PHASE II SINGLE-CENTER, RANDOMIZED, OPEN-LABEL, PROSPECTIVE, STUDY TO DETERMINE THE IMPACT OF SER⦠(NCT04983901) | Clinical Trial Compass
CompletedPhase 2
PHASE II SINGLE-CENTER, RANDOMIZED, OPEN-LABEL, PROSPECTIVE, STUDY TO DETERMINE THE IMPACT OF SERIAL PROCALCITONIN
United States100 participantsStarted 2021-09-14
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Has provided written informed consent, and has the willingness and ability to comply with all study procedures
* \>= 18 years old
* Patients with neutropenic fever who have existing malignancy or have undergone hematopoietic stem cell transplantation
* Neutropenic fever is defined as the presence of neutropenia defined by:
* Absolute neutrophil count (ANC) \< 500 cells/mm3 or has an ANC that is expected to decrease to \< 500 cells/mm\^3 within 48 hours of trial entry and fever defined as:
* Single oral temperature measurement of \> 100.4 degree F (38.0 degree C).
* Requires hospitalization for IV empiric antibiotic therapy
* If female:
* Not breastfeeding
* Agrees to not attempt to become pregnant during the study. Is surgically sterile or at least 2-years postmenopausal, or if of childbearing potential, has negative screening serum or urine pregnancy test within 5 days
* If of childbearing potential (including being \< 2 years postmenopausal), is willing to practice sexual abstinence or use an effective dual form of contraception with her partner (eg, 2 barrier methods, barrier method plus hormonal method) during treatment and up 28 days post treatment
Exclusion Criteria:
* History of any hypersensitivity or allergic reaction to any carbapenem
* Fever suspected to be caused by a noninfectious cause (eg, fever related to drug or blood product administration)
* Confirmed fungal infection (eg, Pneumocystis jirovecii etiology in patients with pā¦
What they're measuring
1
Clinical Outcome in the MITT Analysis Set at EOIV.
Timeframe: Within 72 hours after administration of the last dose of inpatient IV study drug.