Efficacy and Safety of Nitrofurantoin in the Treatment of Uncomplicated Urinary Tract Infections in Adults
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|ClinicalTrials.gov Identifier: NCT01092351|
Recruitment Status : Completed
First Posted : March 24, 2010
Last Update Posted : March 24, 2010
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.
|Condition or disease||Intervention/treatment||Phase|
|Urinary Tract Infection||Drug: Nitrofurantoin||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||37 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Open Label Study on the Bacteriological and Clinical Efficacy and Safety of a Nitrofurantoin Formulation Given Twice Daily (Bid) for Seven Days in Uncomplicated Urinary Tract Infection in Adults|
|Study Start Date :||January 2007|
|Actual Primary Completion Date :||September 2008|
|Actual Study Completion Date :||September 2008|
Adult patients with a microbiologically confirmed uncomplicated urinary tract infection
100 mg retard capsules to be taken twice daily for seven days
Other Name: Uvamin retard
- Evaluation of bacteriological efficacy [ Time Frame: after 12-42 days ]Bacteriological efficacy is assessed by number and type of isolates in a clean-void midstream urine sample.
- Evaluation of clinical efficacy [ Time Frame: after 12-42 days ]Clinical efficacy is assessed by the disappearance/improvement of clinical symptoms (dysuria, frequency, urgency, suprapubic pain).
- Evaluation of safety and tolerability [ Time Frame: 1-42 days ]Safety and tolerability of the nitrofurantoin formulation is assessed during whole duration of study by monitoring all adverse events
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01092351
|Cif Biotec, Medica Sur|
|Mexico City, Mexico, 14050|
|Principal Investigator:||Arturo Mendoza Valdes, MD||Cif Biotec, Medical Sur|