Gagandeep Kang1, Sowmyanarayanan V Thuppal, Rajan Srinivasan, Rajiv Sarkar, Beula Subashini, Srinivasan Venugopal, Kulandaipalayam Sindhu, Dhivya Anbu, Nathalie Parez, Lennart Svensson, Anuradha Bose. 1. Departments of Gastrointestinal Sciences, Christian Medical College, Vellore, India; *Service des Urgences Pediatriques, Hopital d enfants Armand Trousseau, Assistance Publique-Hopitaux de Paris, Paris, France; #Division of Molecular Virology, Department of Clinical and Experimental Medicine, Medical Faculty, Linko ping University, Linko ping, Sweden; and $Community Health, Christian Medical College, Vellore, India. Correspondence to: Dr. Gagandeep Kang, Professor and Head, Division of Gastrointestinal Sciences, Christian Medical College, Vellore, India. gkang@cmcvellore.ac.in.
Abstract
OBJECTIVE: To study the effect of racecadotril on reduction in the duration of acute rotavirus and non-rotavirus diarrhea. DESIGN: Two randomized double-blind placebo-controlled trials. SETTING:Community-based trial in an urban area in Vellore, hospital-based trial at a secondary hospital in Vellore. PARTICIPANTS: 199 and 130 3-59 month old children in the community- and hospital-based trials, respectively. METHODS:Racecadotril (1.5 mg/kg/dose, thrice a day for three days) or placebo were given to manage acute diarrhea in both trials. MAIN OUTCOME MEASURE: Median duration of diarrhea. RESULTS: Among 124 children completing the hospital trial, the median duration of diarrhea was 25 h in both arms (P=0.5); median total stool weight was 74 g/kg and 53.5 g/kg in racecadotril group and placebo group, respectively (P=0.4); and average fluid intake per day was 3.6 mL/kg/h and 3mL/kg/h in racecadotril and placebo arms, respectively (P=0.3). Among rotavirus-positive children, median duration of diarrhea was 26.9 h and 30.2 h in racecadotril and placebo arms, respectively (P=0.7). In the community, 196 completed the trial, the median duration of diarrhea was 2 days for both arms (P=0.8) and rotavirus positive children had similar outcomes with median diarrheal duration of 3 d in both arms (P=0.4). CONCLUSIONS: Treatment with racecadotril did not reduce diarrheal duration, stool volume or the requirement for fluid replacement in children with acute gastroenteritis, both with and without rotavirus infection.
RCT Entities:
OBJECTIVE: To study the effect of racecadotril on reduction in the duration of acute rotavirus and non-rotavirus diarrhea. DESIGN: Two randomized double-blind placebo-controlled trials. SETTING: Community-based trial in an urban area in Vellore, hospital-based trial at a secondary hospital in Vellore. PARTICIPANTS: 199 and 130 3-59 month old children in the community- and hospital-based trials, respectively. METHODS:Racecadotril (1.5 mg/kg/dose, thrice a day for three days) or placebo were given to manage acute diarrhea in both trials. MAIN OUTCOME MEASURE: Median duration of diarrhea. RESULTS: Among 124 children completing the hospital trial, the median duration of diarrhea was 25 h in both arms (P=0.5); median total stool weight was 74 g/kg and 53.5 g/kg in racecadotril group and placebo group, respectively (P=0.4); and average fluid intake per day was 3.6 mL/kg/h and 3mL/kg/h in racecadotril and placebo arms, respectively (P=0.3). Among rotavirus-positive children, median duration of diarrhea was 26.9 h and 30.2 h in racecadotril and placebo arms, respectively (P=0.7). In the community, 196 completed the trial, the median duration of diarrhea was 2 days for both arms (P=0.8) and rotavirus positive children had similar outcomes with median diarrheal duration of 3 d in both arms (P=0.4). CONCLUSIONS: Treatment with racecadotril did not reduce diarrheal duration, stool volume or the requirement for fluid replacement in children with acute gastroenteritis, both with and without rotavirus infection.
Authors: Tammy Bui; Guohua Li; Inyoung Kim; Ke Wen; Erica L Twitchell; Shaoh Hualei; Ashwin K Ramesh; Mariah D Weiss; Xingdong Yang; Sherrie G Glark-Deener; Robert Km Choy; Lijuan Yuan Journal: Comp Med Date: 2017-03-01 Impact factor: 0.982
Authors: Sue E Crawford; Sasirekha Ramani; Jacqueline E Tate; Umesh D Parashar; Lennart Svensson; Marie Hagbom; Manuel A Franco; Harry B Greenberg; Miguel O'Ryan; Gagandeep Kang; Ulrich Desselberger; Mary K Estes Journal: Nat Rev Dis Primers Date: 2017-11-09 Impact factor: 52.329
Authors: Minesh P Shah; Jacqueline E Tate; Jason M Mwenda; A Duncan Steele; Umesh D Parashar Journal: Expert Rev Vaccines Date: 2017-09-04 Impact factor: 5.217