drugset / Trial / NCT07318584
Cefotetan Therapy for Escherichia Coli Infections
RandomizedParallel-groupOpen-labelTreatment
Summary
This pilot study will compare clinical outcomes among patients treated with cefotetan versus standard of care antibiotics for bacteremia or genitourinary infections caused by E. coli. It will also measure cefotetan minimum inhibitory concentration (MIC) distributions and cefotetan trough serum concentrations.
Timeline
- Start
- 2026-03
- Primary completion
- 2028-02
- Completion
- 2028-08
Publications
- Background Tamma PD, Heil EL, Justo JA, Mathers AJ, Satlin MJ, Bonomo RA. Infectious Diseases Society of America 2024 Guidance on the Treatment of Antimicrobial-Resistant Gram-Negative Infections. Clin Infect Dis. 2024 Aug 7:ciae403. doi: 10.1093/cid/ciae403. Online ahead of print.
- Background Harris PNA, Tambyah PA, Lye DC, Mo Y, Lee TH, Yilmaz M, Alenazi TH, Arabi Y, Falcone M, Bassetti M, Righi E, Rogers BA, Kanj S, Bhally H, Iredell J, Mendelson M, Boyles TH, Looke D, Miyakis S, Walls G, Al Khamis M, Zikri A, Crowe A, Ingram P, Daneman N, Griffin P, Athan E, Lorenc P, Baker P, Roberts L, Beatson SA, Peleg AY, Harris-Brown T, Paterson DL; MERINO Trial Investigators and the Australasian Society for Infectious Disease Clinical Research Network (ASID-CRN). Effect of Piperacillin-Tazobactam vs Meropenem on 30-Day Mortality for Patients With E coli or Klebsiella pneumoniae Bloodstream Infection and Ceftriaxone Resistance: A Randomized Clinical Trial. JAMA. 2018 Sep 11;320(10):984-994. doi: 10.1001/jama.2018.12163.
- Background Stewart AG, Cottrell K, Henderson A, Vemuri K, Bauer MJ, Paterson DL, Harris PNA. In Vitro Activity of Cefotetan against ESBL-Producing Escherichia coli and Klebsiella pneumoniae Bloodstream Isolates from the MERINO Trial. Microbiol Spectr. 2021 Sep 3;9(1):e0022621. doi: 10.1128/Spectrum.00226-21. Epub 2021 Jul 7.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Amoxicillin | Other / unclassified | — | — |
| Comparator | Ampicillin | Unknown | — | — |
| Comparator | Cefepime | Small molecule | — | — |
| Subject | Cefotetan | Small molecule | 2 g | Intravenous |
| Comparator | Ceftazidime | Small molecule | — | — |
| Comparator | Ceftriaxone | Other / unclassified | — | — |
| Comparator | Ertapenem | Small molecule | — | — |
| Comparator | Meropenem | Small molecule | — | — |