drugset / Trial / NCT04983901
PHASE II SINGLE-CENTER, RANDOMIZED, OPEN-LABEL, PROSPECTIVE, STUDY TO DETERMINE THE IMPACT OF SERIAL PROCALCITONIN
RandomizedParallel-groupOpen-labelTreatment
Summary
This phase II trial studies the effect of imipenem-relebactam in treating patients with cancer who have a fever due to low white blood cell counts (febrile neutropenia). In this study, imipenem-relebactam will be compared to the standard-of-care treatment (cefepime, meropenem, or piperacillin/tazobactam) for the treatment of febrile neutropenia. Imipenem-relebactam is used to treat infections. Giving imipenem-relebactam may help to control febrile neutropenia in patients with cancer.
Timeline
- Start
- 2021-09-14
- Primary completion
- 2023-10-06
- Completion
- 2023-10-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Amoxicillin | Other / unclassified | — | Intravenous |
| Comparator | Cefepime | Small molecule | — | Intravenous |
| Subject | Imipenem/Cilastatin/Relebactam | Unknown | — | Intravenous |
| Comparator | Meropenem | Small molecule | — | Intravenous |
| Background | Daptomycin | Other / unclassified | — | Intravenous |
| Background | Linezolid | Other / unclassified | — | Intravenous |
| Background | Vancomycin | Other / unclassified | — | Intravenous |