Ciprofloxacin for 7 vs. 14 days in pyelonephritis
Trial question
Is ciprofloxacin for 7 days noninferior to 14 days ciprofloxacin in female patients with acute pyelonephritis?
Study design
Multi-center
Double blinded
RCT
Population
248 female patients
Inclusion criteria: non-pregnant female patients with acute pyelonephritis
Key exclusion criteria: pregnancy or lactation; inadequate contraception for women of childbearing age; known hypersensitivity to fluoroquinolones; systemic antibiotic treatment within the preceding 72 h; presence of an indwelling urinary catheter or clean intermittent catheterization of the bladder
Interventions
N=126 treatment with ciprofloxacin for 7 days (500 mg BID for 7 days followed by placebo for next 7 days)
N=122 treatment with ciprofloxacin for 14 days (500 mg BID for 14 days)
Primary outcome
Short-term clinical cure
97
96
97.0 %
72.8 %
48.5 %
24.3 %
0.0 %
Treatment with ciprofloxacin for 7
days
Treatment with ciprofloxacin for 14
days
Difference not exceeding
non-inferiority
margin ✓
Difference not exceeding non-inferiority margin in short-term clinical cure (97% vs. 96%; ARD -0.9, 90% CI -6.5 to 4.8)
Secondary outcomes
Significant increase in cumulative efficacy at long-term follow-up (93% vs. 93%; )
Safety outcomes
No significant difference in adverse events (5% vs. 6%).
Significant differences in mucosal candida infection (0 vs. 5, p = 0.036).
Conclusion
In non-pregnant female patients with acute pyelonephritis, treatment with ciprofloxacin for 7 days were noninferior to treatment with ciprofloxacin for 14 days with respect to a short-term clinical cure.
Reference
Sandberg T, Skoog G, Hermansson AB et al. Ciprofloxacin for 7 days versus 14 days in women with acute pyelonephritis: a randomised, open-label and double-blind, placebo-controlled, non-inferiority trial. Lancet. 2012 Aug 4;380(9840):484-90.
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