CERTAIN-1
Trial question
What is the role of cefepime/taniborbactam in patients with complicated UTI?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
53.0% female
47.0% male
N = 436
436 patients (230 female, 206 male).
Inclusion criteria: hospitalized adult patients with complicated UTI, including acute pyelonephritis.
Key exclusion criteria: received antibacterial drug therapy for complicated UTI for > 24 hours before randomization; infection with a meropenem-resistant pathogen; warranted nontrial systemic antibacterial therapy; prostatitis; perinephric or renal abscess; severe hepatic impairment; hypersensitivity to any β-lactam antibiotic; renal transplantation.
Interventions
N=293 cefepime/taniborbactam (at a dose of 2 g cefepime and 0.5 g of taniborbactam IV over a 2-hour period every 8 hours plus meropenem placebo for 7 days).
N=143 meropenem (at a dose of 1 g meropenem IV over a 30-minute period every 8 hours plus cefepime-taniborbactam placebo for 7 days).
Primary outcome
Rate of microbiologic and clinical success at test of cure on trial days 19-23
70.6%
58%
70.6 %
52.9 %
35.3 %
17.6 %
0.0 %
Cefepime/taniborbactam
Meropenem
Significant
increase ▲
NNT = 7
Significant increase in the rate of microbiologic and clinical success at test of cure on trial days 19-23 (70.6% vs. 58%; AD 12.6%, 95% CI 3.1 to 22.2).
Secondary outcomes
No significant difference in microbiologic and clinical success at end of treatment (89.1% vs. 86%; AD 3.1%, 95% CI -3.2 to 10.4).
Significant increase in microbiologic and clinical success at late follow-up (63.8% vs. 51.7%; AD 12.1%, 95% CI 2.2 to 21.9).
Significant increase in clinical success at late follow-up (81.2% vs. 71.3%; AD 9.9%, 95% CI 1.5 to 18.8).
Safety outcomes
No significant difference in serious adverse events.
Conclusion
In hospitalized adult patients with complicated UTI, including acute pyelonephritis, cefepime/taniborbactam was superior to meropenem with respect to the rate of microbiologic and clinical success at test of cure on trial days 19-23.
Reference
Florian M Wagenlehner, Leanne B Gasink, Paul C McGovern et al. Cefepime-Taniborbactam in Complicated Urinary Tract Infection. N Engl J Med. 2024 Feb 15;390(7):611-622.
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