OBJECTIVE: To compare zaldaride maleate, a calmodulin inhibitor with gastrointestinal antisecretory properties, with loperamide and a placebo in the treatment of travellers' diarrhoea. DESIGN: Randomized, double-blind, double-dummy study. SETTING:Study clinic staffed by European residents on Nile cruise ships. PATIENTS: Tourists (n = 436) who acquired travellers' diarrhoea during the Nile cruise. INTERVENTIONS: (1) Zaldaride 20 mg four times daily, (2) zaldaride 2 x 20 mg as initial loading dose followed by three doses of 20 mg on the first day and four doses of 20 mg on the second day, (3) loperamide 2 x 2 mg loading dose following by a flexible dosage of 2 mg after each unformed stool (maximum of 16 mg daily), (4) placebo. MAIN OUTCOME MEASURES: Number of unformed stools, rate of improvement of patients with diarrhoea, rate of relief from diarrhoea. RESULTS: Among the 331 compliant and fully evaluated patients, the zaldaride with loading dose group showed no significant differences in cure rates from the loperamide group. For most parameters, zaldaride without a loading dose and the placebo resulted in significantly lower cure rates. CONCLUSIONS: A zaldaride regimen including a loading dose was shown to be well tolerated and as effective as loperamide.
RCT Entities:
OBJECTIVE: To compare zaldaride maleate, a calmodulin inhibitor with gastrointestinal antisecretory properties, with loperamide and a placebo in the treatment of travellers' diarrhoea. DESIGN: Randomized, double-blind, double-dummy study. SETTING: Study clinic staffed by European residents on Nile cruise ships. PATIENTS: Tourists (n = 436) who acquired travellers' diarrhoea during the Nile cruise. INTERVENTIONS: (1) Zaldaride 20 mg four times daily, (2) zaldaride 2 x 20 mg as initial loading dose followed by three doses of 20 mg on the first day and four doses of 20 mg on the second day, (3) loperamide 2 x 2 mg loading dose following by a flexible dosage of 2 mg after each unformed stool (maximum of 16 mg daily), (4) placebo. MAIN OUTCOME MEASURES: Number of unformed stools, rate of improvement of patients with diarrhoea, rate of relief from diarrhoea. RESULTS: Among the 331 compliant and fully evaluated patients, the zaldaride with loading dose group showed no significant differences in cure rates from the loperamide group. For most parameters, zaldaride without a loading dose and the placebo resulted in significantly lower cure rates. CONCLUSIONS: A zaldaride regimen including a loading dose was shown to be well tolerated and as effective as loperamide.
Authors: Mark S Riddle; Gregory J Martin; Clinton K Murray; Timothy H Burgess; Patrick Connor; James D Mancuso; Elizabeth R Schnaubelt; Timothy P Ballard; Jamie Fraser; David R Tribble Journal: Mil Med Date: 2017-09 Impact factor: 1.437
Authors: Mark S Riddle; Bradley A Connor; Nicholas J Beeching; Herbert L DuPont; Davidson H Hamer; Phyllis Kozarsky; Michael Libman; Robert Steffen; David Taylor; David R Tribble; Jordi Vila; Philipp Zanger; Charles D Ericsson Journal: J Travel Med Date: 2017-04-01 Impact factor: 8.490