The study aims to investigate bacteriological efficacy of a nitrofurantoin formulation given twice daily for seven days in the treatment of adult patients with microbiologically confirmed uncomplicated urinary tract infection. Additional study objectives are to evaluate clinical efficacy as well as safety and tolerability of the nitrofurantoin formulation.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
37
100 mg retard capsules to be taken twice daily for seven days
Cif Biotec, Medica Sur
Mexico City, Mexico
Evaluation of bacteriological efficacy
Bacteriological efficacy is assessed by number and type of isolates in a clean-void midstream urine sample.
Time frame: after 12-42 days
Evaluation of clinical efficacy
Clinical efficacy is assessed by the disappearance/improvement of clinical symptoms (dysuria, frequency, urgency, suprapubic pain).
Time frame: after 12-42 days
Evaluation of safety and tolerability
Safety and tolerability of the nitrofurantoin formulation is assessed during whole duration of study by monitoring all adverse events
Time frame: 1-42 days
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