Trial reportPloS one2025
Ceftobiprole versus ceftriaxone ± linezolid in Community-Acquired Bacterial Pneumonia (CABP): Re-analysis of a randomized, phase 3 study using 2020 FDA guidance.
Trial report in PloS one, 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.
Corrections and comments
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Authors and funding
7 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundCeftobiprole is an advanced-generation cephalosporin with activity against methicillin-resistant Staphylococcus aureus, resistant pneumococci, and Enterobacterales. In a Phase 3 study in community-acquired bacterial pneumonia (CABP) performed prior to the current US Food and Drug Administration (FDA) guidance, clinical cure at the test-of-cure visit (TOC) was the primary endpoint. We present a re-analysis using early clinical success as the primary endpoint per the 2020 FDA CABP Guidance.
methodsIn this multicenter, double-blind study, patients with CABP requiring hospitalization were randomized to intravenous ceftobiprole (500 mg q8h) or ceftriaxone (2000 mg q24h) ± linezolid (600 mg q12h) for 3-14 days. The primary endpoint was clinical success at Day 3 (improvement in ≥2 symptoms of chest pain, cough, productive sputum, difficulty breathing). A 12.5% non-inferiority margin was used.
resultsOf the original 638 patients, 618 (97%) had ≥ 2 symptoms and were included in the Day 3 Intent-to-Treat (ITT) population for the re-analysis. The Day 3 modified ITT population consisted of 187 patients (29%) meeting additional FDA Guidance including Patient Outcomes Research Team (PORT) classification ≥III. Ceftobiprole was non-inferior to ceftriaxone for clinical success for Day 3 ITT (71.0% vs 71.1%) and Day 3 modified ITT (71.1% vs 66.7%) populations. The 28-day all-cause mortality was 1.6% (ceftobiprole) vs 2.6% (ceftriaxone) in the Day 3 ITT population and 2.1% vs 7.8% in the Day 3 modified ITT population.
conclusionCeftobiprole was non-inferior to ceftriaxone ± linezolid for clinical success at Day 3 according to the current 2020 FDA CABP Guidance.
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