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Tetracycline Antibiotic

Eravacycline Prophylaxis for Blood Cancers

Phase 2

Recruiting

Led By Aaron Cumpston, PharmD, BCOP

Research Sponsored by West Virginia University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 100 days

Awards & highlights

Study Summary

This trial will evaluate the use of the drug eravacycline as a prophylactic measure against infection in high-risk leukemia and stem cell transplant patients.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Eravacycline may cause allergic reactions in those sensitive to tetracyclines. It could also interact with other drugs affecting the liver enzyme cytochrome P450 3A4, leading to potential side effects that are not yet fully known.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ daily during eravacycline

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~daily during eravacycline

This trial's timeline: 3 weeks for screening, Varies for treatment, and daily during eravacycline for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Incidence of Documented Breakthrough Infections

Secondary outcome measures

Acute GVHD

Adverse Events

All-cause mortality

+3 more

Side effects data

From 2014 Phase 3 trial • 541 Patients • NCT01844856

Nausea

Vomiting

Anaemia

Phlebitis

Pyrexia

Pneumonia

Wound dehiscence

100%

80%

60%

40%

20%

Study treatment Arm

Eravacycline, 1.0 mg/kg q12h

Ertapenem, 1.0 g q24h

Trial Design

1Treatment groups

Experimental Treatment

Group I: EravacyclineExperimental Treatment1 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Eravacycline

2014

Completed Phase 3

~3160

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

West Virginia UniversityLead Sponsor

176 Previous Clinical Trials

60,159 Total Patients Enrolled

Aaron Cumpston, PharmD, BCOPPrincipal InvestigatorWest Virginia University

2 Previous Clinical Trials

50 Total Patients Enrolled

1 Trials studying Neutropenia

30 Patients Enrolled for Neutropenia

Media Library

Eravacycline (Tetracycline Antibiotic) Clinical Trial Eligibility Overview. Trial Name: NCT05537896 — Phase 2

Neutropenia Research Study Groups: Eravacycline

Neutropenia Clinical Trial 2023: Eravacycline Highlights & Side Effects. Trial Name: NCT05537896 — Phase 2

Eravacycline (Tetracycline Antibiotic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05537896 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is Eravacycline a viable option for patients in terms of safety?

"Our Power team has rated the security of Eravacycline at 2 due to its Phase 2 status; there is some evidence indicating safety but no information on efficacy."

Answered by AI

What is the purpose of this research endeavor?

"This medical experiment's primary outcome, measured over 114 days, is the rate of Antibiotic Prophylaxis Failure-Time. Secondary goals include determining Infection-related mortality (deaths due to documented infection), gauging Acute GVHD incidences (a complication following bone marrow or stem cell transplantation where donor cells attack recipient tissues), and calculating Adverse Events via CTCAE criteria (Common Terminology Criteria for Adverse Events)."

Answered by AI

Are there any unfilled vacancies for enrolment in this clinical trial?

"Data available on clinicaltrials.gov indicates that this investigation is no longer looking for participants, with the original posting date being October 1st 2022 and the last update occurring in September 12th 2022. Despite this trial's closure, there are still 2568 other investigations actively recruiting patients."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Prospective Evaluation of Xerava Prophylaxis in Hematological Malignancy Patients With Prolonged Neutropenia

Aaron Cumpston, PharmD, BCOP 2024. "Prospective Evaluation of Xerava Prophylaxis in Hematological Malignancy Patients With Prolonged Neutropenia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05537896.