Nitrofurantoin vs. fosfomycin in uncomplicated UTI
Trial question
What is the effect of 5-day nitrofurantoin in female patients with uncomplicated UTI?
Study design
Multi-center
Open label
RCT
Population
513 female patients.
Inclusion criteria: female patients with uncomplicated UTI.
Key exclusion criteria: pregnancy and lactation, suspected upper UTI, antibiotic use or any symptoms consistent with UTI in the preceding 4 weeks, indwelling catheter, immunosuppression, ongoing chemotherapy or radiation therapy.
Interventions
N=255 oral nitrofurantoin (100 mg PO TID for 5 days).
N=258 oral fosfomycin (single 3 g oral dose).
Primary outcome
Clinical resolution at 28 days after therapy completion
70%
58%
70.0 %
52.5 %
35.0 %
17.5 %
0.0 %
Oral
nitrofurantoin
Oral
fosfomycin
Significant
increase ▲
NNT = 8
Significant increase in clinical resolution at 28 days after therapy completion (70% vs. 58%; ARD 12, 95% CI 4 to 21).
Secondary outcomes
Significant increase in microbiologic resolution (74% vs. 63%; ARD 11, 95% CI 1 to 20).
Significant increase in clinical response at 14 days (75% vs. 66%; ARR 9, 95% CI 1 to 17).
Safety outcomes
No significant differences in adverse events, including nausea (3% vs. 2%) and diarrhea (1% vs. 1%).
Conclusion
In female patients with uncomplicated UTI, oral nitrofurantoin was superior to oral fosfomycin with respect to clinical resolution at 28 days after therapy completion.
Reference
Huttner A, Kowalczyk A, Turjeman A et al. Effect of 5-Day Nitrofurantoin vs Single-Dose Fosfomycin on Clinical Resolution of Uncomplicated Lower Urinary Tract Infection in Women: A Randomized Clinical Trial. JAMA. 2018 May 1;319(17):1781-1789.
Open reference URL