Uncomplicated Urinary Tract Infection Clinical Trial
Official title:
Pivmecillinam Hydrochloride Tablets Versus Fosfomycin Tromethamine Granules for Uncomplicated Urinary Tract Infection in Women -A Randomized, Double-blind, Double Simulation, Positive Drug Parallel-controlled, Multi Center Phase III Clinical Trial in China
the purpose of this study is to evaluate the efficacy and safety of pivmecillinam hydrochloride tablets in the treatment of uncomplicated urinary tract infection in China
Screening period (D -3 to D -1): complete screening examinations will be performed after the subject signs the informed consent Dosing Treatment Period (D 1 to D 5): subjects who met the inclusion criteria and did not meet the exclusion criteria were randomized. Refer to the randomization protocol for specific randomization process. Safety check (D 5+1): perform on-site visit after 15 doses (D 5+1) Post-treatment follow-up assessments ((D 12±2) and (D 21+7)): subjects returned to the study site for on-site follow-up on Day 12±2 and Day 21+7. Urine bacterial culture and minimal inhibitory concentration (MIC) test: urine bacterial culture is required for subjects. ;
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