The results, published in the New England Journal of Medicine, open the way for a simplified treatment for a condition that affects 3 million people in the United States each year. As antibiotic resistance has grown, so has the need for hospitalization because so many infections involve resistant strains.
"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," write Dr. Angela K. Talley of Spero Therapeutics in Cambridge, Massachusetts, and colleagues.
The phase-3 double-blind noninferiority trial was done with 868 patients at 95 centers in Europe, South Africa and the United States. Spero Therapeutics, which paid for the study, announced the findings in September 2020.
Both treatments were usually given for seven to 10 days.
The overall response rates were 58.8% among tebipenem pivoxil hydrobromide recipients versus 61.6% among ertapenem patients. The weighted difference (-3.3 percentage points; 95% CI, -9.7 to 3.2) fell within the noninferiority margin of 12.5%.
Clinical cure rates were 93.1% and 93.6% respectively in the intention-to-treat population. The rates of sustained clinical cure about 25 days after the start of treatment were 88.6% and 90.0%.
Mild diarrhea, seen in fewer than 6% of patients, and headache, reported in 3.8% of volunteers in both groups, were the most common adverse events in both groups. The rates of all adverse events were 25.7% with the oral drug and 25.6% with the intravenous therapy.
SOURCE: https://bit.ly/3qXrSYV The New England Journal of Medicine, online April 7, 2022
By Reuters Staff
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