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Home » News » Urology » Urinary Tract Infections
(UTI)
April 5, 2022
Oral Tebipenem as
Effective as Ertapenem
for Complicated UTI,
Pyelonephritis
Natasha Persaud
Oral tebipenem pivoxil hydrobromide (HBr), a
carbapenem, is as effective as intravenous (IV)
ertapenem in treating complicated urinary tract
infection (cUTI) and pyelonephritis in appropriately
selected hospitalized patients, according to new study
findings published in The New England Journal of
Medicine.
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“Tebipenem has broad-spectrum activity against
multidrug-resistant gram-negative pathogens,
including fluoroquinolone-resistant and ESBLproducing Enterobacterales,” Angela K. Talley, MD, of
Spero Therapeutics, Cambridge, Massachusetts, and
colleagues explained.
In the international phase 3 ADAPT-PO trial
(ClinicalTrials.gov number, NCT03788967), the
investigators randomly assigned 868 hospitalized
patients diagnosed with cUTI (50.8%) or acute
pyelonephritis (49.2%) due to gram-negative bacteria
susceptible to a carbapenem to receive oral tebipenem
HBr (600 mg every 8 hours) or IV ertapenem (1 g every
24 hours). Patients with a creatinine clearance of 31 to
50 mL/min received 300 mg of tebipenem HBr or
placebo every 8 hours. Patients with a creatinine
clearance of 30 mL/min or less were excluded.
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More than 90% of the baseline pathogens were
Enterobacterales, primarily Escherichia coli, Klebsiella
pneumoniae, Enterobacter cloacae, and Proteus mirabilis.
Of the cohort, 11.5% had bacteremia and 19.7% had
systemic inflammatory response syndrome.
After a 7-to-10-day course of antibiotic therapy (up to
14 days for patients with bacteremia), an overall
response comprising clinical cure and microbiologic
response occurred in 58.8% of the tebipenem HBr
group and 61.6% of the ertapenem group – a 3.3%
difference that was well within the noninferiority
margin of 12.5%, Dr Talley and colleagues reported.
Clinical cure at a test-of-cure visit on day 19 was
observed in 93.1% and 93.6%, respectively.
Microbiologic response occurred in 59.5% and 63.5%,
respectively.
Adverse events (AEs) occurred in 25.7% of the
tebipenem HBr group and 25.6% of the ertapenem
group. The most common AEs were mild diarrhea,
nausea, and headache. Drug-related AEs occurred in
9.3% and 6.1%, respectively. C. difficile-associated AEs
occurred in 3 patients receiving ertapenem, but no
patients receiving tebipenem HBr.
Dr Talley’s team concluded, “In the absence of other
effective oral agents, tebipenem pivoxil hydrobromide
may provide an option for the treatment of
complicated urinary tract infection and acute
pyelonephritis due to antibiotic-resistant
uropathogens.”
Disclosure: This research was supported by Spero
Therapeutics. Please see the original reference for a full list
of disclosures.
Reference
Eckburg PB, Muir L, Critchley IA, et al. Oral tebipenem
pivoxil hydrobromide in complicated urinary tract
infection. N Engl J Med. 386:1327-1338.
doi:10.1056/NEJMoa2105462
TOPICS:
MEDICATIONS
URINARY TRACT INFECTION
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