BACKGROUND: Although the recommended standard course of therapy for shigellosis is 5 days of oral ampicillin or trimethoprim-sulfamethoxazole therapy, successful outcome has been reported in adults treated with abbreviated courses of antibiotics. The purpose of this study was to compare short course (2-day) vs. 5-day therapy with cefixime for treatment of diarrheal disease caused by Shigella sonnei in children. METHODS: This was a prospective, randomized, double blind, placebo-controlled study. Patients were eligible if they were at least 6 months of age and presented to the Children's Hospital of Pittsburgh during an outbreak of diarrhea caused by S. sonnei, with (1) a history of fever and diarrhea (at least three loose or watery stools per day), (2) bloody diarrhea or (3) diarrhea and known exposure to an individual with documented shigellosis. Patients were randomized to receive either 2 days of cefixime (8 mg/kg(day) given once daily followed by 3 days of placebo or 5 days of cefixime. Telephone follow-up was performed on Days 3, 7 and 14 after enrollment. Follow-up stool cultures were obtained on Day 7 to assess bacteriologic cure. There were standardized definitions for cure, improvement, failure and relapse. RESULTS:Forty-seven patients were enrolled. Eleven were eliminated from analysis because their stool cultures were not positive for S. sonnei. There were 36 evaluable patients, 21 in the 2-day group and 15 in the 5-day group. Patients ranged in age from 6 months to 17 years. Forty-four percent of the subjects were male. Symptoms were improved or had resolved by Day 3 of therapy in all patients. There were 8 patients who experienced a clinical relapse: 5 of 21 (24%) patients in the 2-day treatment group and 3 of 15 (20%) in the 5-day group. There were 13 patients who experienced a bacteriologic failure (defined as the occurrence of a positive culture at the Day 7 follow-up visit), 11 of 20 (55%) in the 2-day group and 2 of 14 (14%) in the 5-day group (P < 0.02). CONCLUSION: Two- and 5-day treatment courses with cefixime for treatment of diarrheal disease caused by S. sonnei result in similar rates of clinical cure and clinical relapses; however, there was a higher rate of bacteriologic failure with shorter course therapy.
RCT Entities:
BACKGROUND: Although the recommended standard course of therapy for shigellosis is 5 days of oral ampicillin or trimethoprim-sulfamethoxazole therapy, successful outcome has been reported in adults treated with abbreviated courses of antibiotics. The purpose of this study was to compare short course (2-day) vs. 5-day therapy with cefixime for treatment of diarrheal disease caused by Shigella sonnei in children. METHODS: This was a prospective, randomized, double blind, placebo-controlled study. Patients were eligible if they were at least 6 months of age and presented to the Children's Hospital of Pittsburgh during an outbreak of diarrhea caused by S. sonnei, with (1) a history of fever and diarrhea (at least three loose or watery stools per day), (2) bloody diarrhea or (3) diarrhea and known exposure to an individual with documented shigellosis. Patients were randomized to receive either 2 days of cefixime (8 mg/kg(day) given once daily followed by 3 days of placebo or 5 days of cefixime. Telephone follow-up was performed on Days 3, 7 and 14 after enrollment. Follow-up stool cultures were obtained on Day 7 to assess bacteriologic cure. There were standardized definitions for cure, improvement, failure and relapse. RESULTS: Forty-seven patients were enrolled. Eleven were eliminated from analysis because their stool cultures were not positive for S. sonnei. There were 36 evaluable patients, 21 in the 2-day group and 15 in the 5-day group. Patients ranged in age from 6 months to 17 years. Forty-four percent of the subjects were male. Symptoms were improved or had resolved by Day 3 of therapy in all patients. There were 8 patients who experienced a clinical relapse: 5 of 21 (24%) patients in the 2-day treatment group and 3 of 15 (20%) in the 5-day group. There were 13 patients who experienced a bacteriologic failure (defined as the occurrence of a positive culture at the Day 7 follow-up visit), 11 of 20 (55%) in the 2-day group and 2 of 14 (14%) in the 5-day group (P < 0.02). CONCLUSION: Two- and 5-day treatment courses with cefixime for treatment of diarrheal disease caused by S. sonnei result in similar rates of clinical cure and clinical relapses; however, there was a higher rate of bacteriologic failure with shorter course therapy.
Authors: Jennifer P Collins; Cindy R Friedman; Meseret G Birhane; Beth E Karp; Anthony Osinski; Mary W Montgomery; Deepam Thomas; Jonathan Barkley; Martha C Sanchez; Samir Hanna; Azizat A Adediran; Jessica C Chen; Hayat Caidi; Louise Francois Watkins Journal: Open Forum Infect Dis Date: 2020-04-18 Impact factor: 3.835
Authors: James A Platts-Mills; Jie Liu; Elizabeth T Rogawski; Furqan Kabir; Paphavee Lertsethtakarn; Mery Siguas; Shaila S Khan; Ira Praharaj; Arinao Murei; Rosemary Nshama; Buliga Mujaga; Alexandre Havt; Irene A Maciel; Timothy L McMurry; Darwin J Operario; Mami Taniuchi; Jean Gratz; Suzanne E Stroup; James H Roberts; Adil Kalam; Fatima Aziz; Shahida Qureshi; M Ohedul Islam; Pimmada Sakpaisal; Sasikorn Silapong; Pablo P Yori; Revathi Rajendiran; Blossom Benny; Monica McGrath; Benjamin J J McCormick; Jessica C Seidman; Dennis Lang; Michael Gottlieb; Richard L Guerrant; Aldo A M Lima; Jose Paulo Leite; Amidou Samie; Pascal O Bessong; Nicola Page; Ladaporn Bodhidatta; Carl Mason; Sanjaya Shrestha; Ireen Kiwelu; Estomih R Mduma; Najeeha T Iqbal; Zulfiqar A Bhutta; Tahmeed Ahmed; Rashidul Haque; Gagandeep Kang; Margaret N Kosek; Eric R Houpt Journal: Lancet Glob Health Date: 2018-10-01 Impact factor: 26.763