CompletedPhase 3

Ceftobiprole in the Treatment of Patients With Staphylococcus Aureus Bacteremia

United States390 participantsStarted 2018-08-26

Plain-language summary

The purpose of this study was to compare the efficacy and safety of ceftobiprole medocaril versus a comparator in the treatment of patients with complicated Staphylococcus aureus bacteremia (SAB).

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. fever (e.g.≥ 38 °C/100.4 °F measured orally)
✓. white blood cell count \> 10,000 or \< 4,000 cells/µL, or \> 10% immature neutrophils (bands)
✓. tachycardia (heart rate \> 90 bpm)
✓. hypotension (systolic blood pressure \< 90 mmHg)
✓. SAB in patients undergoing chronic intermittent hemodialysis or peritoneal dialysis
✓. Persistent SAB
✓. Definite native-valve right-sided infective endocarditis by Modified Duke's Criteria
✓. Other forms of complicated SAB

What they're measuring

Number of Patients With or Without Overall Success at the Post-treatment Evaluation (PTE) Visit

Timeframe: PTE visit on Day 70 (± 5 days) post-randomization

Trial details

NCT IDNCT03138733

SponsorBasilea Pharmaceutica

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-03-11

Results submitted2023-03-06

View on ClinicalTrials.gov More Staphylococcus Aureus Bacteremia trials