Study Comparing Nitrofurantoin to Fosfomycin for Acute Urinary Tract Infection in Women
Status:
Unknown status
Trial end date:
2017-08-01
Target enrollment:
Participant gender:
Summary
Developed before the establishment of a structured process for drug assessment,
nitrofurantoin is now being prescribed frequently given the rise in multi-resistant
gram-negative pathogens. Doubts remain regarding fosfomycin's long-term clinical
effectiveness. A randomized, controlled trial is needed to explore the clinical effectiveness
and better define the side effect profiles of both nitrofurantoin and fosfomycin. This
multi-center open trial will randomize 600 non-pregnant women at three international sites
(200 each in Poland, Switzerland, and Israel) at increased risk for carriage of resistant
uropathogens and with suspicion of uncomplicated lower urinary tract infection to receive
either oral nitrofurantoin 100 mg three times daily for 5 days or a single 3g dose of oral
fosfomycin. Patients will be followed for clinical and bacteriologic response at days 14 and
28 post therapy completion. The study hypothesis holds that nitrofurantoin will be superior
to fosfomycin in clinical efficacy at final follow-up.