Xeruborbactam + Cefiderocol for Bacterial Infections

No longer recruiting at 1 trial location

Overseen By Jeff Loutit, MBChB

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Qpex Biopharma, Inc.

Must not be taking: Beta-lactams

Disqualifiers: Cardiovascular, Pulmonary, Renal, others

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how the drugs xeruborbactam and cefiderocol work together to treat bacterial infections. Researchers aim to assess the safety of the combination and its movement through the body. Participants will receive either a single or multiple doses of these drugs, or a placebo (a harmless substance that resembles the drug but has no effect). This trial targets healthy adults willing to participate who do not have significant health issues, such as heart or liver problems. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new combination therapy.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Previous studies have generally shown that cefiderocol is well tolerated by patients, even those with serious infections. It is already used in real-world settings for hard-to-treat bacterial infections and has demonstrated good safety results. However, some studies have reported higher rates of certain side effects, which should be considered.

Research on xeruborbactam has shown it to be safe and well tolerated at doses of 1,000 mg per day or less. In earlier tests, most participants did not experience severe side effects.

The combination of xeruborbactam and cefiderocol remains under study. Initial findings from similar trials suggest that the combination is safe. However, it is important to note that this is a phase 1 study, focusing on assessing safety and determining the right dose. Safety data is still being collected. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about Xeruborbactam and Cefiderocol because they offer a novel approach to tackling bacterial infections that are becoming increasingly resistant to standard antibiotics. Unlike traditional antibiotics, Cefiderocol has a unique mechanism of action; it acts as a trojan horse, using the bacteria's own iron transport system to infiltrate and kill the bacteria from within. Xeruborbactam enhances the effectiveness of Cefiderocol by inhibiting beta-lactamase enzymes that some bacteria produce to resist antibiotics. This combination could be a game-changer, especially for hard-to-treat infections where current treatments may fail.

What evidence suggests that this trial's treatments could be effective for bacterial infections?

Studies have shown that cefiderocol effectively combats tough, resistant bacteria, with about 64% of patients achieving a clinical cure in various infections. It has successfully treated complicated urinary tract infections, with many patients responding well. Xeruborbactam, on its own, can fight bacteria and enhances antibiotics by blocking enzymes that cause resistance. While xeruborbactam alone might not have a significant impact, it is believed to boost cefiderocol's effectiveness. In this trial, participants will receive cefiderocol, xeruborbactam, or a combination of both. Research suggests that combining cefiderocol with xeruborbactam could overcome resistance in bacteria that cefiderocol alone struggles to treat. This combination is under study for its potential to more effectively fight infections caused by superbugs. ^{3 4 6 7 8}

Are You a Good Fit for This Trial?

This trial is for healthy adults who can participate in a study to understand how two drugs interact with each other. Specific eligibility details are not provided, but typically participants should have no significant health issues.

Inclusion Criteria

Body mass index (BMI) ≥ 18.5 and ≤ 32 (kg/m2) and weight between 55.0 and 100.0 kg

Voluntary consent to participate in the study

I am in good health as confirmed by recent medical exams.

Exclusion Criteria

Documented hypersensitivity reaction or anaphylaxis to any medication

I am allergic to certain antibiotics like penicillins or cephalosporins.

Active drug or alcohol abuse within 2 years prior to the initial study drug administration

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive a single fixed dose of Xeruborbactam, Cefiderocol, or a combination of both, or placebo

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and pharmacokinetic parameters after dosing

17 days

Multiple visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Xeruborbactam/Cefiderocol

Trial Overview The study tests the interaction between Xeruborbactam and Cefiderocol, both antibiotics, in healthy adults. It's randomized and placebo-controlled, meaning some people get the real drugs while others get an inactive substance without knowing which one they received.

How Is the Trial Designed?

Group I: Single Dose Cohorts Experimental Treatment 3 Interventions

Administered single fixed dose of Xeruborbactam Administered single fixed dose of Cefiderocol Administered single fixed dose of a combination of Xeruborbactam and Cefiderocol.

Group II: Multiple Dose Cohort Xeruborbactam Experimental Treatment 1 Intervention

Administered multiple fixed doses of Xeruborbactam

Group III: Multiple Dose Cohort Cefiderocol and Xeruborbactam Experimental Treatment 1 Intervention

Administered multiple fixed doses of a combination of Cefiderocol and Xeruborbactam.

Group IV: Multiple Dose Cohort Cefiderocol Experimental Treatment 1 Intervention

Administered multiple fixed doses of Cefiderocol

Group V: Multiple Dose Cohort Placebo Placebo Group 1 Intervention

Administered multiple fixed volumes of a placebo comparator

Group VI: Single Dose Cohorts Placebo Placebo Group 1 Intervention

Administered single fixed volume of a placebo comparator

Xeruborbactam/Cefiderocol is already approved in United States for the following indications:

Approved in United States as Fetroja (cefiderocol) for:

• Complicated urinary tract infections including pyelonephritis
• Hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia

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+

Published Research Related to This Trial

Cefiderocol is the first siderophore cephalosporin approved for treating serious Gram-negative bacterial infections, showing strong effectiveness against multidrug-resistant strains and stability against various β-lactamases.

In clinical trials, cefiderocol was found to be noninferior to standard treatments for complicated urinary tract infections and nosocomial pneumonia, although it had a higher all-cause mortality rate in patients with carbapenem-resistant infections, indicating the need for careful patient selection.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cefiderocol: A Review in Serious Gram-Negative Bacterial Infections. Syed, YY.[2023]

Cefiderocol is a new antibiotic that effectively targets Gram-negative bacteria by utilizing their iron transport systems, making it a promising option for treating complicated urinary tract infections and certain types of pneumonia in adults with limited treatment options.

