Eravacycline Prophylaxis for Blood Cancers

Overseen By Aaron Cumpston, PharmD, BCOP

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: West Virginia University

Must not be taking: Cytochrome P450 3A4

Disqualifiers: Uncontrolled infection, Pancreatitis, Pregnancy, others

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

Prior Safety Data This treatment has passed at least one previous human trial

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

Compensation: Varies

Number of Visits: Unknown

Duration: 21 days

55 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests how well a new antibiotic, eravacycline, can prevent infections in people with blood cancers, such as acute leukemia, who face high risk due to low white blood cell counts. The focus is on preventing infections from tough-to-treat bacteria common in these patients. Suitable candidates include those undergoing chemotherapy for acute leukemia or preparing for a stem cell transplant. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group of participants.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are taking strong inhibitors or inducers of cytochrome P450 3A4. Check Appendix B for a list of these medications.

Is there any evidence suggesting that eravacycline is likely to be safe for humans?

A previous study found that eravacycline was generally well-tolerated, with most participants experiencing no serious problems. The most common side effects were mild, such as nausea or vomiting. Importantly, there were no serious issues with body temperature control. Another study involving patients with weakened immune systems, similar to those in this trial, showed that eravacycline did not cause any unexpected problems. However, like other drugs in its group, it may pose risks of teeth discoloration and temporary bone growth issues, especially in younger patients. Eravacycline is already approved for treating complicated abdominal infections, indicating its safety has been studied before. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Eravacycline is unique because it offers a new approach to infection prevention in patients with blood cancers. Unlike most current options that may have limitations in addressing drug-resistant bacteria, Eravacycline is a tetracycline antibiotic designed to be effective against a broad range of resistant pathogens. Researchers are excited about Eravacycline because it is administered intravenously, allowing for precise dosing, and it has the potential to provide more reliable prophylaxis in a population highly vulnerable to infections. This could lead to fewer complications and improve overall outcomes for patients undergoing treatment for blood cancers.

What evidence suggests that eravacycline might be an effective treatment for blood cancers?

Research has shown that eravacycline, the investigational treatment in this trial, effectively combats many drug-resistant bacteria. These bacteria often cause infections in individuals with weakened immune systems, such as those undergoing blood cancer treatments. Studies have demonstrated that eravacycline works well against MRSA, VRE, and Clostridioides difficile, common infections in this group. It also targets most gut-related bacteria and penetrates tissues effectively, addressing previous issues with similar drugs. Evidence indicates it is effective against coagulase-negative staphylococcus, a common cause of catheter-related infections in these patients. These findings suggest eravacycline could be a strong option for preventing infections in patients with prolonged low white blood cell counts. ^{4 6 7 8 9}

Who Is on the Research Team?

Aaron Cumpston, PharmD, BCOP

Principal Investigator

West Virginia University

Are You a Good Fit for This Trial?

This trial is for patients with blood cancers undergoing acute leukemia therapy or stem cell transplant, expected to have very low white blood cells for over a week. They must understand the study and agree to participate, have certain liver function test levels within set limits, and not be pregnant or breastfeeding.

Inclusion Criteria

Patient must provide informed consent

Bilirubin ≤ 3 x the ULN and AST/ALT ≤ 5 x ULN

I am undergoing chemotherapy for acute leukemia or preparing for a stem cell transplant.

Exclusion Criteria

I am currently being treated for a urinary tract infection.

I am not taking any strong medication that affects liver enzymes.

Pregnant or lactating women

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Eravacycline prophylaxis for hematologic malignancy patients with prolonged neutropenia

21 days

Daily visits for IV infusion

Follow-up

Participants are monitored for safety and effectiveness after treatment

30 days

Long-term follow-up

Participants are monitored for long-term outcomes such as infection-related mortality and acute GVHD

100 days

What Are the Treatments Tested in This Trial?

Interventions

• Eravacycline

Trial Overview The trial tests Xerava™ (eravacycline) as a preventive antibiotic in patients at high risk of infection due to prolonged neutropenia from leukemia treatment or stem cell transplant. The goal is to see if it can prevent infections better than current treatments.

How Is the Trial Designed?

Group I: Eravacycline Experimental Treatment 1 Intervention

Eravacycline- 1 mg/kg actual body weight IV Infusion over 60 minutes every 12 hours. Alternative dosing strategy 1.5mg/kg every 12 hourse.

Eravacycline is already approved in United States for the following indications:

Approved in United States as Xerava for:

• Complicated intra-abdominal infections

Who Is Running the Clinical Trial?

West Virginia University

Lead Sponsor

Trials

192

Recruited

64,700+

Published Research Related to This Trial

In a study of 197 cancer patients, 13.4% developed bloodstream infections from vancomycin-resistant Enterococcus faecium (VRE), highlighting the serious risk of VRE infections in this population.

