New antibiotic cocktail aims to beat infections in cancer patients
NCT ID NCT04983901
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This phase II trial tested whether a newer antibiotic combination (imipenem-relebactam) works better than standard antibiotics for treating fever caused by low white blood cell counts in cancer patients. About 100 adults with cancer or who had a stem cell transplant took part. The study compared how well each treatment controlled the infection during their hospital stay.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Imipenem-relebactam (antibiotic combination)
- What this could lead to
- If successful, this could offer a more effective antibiotic option for cancer patients with fever and low white blood cell counts, potentially reducing treatment failures.
- What could go wrong
- This is a small, early-phase trial (100 participants) at a single center. Results may not apply broadly, and the drug may not outperform current standard treatments.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
100 people
The number who actually took part.
- Started
-
Sep 2021
- Finished
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Oct 2023
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
M D Anderson Cancer Center
Houston, Texas, 77030, United States
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