However, the CREDIBLE-CR trial indicated a higher all-cause mortality in patients treated with cefiderocol, particularly those with severe infections from Acinetobacter spp., highlighting the need for further phase III studies to assess its safety and efficacy in serious infections.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cefiderocol, a new antibiotic against multidrug-resistant Gram-negative bacteria. Silva, JT., López-Medrano, F.[2023]

Cefiderocol is effective against complicated urinary tract infections (cUTIs) caused by Gram-negative bacteria, showing a higher clinical and microbiological eradication rate compared to imipenem-cilastatin (73% vs. 55%).

Despite its efficacy, cefiderocol is associated with higher all-cause mortality in certain patients, and its use should be restricted to cases where alternative treatments are limited, particularly in patients with renal impairment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cefiderocol, a New Siderophore Cephalosporin for the Treatment of Complicated Urinary Tract Infections Caused by Multidrug-Resistant Pathogens: Preclinical and Clinical Pharmacokinetics, Pharmacodynamics, Efficacy and Safety. Lee, YR., Yeo, S.[2023]

Cefiderocol is a new antibiotic effective against difficult-to-treat gram-negative bacteria, including those resistant to carbapenems, as shown in clinical trials for hospital-acquired pneumonia.

Despite its efficacy, a clinical trial indicated an increase in mortality in patients treated with cefiderocol, highlighting the need for further evaluation of its safety and effectiveness in real-world settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cefiderocol. Soriano, MC., Montufar, J., Blandino-Ortiz, A.[2023]

Cefiderocol is a novel antibiotic that effectively targets multi-drug resistant (MDR) Gram-negative bacteria by utilizing a unique mechanism that allows it to transport iron across bacterial membranes, leading to cell wall synthesis inhibition.

While cefiderocol showed non-inferiority to other antibiotics like imipenem and meropenem in treating complicated urinary tract infections and hospital-acquired pneumonia, it was associated with higher all-cause mortality in patients with severe infections from Acinetobacter spp., highlighting the need for careful patient selection.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cefiderocol: a novel siderophore cephalosporin for multidrug-resistant Gram-negative bacterial infections. Parsels, KA., Mastro, KA., Steele, JM., et al.[2023]

Cefiderocol is a newly approved antibiotic that shows effectiveness against multidrug-resistant (MDR) bacteria, including common pathogens in cystic fibrosis patients, such as Pseudomonas aeruginosa and Stenotrophomonas maltophilia.

While cefiderocol has demonstrated potential with minimum inhibitory concentrations (MICs) of ≤4 mg/L, there is currently no in vivo evidence specifically in cystic fibrosis patients, suggesting it should be considered when other treatment options are limited.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does Cefiderocol Have a Potential Role in Cystic Fibrosis Pulmonary Exacerbation Management? Gavioli, EM., Guardado, N., Haniff, F., et al.[2023]

Citations

1. shionogi.com shionogi.com/global/en/news/2025/10/20251021.html

IDWeek 2025: Shionogi Presents Real-World and ... Additional real-world data from PROVE showed that cefiderocol is effective against bacteria that are both susceptible (clinical cure rate: 70.5 ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11490232/

Effectiveness and Safety of Cefiderocol in Clinical Practice ... Clinical cure was reported for 64.8% (158/244) of patients, clinical response for 74.2% (181/244), and 9.4% (23/244) had relapse/reinfection; 30 ...

3. fetroja.com fetroja.com/real-world-evidence

Fetroja® (cefiderocol) | Real-World Evidence | PROVE Outcomes in patients with urinary tract infections: 93.3% (14/15) overall clinical response at EOT and 6.7% (1/15) overall 30-day ACM.

4. academic.oup.com academic.oup.com/ofid/article/12/Supplement_1/ofae631.1645/7987550

P-1475. Real-World Effectiveness and Safety of Cefiderocol in ... In monomicrobial and polymicrobial infections, clinical cure rates were 63.6% and 65.0%, while ACM rates were 25.6% and 20.0% at day 30, ...

5. contagionlive.com contagionlive.com/view/cefiderocol-demonstrates-better-outcomes-as-empiric-or-documented-therapy-as-compared-to-salvage-therapy

Cefiderocol Demonstrates Better Outcomes as Empiric or ... In previous data reported at last year's IDWeek, cefiderocol demonstrated a clinical cure rate of 64% and a response rate of 71.6% by the end of ...

6. shionogi.com shionogi.com/us/en/news/2025/10/idweek-2025-shionogi-presents-real-world-and-surveillance-data-reinforcing-role-of-cefiderocol-across-range-of-patient-populations-and-difficult-to-treat-infections.html

IDWeek 2025: Shionogi Presents Real-World and ... “These results demonstrate that cefiderocol effectively treated seriously ill patients with a range of GN pathogens across multiple infection ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39431212/

Effectiveness and Safety of Cefiderocol in Clinical Practice ... Cefiderocol was well tolerated in real-world settings in critically ill US patients with problematic Gram-negative pathogens. Keywords: ...

8. link.springer.com link.springer.com/article/10.1007/s10096-025-05108-6

Effectiveness and safety of cefiderocol treatment in patients ... Cefiderocol was well tolerated in this critically ill population. The data corroborate the value of cefiderocol as an appropriate antibiotic ...