PHASE II SINGLE-CENTER, RANDOMIZED, OPEN-LABEL, PROSPECTIVE, STUDY TO DETERMINE THE IMPACT OF SERIAL PROCALCITONIN

Completed · Phase 2

Conditions studied: Hematopoietic and Lymphoid Cell Neoplasm, Malignant Solid Neoplasm

In brief

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.

Key facts

Study ID: NCT04983901
Run by: M.D. Anderson Cancer Center
People needed: 100
Starts: 2021-09-14
Expected to finish: 2023-10-06
Last updated by the study team: 2026-04-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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 pneumonia) that justifies adding additional empiric antimicrobial therapy (eg, antifungals)
Confirmed viral infection that justifies adding additional empiric antiviral therapy (eg, ganciclovir, foscarnet)
Evidence of significant hepatic impairment (any of the following):
Known acute viral hepatitis
Alanine aminotransferase (ALT) level > 5 times the upper limit of normal (x upper limit of normal [ULN]). Total bilirubin > 3 x ULN unless isolated hyperbilirubinemia is directly related to the acute infection or due to known Gilbert disease
Manifestations of end-stage liver disease, such as ascites or hepatic encephalopathy
Known to be human immunodeficiency virus positive
Severely impaired renal function, defined as creatinine clearance (CrCl) =< 30 mL/min estimated by the Cockcroft-Gault formula
Expected requirement for hemodialysis while on study therapy
Received > 36 hours of IV antibacterial therapy (with study drugs) within 72 hours of the initiation of inpatient IV study drug for treatment of suspected infection. Antibiotic prophylaxis and oral antibiotics is allowed. Prophylactic use of antiviral or antifungal medication is permitted
Past or current history of epilepsy or seizure disorder; exception: well-documented febrile seizure of childhood
Evidence of immediately life-threatening disease, progressively fatal disease, or life expectancy of 3 months or less (eg, moribund or with shock unresponsive to fluid replacement)
Unable or unwilling to adhere to the study-specified procedures and restrictions
Any condition that would make the patient, in the opinion of the Investigator, unsuitable for the study (eg, would place a patient at risk or compromise the quality of the data
Participation in any other ongoing imipenem-relebactam trial

Where it is running

M D Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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