpodoxime proxetil vs 10 days of penicillin V potassium for the treatment of acute group A beta-hemolytic streptococcal tonsillopharyngitis in children. DESIGN: Prospective, randomized, observer-blind, multicenter study. PATIENTS/ INTERVENTIONS: Four hundred eighty-four children (age range, 2 to 17 years) with signs and symptoms of acute tonsillopharyngitis were enrolled; 377 had a positive throat culture for group A beta-hemolytic streptococci and were fully evaluable. One hundred twenty-one patients receivedcefpodoxime once a day for 10 days, 126 received cefpodoxime twice a day for 5 days, and 130 received penicillin V three times a day for 10 days. RESULTS:Cefpodoxime for 10 days vs cefpodoxime for 5 days vs penicillin V for 10 days produced bacteriologic eradication at the end of therapy in 95%, 90%, and 78% of the patients, respectively. The 10- and 5-day cefpodoxime treatment regimens were more efficacious than penicillin V (P = .003 and P = .02, respectively). The cumulative bacteriologic failure rate among assessable patients by the 32- to 38-day posttreatment visit was 20 (17%) of 121 patients who were treated with cefpodoxime for 10 days, 24 (19%) of 125 patients who were treated with cefpodoxime for 5 days, and 45 (35%) of 130 patients who were treated with penicillin V for 10 days (P = .001 and P = .005, respectively). Clinical cure or improvement was observed at the end of therapy in 96%, 94%, and 91% of the patients, respectively (P = not significant). Adverse events were infrequent and similar in all three treatment groups, with minor gastrointestinal side effects predominating. CONCLUSIONS: Five days of treatment with cefpodoxime is as efficacious in bacteriologic eradication and clinical response (cure plus improvement) as 10 days of cefpodoxime therapy, and both cefpodoxime regimens produced superior bacteriologic efficacy compared with a 10-day regimen of penicillin V in the treatment of group A beta-hemolytic streptococcal tonsillopharyngitis in children.
RCT Entities:
OBJECTIVE: To compare bacteriologic and clinical efficacy and safety of 10 vs 5 days of cefpodoxime proxetil vs 10 days of penicillin Vpotassium for the treatment of acute group A beta-hemolytic streptococcal tonsillopharyngitis in children. DESIGN: Prospective, randomized, observer-blind, multicenter study. PATIENTS/ INTERVENTIONS: Four hundred eighty-four children (age range, 2 to 17 years) with signs and symptoms of acute tonsillopharyngitis were enrolled; 377 had a positive throat culture for group A beta-hemolytic streptococci and were fully evaluable. One hundred twenty-one patients received cefpodoxime once a day for 10 days, 126 received cefpodoxime twice a day for 5 days, and 130 received penicillin V three times a day for 10 days. RESULTS:Cefpodoxime for 10 days vs cefpodoxime for 5 days vs penicillin V for 10 days produced bacteriologic eradication at the end of therapy in 95%, 90%, and 78% of the patients, respectively. The 10- and 5-day cefpodoxime treatment regimens were more efficacious than penicillin V (P = .003 and P = .02, respectively). The cumulative bacteriologic failure rate among assessable patients by the 32- to 38-day posttreatment visit was 20 (17%) of 121 patients who were treated with cefpodoxime for 10 days, 24 (19%) of 125 patients who were treated with cefpodoxime for 5 days, and 45 (35%) of 130 patients who were treated with penicillin V for 10 days (P = .001 and P = .005, respectively). Clinical cure or improvement was observed at the end of therapy in 96%, 94%, and 91% of the patients, respectively (P = not significant). Adverse events were infrequent and similar in all three treatment groups, with minor gastrointestinal side effects predominating. CONCLUSIONS: Five days of treatment with cefpodoxime is as efficacious in bacteriologic eradication and clinical response (cure plus improvement) as 10 days of cefpodoxime therapy, and both cefpodoxime regimens produced superior bacteriologic efficacy compared with a 10-day regimen of penicillin V in the treatment of group A beta-hemolytic streptococcal tonsillopharyngitis in children.
Authors: James M Musser; Stephen B Beres; Luchang Zhu; Randall J Olsen; Jaana Vuopio; Hanne-Leena Hyyryläinen; Kirsi Gröndahl-Yli-Hannuksela; Karl G Kristinsson; Jessica Darenberg; Birgitta Henriques-Normark; Steen Hoffmann; Dominque A Caugant; Andrew J Smith; Diane S J Lindsay; David M Boragine; Timothy Palzkill Journal: J Clin Microbiol Date: 2020-03-25 Impact factor: 5.948
Authors: D Henry; G E Ruoff; J Rhudy; A Puopolo; M Drehobl; J Schoenberger; G Giguere; J J Collins Journal: Antimicrob Agents Chemother Date: 1995-11 Impact factor: 5.191