Study Comparing Nitrofurantoin to Fosfomycin for Acute Urinary Tract Infection in Women (AIDA-WP2)
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|ClinicalTrials.gov Identifier: NCT01966653|
Recruitment Status : Unknown
Verified May 2017 by Stephen Harbarth, University Hospital, Geneva.
Recruitment status was: Active, not recruiting
First Posted : October 21, 2013
Last Update Posted : May 2, 2017
|Condition or disease||Intervention/treatment||Phase|
|Urinary Tract Infections Cystitis||Drug: nitrofurantoin Drug: fosfomycin||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||600 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Randomised Clinical Trial Comparing Fosfomycin vs. Nitrofurantoin for Treatment of Uncomplicated Lower Urinary Tract Infection in Female Adults at Increased Risk of Antibiotic-resistant Bacterial Infection|
|Actual Study Start Date :||October 2013|
|Estimated Primary Completion Date :||May 2017|
|Estimated Study Completion Date :||August 2017|
Active Comparator: nitrofurantoin
Nitrofurantoin will be given orally at a dose of 100 mg three times daily for 5 days.
nitrofurantoin 100 mg po tid for 5 days
Active Comparator: fosfomycin
A single 3g dose of oral fosfomycin will be given.
fosfomycin 3g po single dose
Other Name: Monuril
- Number of participants with clinical cure, clinical failure, or indeterminate clinical response (see description below) [ Time Frame: at 28 days post therapy completion ]Clinical response is defined as either (1) clinical cure, which in turn is defined as complete resolution of symptoms with no recurrence of symptoms or signs of urinary tract infection; (2) clinical failure, defined as the need for additional, or change in, antibiotic treatment due to a urinary tract infection, OR discontinuation due to lack of efficacy; or (3) indeterminate response, defined as either persistence of symptoms without objective evidence of infection (absence of bacteriuria or pyuria) OR any extenuating circumstances precluding a classification or clinical cure/failure.
- Number of participants with bacteriologic cure and with bacteriologic recurrence [ Time Frame: at 28 days post therapy completion ]Bacteriologic response is defined as either (1) bacteriologic cure, that is, eradication of the infecting strain with no recurrence of bacteriuria (<10x3 cfu/mL) during follow-up; or (2) bacteriologic recurrence, defined as bacteriuria >10x3 cfu/mL. However, bacteriologic recurrence without urinary tract symptoms will be designated asymptomatic bacteriuria and left untreated.
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: within 28 days post therapy completion ]
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): NCT01966653
|Tel Aviv University|
|Tel Aviv, Israel|
|Lodz University Hospital|
|University Hospitals of Geneva|
|Geneva, Switzerland, 1201|
|Principal Investigator:||Stephan Harbarth, MD, MS||University of Geneva|