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Study of Cefiderocol/Xeruborbactam for Bacterial Infections in People with Kidney Problems

This study is testing a combination antibiotic called Cefiderocol/Xeruborbactam given through an IV (into a vein). It aims to understand how safe this drug is and how your body processes it if you have kidney impairment, compared to people with normal kidney function. The study is looking for 40 adults aged 18 to 80 who have bacterial infections. The main goals are to track any side effects and measure how much of the drug is in your blood over about 11-22 days. The results will help doctors know the best way to give this antibiotic to patients with kidney problems. This is an open-label study, meaning you and the study team will know which treatment you are receiving.

Study design
This is a Phase 1, open-label study involving 40 participants. It is designed to compare the effects of a single dose of the drug in people with different levels of kidney function.
What's involved
You would need to be able to understand the study and sign a consent form. The study will involve tests and examinations over approximately 11-22 days.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for safety and drug levels for about 11-22 days after receiving the treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07104162

A Study to Investigate Safety and Pharmacokinetics of Intravenous Cefiderocol/Xeruborbactam in Participants With Renal Impairment

Recruiting
PHASE1Ages 18–80InterventionalTreatment
Qpex Biopharma, Inc.
~40 participants
Updated 2025-11-25 on ClinicalTrials.gov
What's tested:Cefiderocol/Xeruborbactam

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of treatment-emergent adverse events (TEAEs) by participant and by group
Measured over 11-22 days (+/- 2)
+6 more outcomes measured

Conditions

Bacterial Infections

Explore related trials

Bacterial Infection

Where it's being run

2 sites across 1 states
Florida2

Study leadership

  • Thomas Marbury, MD · PRINCIPAL_INVESTIGATOR · Orlando Clinical Research Center
  • Richard Preston, MD · PRINCIPAL_INVESTIGATOR · University of Miami

Who to contact

Grigor Mamikonyan, PharmD,PhD
[email protected]
(954) 404-8068 · ext. 303
Email the study team

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Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

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Eligibility criteria

Inclusion

Able to understand the study conduct and tasks required of the participants, sign the informed consent form and willing to cooperate with all tests and examinations required by the protocol.
Aged 18 to 80 years, inclusive, at the time of consent.
If male, agrees to be sexually abstinent or agrees to use 2 approved methods of contraception (refer to Inclusion Criterion 4) when engaging in heterosexual activity from Day -1 through 90 days following the last administration of the study intervention, and to not donate sperm during this same period of time. If the sexual partner is surgically sterile, contraception is not necessary.
If female of childbearing potential, must either be sexually abstinent for 14 days prior to Day -1 and remain so through 30 days following dosing of the study intervention or have been using (or agree to use) 2 acceptable methods of birth control when engaging in heterosexual activity
If female of childbearing potential, must agree not to donate eggs (ova, oocytes) for the purpose of reproduction from Day -1 through 30 days following the last administration of the study intervention.
If female of non-childbearing potential, must either be postmenopausal (defined as 12 months spontaneous amenorrhea) with serum follicle stimulating hormone (FSH) level in the laboratory-defined postmenopausal range or have undergone sterilization procedures at least 6 months prior to Day -1; documentation of sterilization procedure must be obtained
Has a BMI ≥ 18.5 kg/m2 and ≤ 45 kg/m2, inclusive.
Has negative test results for hepatitis B surface antigen (HBsAg), anti-Hepatitis C virus (HCV) antibody, anti-human immunodeficiency virus (HIV) antibody, and SARS-CoV-2.
Has an eGFR ≥ 90 mL/min calculated using the 2021 CKD-EPI equation adjusted for the participant's BSA at screening
Meets matching criteria for age, BMI, and gender of pooled renally impaired participants as defined in the protocol.
Stable mild to severe renal impairment, as assessed by eGFR calculated using the 2021 CKD-EPI equation adjusted for the participant's BSA at screening
Is on a stable medication regimen
Receiving stable IHD at least 3 times a week for at least 3 months, using an arteriovenous fistula, graft, or catheter
Is on a stable medication regimen

Exclusion

Has unstable or new medical condition(s)
Has had surgery under general anesthesia within the past 3 months prior to Day -1, determined by the investigator to be clinically relevant.
Documented hypersensitivity reaction or anaphylaxis to any medication.
History of seizures, convulsions
Current evidence or history of malignancy
If female, is pregnant, lactating, or has a positive pregnancy test at screening or Day -1.
Received any investigational drug within 30 days or 5 half-lives, whichever is longer, of Day -1 for the current clinical study.
Blood donation or significant blood loss (ie, \> 500 mL) within 56 days prior to Day -1.
Plasma or platelet donation within 14 days prior to Day -1.
Any acute illness requiring antibiotic drug therapy within 30 days prior to Day -1 or a febrile illness within 7 days prior to Day -1.
Vigorous exercise from 72 hours prior to Day -1 through the final FU/EOS Visit.
Positive drug test at the Screening Visit or Day -1
Positive alcohol test at screening or Day -1 and/or recent history (ie, within 6 months prior to Day -1) of excessive alcohol intake.
Concurrent use of medications known to affect the elimination of serum creatinine and competitors of renal tubular secretion
Employees of the investigative site involved in this study.
Unable or unwilling to adhere to the study-specified procedures and restrictions.
QTcF interval \> 500 msec, previous history or family history of prolonged QT syndrome at screening or Day -1.
Use of products containing alcohol, caffeine, xanthine, or ephedrine within 24 hours prior to Day -1; use of alcohol 48 hours prior to Day -1; use of proton pump inhibitors (eg, omeprazole and pantoprazole) 7 days prior to Day -1, including both over-the-counter (OTC) and prescription drugs in these categories; or consumption of grapefruit/grapefruit juice, Seville oranges, pomelo, exotic citrus fruits or grapefruit hybrids or juices containing such products within 7 days prior to Day -1.
Has any clinically significant abnormalities in laboratory values at screening or Day -1, defined in the study protocol.
Abnormal and clinically significant findings on physical examination, medical history, serum chemistry, hematology, or urinalysis per Investigator discretion. Participants in the renal impairment group will have consideration for the degree of renal impairment and presence of comorbidities.
Has renal disease secondary to hepatic disease (hepatorenal syndrome)

What this trial measures

  • Incidence of treatment-emergent adverse events (TEAEs) by participant and by group11-22 days (+/- 2)

    Number of participants with treatment-emergent adverse events by severity and relationship to treatment

  • Number of participants with changes from baseline in safety parameters11-22 days (+/- 2)

    Number of participants with changes in safety parameters before and after dosing by subject and group

  • Maximum plasma concentration measurements by subject and by group (Cmax)11-22 days (+/- 2)

    Comparison will be performed between the groups for maximum plasma concentration (Cmax).

  • Time to maximum plasma concentration (Tmax)11-22 days (+/- 2)

    Comparison will be performed between the groups for time to maximum plasma concentration (Tmax)

  • Area under the plasma concentration versus time curve (AUC)11-22 days (+/- 2)

    Comparison will be performed between the groups for area under the plasma concentration versus time curve (AUC)

  • Cumulative amount of drug excreted as unchanged in the urine (Aeu)11-22 days (+/- 2)

    This parameter will not be estimated in Group 5

  • Cumulative amount of drug excreted as unchanged in the dialysate (Aed)11-22 days (+/- 2)

    This parameter will be estimated only in Group 5. Urine pharmacokinetic (PK) parameters will be calculated from urinary excretion and dialysate data.