ArticleClinical infectious diseases : an official publication of the Infectious Diseases Society of America2025
Pivmecillinam for Treatment of Uncomplicated Urinary Tract Infection: New Efficacy Analysis.
Article in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
1 citing paper in PubMed.
- From Pandemic to Resistance: Addressing Multidrug-Resistant Urinary Tract Infections in the Balkans.Antibiotics (Basel, Switzerland) · 2025Review
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Authors and funding
9 authors.
Funding
Abstract
backgroundIn April 2024-over 40 years after its first approval in Europe-pivmecillinam received approval from the United States Food and Drug Administration (FDA) for the treatment of uncomplicated urinary tract infection (uUTI) in women aged ≥18 years, caused by susceptible isolates of Escherichia coli, Proteus mirabilis, and Staphylococcus saprophyticus. Herein, we describe the reanalysis from previously published clinical trials, conducted in accordance with current FDA efficacy criteria, which formed the basis for this regulatory approval.
methodsOf 14 studies reviewed, 3 randomized, controlled trials offered suitable subject-level data from patients with uUTI treated with 185 mg pivmecillinam 3 times daily for 3-7 days. Efficacy endpoints for reanalysis were rates of overall (composite clinical and microbiological), clinical, and microbiological response in the microbiological intention-to-treat population (urine culture ≥105 colony-forming units/mL; ≤2 microorganism species; no baseline pathogen nonsusceptible to active comparator).
resultsAcross the 3 primary studies, overall success rates with pivmecillinam at test of cure (Days 7-15) were 62.0%-71.7% (clinical success, 63.5%-82.7%; microbiological success, 74.3%-86.9%). Overall success was higher for pivmecillinam than for placebo (95% confidence interval for the difference, 41.2-62.0) or ibuprofen (31.2-56.5) and similar to cephalexin (-15.6 to 7.4). Response to pivmecillinam was demonstrated in uUTIs caused by Enterobacterales, including E. coli, P. mirabilis, and Klebsiella pneumoniae, as well as gram-positive S. saprophyticus.
conclusionsThis reanalysis of randomized, controlled trial data confirmed the efficacy of oral pivmecillinam in uUTI and was used to support its recent approval in the United States.
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