Nitrofurantoin versus Ciprofloxacin for Empirical Treatment of Uncomplicated Urinary Tract Infection: A Randomized Comparative Study in the Era of Fluoroquinolone Resistance
Abstract
Urinary tract infections (UTIs) are a major global health concern, affecting approximately 150 million individuals annually. The empirical treatment of uncomplicated UTIs often involves antibiotics such as ciprofloxacin and nitrofurantoin. However, rising antimicrobial resistance, particularly ciprofloxacin resistance, poses a significant challenge. This randomized comparative study aimed to evaluate the efficacy and safety of nitrofurantoin versus ciprofloxacin in adult women with uncomplicated UTIs in a tertiary care setting in India. A total of 50 culture-confirmed patients were randomly allocated (1:1) using computer-generated random numbers in sealed opaque envelopes to receive either nitrofurantoin (Group I, n=25) or ciprofloxacin (Group II, n=25). Treatment duration was 7 days for acute and 14 days for recurrent UTIs. Primary endpoint was microbiological cure at test-of-cure (day 14–21). Secondary endpoints were clinical cure, adverse events, and recurrence at 28 days. Microbiological cure rates were significantly higher with nitrofurantoin (88% [22/25] vs. 76% [19/25], RR 1.16, 95% CI 0.98–1.37, p=0.016). Clinical cure rates were 92% versus 80%, respectively. Adverse events occurred in 20% of nitrofurantoin patients versus 44% of ciprofloxacin patients. At 28-day follow-up, recurrence rates were 4% (1/25) in the nitrofurantoin group versus 12% (3/25) in the ciprofloxacin group (p=0.609). Nitrofurantoin demonstrated superior bacteriological efficacy and tolerability.…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 150 participants or records.
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