Clinical Question

Is a five-day course of nitrofurantoin as effective as single-dose fosfomycin (Monurol) in the treatment of women with uncomplicated lower urinary tract infection (UTI)?

Bottom Line

A five-day course of nitrofurantoin is significantly more likely than single-dose fosfomycin to achieve both clinical and microbiologic resolution of uncomplicated lower UTI in otherwise healthy adult women. (Level of Evidence = 1b–)

Synopsis

The investigators identified women, 18 years and older, who presented with at least one symptom of acute lower UTI, including dysuria, urgency, frequency, or suprapubic tenderness, and a urine dipstick result positive for nitrites or leukocyte esterase. Exclusion criteria included pregnancy, lactation, suspected upper UTI, antibiotic treatment for a UTI in the previous four weeks, indwelling urinary catheter, or immunosuppression. The patients randomly received (concealed allocation assignment) oral nitrofurantoin, 100 mg three times daily for five days, or a single 3-g dose of oral fosfomycin. Although patients were directly aware of treatment group assignment (open-label), individuals masked to treatment group assignment assessed all outcomes, including the primary outcome of clinical resolution of all symptoms and signs of UTI without prior failure. Complete follow-up occurred for 92% of patients at 28 days.

Using intention-to-treat and per-protocol analyses, significantly more patients in the nitrofurantoin group achieved clinical resolution than in the fosfomycin group (70% vs. 58%; number needed to treat = 8.1; 95% confidence interval, 4.8 to 25.9). Similarly, microbiologic resolution based on a negative urine culture occurred significantly more often in patients treated with nitrofurantoin. No significant group differences occurred in the development of pyelonephritis or urosepsis. Adverse events were mild and occurred similarly in both treatment groups.

Study design: Randomized controlled trial (single-blinded)

Funding source: Government

Allocation: Concealed

Setting: Outpatient (primary care)

Reference: HuttnerAKowalczykATurjemanAet alEffect of 5-day nitrofurantoin vs single-dose fosfomycin on clinical resolution of uncomplicated lower urinary tract infection in women: a randomized clinical trial. JAMA2018;319(17):1781–1789.