SURE 2
Trial question
Is sulopenem noninferior to ertapenem in patients with complicated UTIs, including pyelonephritis?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
59.0% female
41.0% male
N = 884
884 patients (521 female, 363 male).
Inclusion criteria: hospitalized adult patients with pyuria, bacteriuria, and signs and symptoms of complicated UTI.
Key exclusion criteria: presence of chronic indwelling catheters, infections likely due to complete obstruction, emphysematous pyelonephritis, renal or perinephric abscess, or otherwise expected to require surgical intervention to achieve cure; ileal loops or vesicoureteral reflux; history of renal transplantation.
Interventions
N=444 sulopenem (intravenous sulopenem 1,000 mg once daily followed by oral sulopenem etzadroxil/probenecid 500/500 mg BID for 7-10 days).
N=440 ertapenem (intravenous ertapenem 1,000 mg once daily followed by oral ciprofloxacin 500 mg or amoxicillin/clavulanate 875/125 mg BID for 7-10 days).
Primary outcome
Overall response at test of cure
67.8%
73.9%
73.9 %
55.4 %
37.0 %
18.5 %
0.0 %
Sulopenem
Ertapenem
Difference exceeding
non-inferiority
margin ✗
Difference exceeding non-inferiority margin in overall response at test of cure (67.8% vs. 73.9%; ARD -6.1, 95% CI -12 to -0.1).
Secondary outcomes
Significant decrease in microbiologic response per patient at test of cure (71.2% vs. 78%; ARD -6.8, 95% CI -12.5 to -1.1).
No significant difference in overall success at end of treatment (86.7% vs. 88.9%; ARD -2.2, 95% CI -6.5 to 2.2).
No significant difference in clinical response at test of cure in the intention-to-treat population (88.2% vs. 86.4%; AD 1.8%, 95% CI -1.6 to 5.3).
Safety outcomes
No significant difference in adverse events.
Conclusion
In hospitalized adult patients with pyuria, bacteriuria, and signs and symptoms of complicated UTI, sulopenem was not noninferior to ertapenem with respect to overall response at test of cure.
Reference
Michael W Dunne, Steven I Aronin, Anita F Das et al. Sulopenem for the Treatment of Complicated Urinary Tract Infections Including Pyelonephritis: A Phase 3, Randomized Trial. Clin Infect Dis. 2023 Jan 6;76(1):78-88.
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