Cefiderocol/Xeruborbactam for Bacterial Infection

Recruiting at 1 trial location

Overseen By Grigor Mamikonyan, PharmD,PhD

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Qpex Biopharma, Inc.

Must not be taking: Proton pump inhibitors

Disqualifiers: Unstable conditions, Seizures, Malignancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 day

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test the safety and metabolism of a new drug combination, cefiderocol/xeruborbactam, administered through an IV. It focuses on individuals with varying levels of kidney function, including those with normal kidney function. The goal is to understand how these conditions affect the drug's performance. Individuals with stable kidney issues or those undergoing regular dialysis might be suitable candidates for this trial. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in humans.

Do I have to stop taking my current medications for the trial?

The trial requires participants with renal impairment or on hemodialysis to be on a stable medication regimen, so you may not need to stop your current medications. However, certain medications that affect kidney function or are competitors of renal tubular secretion are not allowed.

Is there any evidence suggesting that Cefiderocol/Xeruborbactam is likely to be safe for humans?

Research shows that the safety of using cefiderocol with xeruborbactam in humans is still under investigation. Previous studies have examined these drugs both together and separately. Cefiderocol was generally well-tolerated, with some individuals experiencing mild side effects such as diarrhea or injection site reactions. Xeruborbactam is newer, so less is known about its side effects when combined with cefiderocol.

Since this trial is in an early phase, researchers are still collecting safety data. Early-phase trials typically mark the first time a treatment is tested in humans, meaning there is limited information about how well people tolerate the combination of cefiderocol and xeruborbactam. Participants in these trials assist researchers in understanding the treatment's safety. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard antibiotics for bacterial infections, Cefiderocol/Xeruborbactam is unique because it combines two powerful agents that target resistant bacteria. Cefiderocol acts like a trojan horse, using a novel mechanism to penetrate bacteria by hijacking their iron uptake system. Xeruborbactam enhances this action by inhibiting bacterial enzymes that usually break down antibiotics. Researchers are excited because this combination could be more effective against tough, drug-resistant infections that current treatments struggle to combat.

What evidence suggests that Cefiderocol/Xeruborbactam might be an effective treatment for bacterial infection?

Studies have shown that combining cefiderocol with xeruborbactam can inhibit the growth of certain bacteria, such as Enterobacterales, more effectively than cefiderocol alone. Cefiderocol enters bacterial cells by using the same pathways bacteria use to collect iron, essential for their growth. This method has proven effective against difficult-to-treat, drug-resistant bacteria. Early research suggests that this combination could be a strong option for combating tough bacterial infections. Participants in this trial will receive a single dose of the cefiderocol/xeruborbactam combination to further evaluate its effectiveness. ^{1 2 5 6 7}

Who Is on the Research Team?

Thomas Marbury, MD

Principal Investigator

Orlando Clinical Research Center

Richard Preston, MD

Principal Investigator

University of Miami

Are You a Good Fit for This Trial?

This trial is for individuals with varying degrees of kidney function, from normal to severely impaired, who have a bacterial infection. Participants must be adults and can't be pregnant or breastfeeding. They should not have any other significant medical conditions that could interfere with the study.

Inclusion Criteria

I am between 18 and 80 years old.

I agree to not have sex or use two forms of birth control.

Participants must have negative test results for specific infections

Exclusion Criteria

Participants must not have a history of seizures or convulsions

Participants must not have certain abnormalities in laboratory values

I do not have any new or worsening health conditions.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single dose of intravenous cefiderocol/xeruborbactam

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and pharmacokinetics after treatment

11-22 days

Multiple visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Cefiderocol/Xeruborbactam

Trial Overview The study is testing Cefiderocol/Xeruborbactam, an intravenous antibiotic combination. It's designed to see how the drug behaves in the body (pharmacokinetics) and its safety across different levels of kidney health in a single-dose format.

How Is the Trial Designed?

Group I: Open Label, Single Dose of IV Cefiderocol/Xeruborbactam Experimental Treatment 1 Intervention

Approximately 40 participants will be enrolled in total. Eight participants will be enrolled in each group (G) based on renal impairment (RI) determined by estimated glomerular function rate (eGFR) or need for intermittent hemodialysis (IHD) at screening: * G1: Mild RI (eGFR 60 \< 90 mL/min calculated using the 2021 Chronic Kidney Disease Epidemiology Collaboration equation \[CKP-EPI\]) adjusted for the participant's body surface \[BSA\]) * G2: Moderate RI (eGFR 30 to \< 60 mL/min calculated using the 2021 CKD-EPI equation adjusted for the participant's BSA) * G3: Severe RI (eGFR \< 30 mL/min calculated using the 2021 CKD-EPI equation) not receiving IHD therapy * G4: Healthy participants with normal renal function matched to participants in Groups 1 and 2 (Group 3 may be included) based on age, gender and body mass index (BMI) * G5: Participants with end stage renal disease (ESRD) receiving IHD All participants will receive a single dose of cefiderocol/xeruborbactam on Day 1.

Who Is Running the Clinical Trial?

Qpex Biopharma, Inc.

Lead Sponsor

Trials

8

Recruited

460+

Biomedical Advanced Research and Development Authority

Collaborator

Trials

108

Recruited

574,000+

Shionogi Inc.

Industry Sponsor

Trials

10

Recruited

760+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12587528/

Efficacy of cefiderocol in combination with xeruborbactam ... Preliminary results suggest that when combined with cefiderocol, xeruborbactam reduces the MIC of cefiderocol in Enterobacterales and ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT07104162

NCT07104162 | A Study to Investigate Safety and ... The aim of this study is to compare single-dose intravenous (IV) pharmacokinetics (PK) and safety of the combination of cefiderocol/xeruborbactam (S-649228) in ...

3. shionogi.com shionogi.com/us/en/news/2025/09/shionogi-to-present-new-data-from-anti-infective-portfolio-at-idweek.html

Shionogi to Present New Data from Anti-Infective Portfolio ... Poster #P-1353: Earlier Cefiderocol Use was Associated with Better Outcomes for Challenging Gram-Negative Bacterial Infections: U.S. Results ...

4. academic.oup.com academic.oup.com/jac/advance-article/doi/10.1093/jac/dkaf391/8294051?searchresult=1

Achilles' heel of the Trojan Horse? A systematic evaluation of ... Cefiderocol enters bacterial cells via passive diffusion through porins, as well as through iron-uptake mechanisms, primarily TonB-dependent ...

5. nature.com nature.com/articles/s41598-025-19084-6

Sporadic cefiderocol resistance in Escherichia coli from the ... Cefiderocol (CFDC), a novel siderophore-cephalosporin, is effective against multidrug-resistant (MDR) pathogens, but the emergence of ...

6. ctv.veeva.com ctv.veeva.com/study/a-ddi-study-to-investigate-pk-and-safety-of-cefiderocol-in-combination-with-xeruborbactam-in-healthy

A DDI Study to Investigate PK and Safety of Cefiderocol in ... A DDI Study to Investigate PK and Safety of Cefiderocol in Combination With Xeruborbactam in Healthy Adult Participants. Q. Qpex Biopharma.

7. qpexbio.com qpexbio.com/news/qpex-biopharma-announces-presentations-on-phase-1-and-nonclinical-data-on-three-clinical-stage-oral-and-iv-products-targeting-antibiotic-resistant-bacterial-infections-at-2022-id-week-meeting/

Qpex Biopharma Announces Presentations on Phase 1 ... ​In addition to clinical data, microbiological results with the beta-lactamase inhibitor xeruborbactam in combination with multiple companion beta-lactams from ...