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Five-day nitrofurantoin superior to single-dose fosfomycin for women with uncomplicated UTI
Clinical Question
Is a 5-day course of nitrofurantoin as effective as single-dose fosfomycin in the treatment of women with uncomplicated lower urinary tract infection?
Bottom line
A 5-day course of nitrofurantoin is significantly more likely than single-dose fosfomycin to achieve both clinical and microbiologic resolution of uncomplicated lower urinary tract infections (UTIs) in otherwise healthy adult women. 1b-
Reference
Study design: Randomized controlled trial (single-blinded)
Funding: Government
Setting: Outpatient (primary care)
Synopsis
These investigators identified women,18 years and older, who presented with at least 1 symptom of acute lower UTI, including dysuria, urgency, frequency, or suprapubic tenderness, and a urine dipstick result positive for either nitrites or leukocyte esterase. Exclusion criteria included pregnancy, lactation, suspected upper UTI, antibiotic treatment for a UTI in the previous 4 weeks, indwelling urinary catheter, or immunosuppression. The patients randomly received (concealed allocation assignment) either oral nitrofurantoin, 100 mg 3 times daily for 5 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 both 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% CI 4.8 - 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.
Reviewer
David C. Slawson, MD
Professor and Vice Chair of Family Medicine for Education and Scholarship
Atrium Health
Professor of Family Medicine, UNC Chapel Hill
Charlotte, NC
Comments
Most clinicians use MacroBID--too bad that wasn't the comparator.
We were doing these studies 30+ years ago. Is the ongoing need for them related to changing microbial ecology? Interesting that nitrofurantoin is one of our oldest antimicrobials. Also interesting that it has never been very popular. Maybe this is why it is still effective.
This was a clinical question I've had for a while. Glad to see that I was managing patients appropriately.
Dosage of nitrofurantoin
This study used tid rather than the usual dose of bid nitrofurantoin which then questions the validity of the results in our practices
Criteria for dx and age
I wonder about dipstick and symptoms as the dx criteria in all adult women. How many post menopausal and elderly women were included?
With the many treatment options available today to treat an uncomplicated UTI, a TID dosage is cumbersome and likely to interfere with compliance. On the other hand, I have generally harbored concerns that a one-time oral dose may well lead to bacterial eradication, but may leave an inflamed and compromised bladder surface, leaving it more susceptible to re-infection. RM
This is old news. The recommended length of treatment for an uncomplicated bacterial cystitis in a healthy woman had been 10 days, then 7 days, then 5 days, then 3 days. Years ago people tried one big dose of nitrofurantoin or sulfa-trim and there were too many treatment failures. I prescribe 4 days of nitrofurantoin and it works.
My only problem with this is that I have had 3 patients have serious reactions to Nitrofurantoin in the last 2 years. One patient ended up in acute kidney failure and had on-going respiratory problems because we did not stop the nitrofurantoin immediately.