Key risk factors for developing VRE bloodstream infections included the use of vancomycin, diabetes, gastrointestinal procedures, and acute renal failure, suggesting that limiting vancomycin use and gastrointestinal interventions could help prevent these infections.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Risk factors for development of vancomycin-resistant enterococcal bloodstream infection in patients with cancer who are colonized with vancomycin-resistant enterococci. Zaas, AK., Song, X., Tucker, P., et al.[2007]

In a study of 434 allogeneic hematopoietic stem cell transplantation (allo-HSCT) recipients, empiric therapy for vancomycin-resistant Enterococcus (VRE) bacteremia did not show a significant benefit compared to directed therapy, with similar clinical outcomes such as duration of bacteremia and mortality rates.

The findings suggest that empiric use of VRE-active agents in febrile, neutropenic patients who are VRE-colonized is not recommended, as it did not improve survival or reduce complications compared to targeted treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of Empiric Treatment for Vancomycin-Resistant Enterococcus in Colonized Patients Early after Allogeneic Hematopoietic Stem Cell Transplantation. Kamboj, M., Cohen, N., Huang, YT., et al.[2020]

In a study of 56 neutropenic cancer patients colonized with vancomycin-resistant enterococci (VRE), those with acute leukemia were significantly more likely to develop VRE bacteremia, with 100% of affected patients having acute leukemia compared to 56% of those without bacteremia.

C. difficile infection was identified as a major risk factor for developing VRE bacteremia, with a risk ratio of 8.2, highlighting the importance of monitoring for C. difficile in VRE-colonized patients, especially those with acute leukemia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clostridium difficile infection is a risk factor for bacteremia due to vancomycin-resistant enterococci (VRE) in VRE-colonized patients with acute leukemia. Roghmann, MC., McCarter, RJ., Brewrink, J., et al.[2020]

In a study of allogeneic hematopoietic cell transplantation patients, VRE bacteremia (VREB) was found to be infrequent, indicating a low incidence of this infection in the cohort.

Colonized patients were more likely to receive VRE-directed therapy compared to noncolonized patients, suggesting that screening for VRE may influence treatment decisions even in the absence of active infection.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Unintended Consequences of Pretransplant Vancomycin-Resistant Enterococcus Screening on Antimicrobial Stewardship Among Allogeneic Hematopoietic Cell Transplant Recipients. Stohs, EJ., MacAllister, T., Pergam, SA., et al.[2019]

In a study involving 56 oncology patients with vancomycin-resistant enterococci (VRE) infections, the combination of quinopristin-dalfopristin and minocycline showed a response rate of 68%, indicating its effectiveness against these infections.

The treatment was associated with a notable side effect, with 36% of patients experiencing arthralgia or myalgia, highlighting the need to consider potential adverse effects when using this therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of vancomycin-resistant enterococcal infections in the immunocompromised host: quinupristin-dalfopristin in combination with minocycline. Raad, I., Hachem, R., Hanna, H., et al.[2018]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12502764/

Eravacycline use in immunocompromised patients Infections from multidrug-resistant (MDR) bacteria lead to worse outcomes in immunocompromised patients. Eravacycline (ERV) is effective ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9981869/

In vitro activity of eravacycline and comparator agents ... We evaluated the in vitro activity of eravacycline and comparator agents commonly used in patients with cancer against 255 GPB and 310 GNB ...

3. link.springer.com link.springer.com/article/10.1007/s40121-025-01206-2

Effective Management of Carbapenem-Resistant ... This report describes three patients with hematological malignancies complicated by long-term severe neutropenia who were successfully treated ...

4. newmicrobiologica.org newmicrobiologica.org/wp-content/uploads/2025/07/MICRO_2_2025_1.2_FULL_496N542_Martini-137-146-1.pdf

Eravacycline: Data Based on Real Evidence Death occurred in one patient with cancer who was treated success- fully for blood stream infection due to B. fragilis but died due to ...

5. journals.asm.org journals.asm.org/doi/abs/10.1128/spectrum.00565-25

Eravacycline use in immunocompromised patients Kaplan-Meier analysis showed a higher cumulative proportion of clinical treatment failure in the late ERV group (57%) compared to the timely ERV ...

6. xerava.com xerava.com/efficacy-and-safety

Efficacy & Safety | XERAVA® (eravacycline) Learn about trial design, clinical response, and safety data for XERAVA® (eravacycline). See Safety Information and Full Prescribing Information.

7. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2025/211109s014lbl.pdf

XERAVA® (eravacycline) for injection, for intravenous use Risk Summary. XERAVA, like other tetracycline-class antibacterial drugs, may cause discoloration of deciduous teeth and reversible inhibition of bone growth ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT06794541

NCT06794541 | A Study to Evaluate the Safety and ... A Phase 2 trial to assess safety, tolerability, and pharmacokinetics of eravacycline in pediatric patients aged 8 to <18 years with cIAI. Official Title.

9. ema.europa.eu ema.europa.eu/en/documents/assessment-report/xerava-epar-public-assessment-report_en.pdf

xerava-epar-public-assessment-report_en.pdf - EMA However, in the clinical safety data base there are no indications on thermoregulatory effects of eravacycline at clinically relevant doses.