drugset / Trial / NCT02149329
Short Versus Extended Antibiotic Treatment With a Carbapenem for High-risk Febrile Neutropenia in Hematology Patients With FUO
Phase 4
Completed
276 enrolled
Amsterdam UMC, location VUmc
Fonds NutsOhra · collabZonMw: The Netherlands Organisation for Health Research and Development · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
A multicenter open-label non-inferiority randomized clinical trial comparing the safety (non-inferiority) of short antibiotic treatment (72 hours) with an anti-pseudomonal carbapenem with regard to treatment failure in comparison with extended treatment (at least 9 days) of high-risk febrile neutropenia in hematology patients receiving standard antimicrobial prophylaxis.
Timeline
- Start
- 2014-12
- Primary completion
- 2019-08-05
- Completion
- 2019-08-05
Outcome
Met primary endpoint
paper adjusted risk difference [ARD] 4·0% [90% CI -1·7% to 9·7%]; p=0·25). PMID 35691326 ↗
paper Early discontinuation of carbapenem treatment in patients with febrile neutropenia of unknown origin does not result in increased treatment failure. PMID 35691326 ↗
Publications
- de Jonge NA, Janssen JJWM, Ypma P, Herbers AHE, de Kreuk A, Vasmel W, van den Ouweland JMW, Beeker A, Visser O, Zweegman S, Blijlevens NMA, van Agtmael MA, Sikkens JJ. Mucositis-associated bloodstream infections in adult haematology patients with fever during neutropenia: risk factors and the impact of mucositis severity. Support Care Cancer. 2024 Aug 8;32(9):579. doi: 10.1007/s00520-024-08776-w.
- de Jonge NA, Sikkens JJ, Zweegman S, Beeker A, Ypma P, Herbers AH, Vasmel W, de Kreuk A, Coenen JLLM, Lissenberg-Witte B, Kramer MHH, van Agtmael MA, Janssen JJWM. Short versus extended treatment with a carbapenem in patients with high-risk fever of unknown origin during neutropenia: a non-inferiority, open-label, multicentre, randomised trial. Lancet Haematol. 2022 Aug;9(8):e563-e572. doi: 10.1016/S2352-3026(22)00145-4. Epub 2022 Jun 9.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Imipenem-Cilastatin | Unknown | 500 mg | Intravenous |
| Subject | Meropenem | Small molecule | 1000 mg | Intravenous |