Xerava for Neutropenia

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Aaron Cumpston, Morgantown, WV
Neutropenia+3 More
Eravacycline - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

Antibacterial prophylaxis is recommended in patients at high risk of infection, specifically patients undergoing acute leukemia induction therapy or hematopoietic stem cell transplant (HSCT) who are expected to have profound neutropenia (ANC<100 neutrophils/milliliter) for more than seven days. Xerava™ (eravacycline) has a broad spectrum of activity including many multi-drug resistant strains of bacteria. It is not an agent used for treatment of febrile neutropenia, making eravacycline a very attractive alternative to consider in this prophylactic setting. Eravacycline has activity against MRSA, VRE, and Clostridioides difficile, all of which are common problems in this patient population. It also covers the majority of enteric gram-negative pathogens while also producing satisfactory tissue penetration and adequate plasma concentrations, which has classically been a concern with prior agents. Eravacycline has activity against coagulase-negative staphylococcus, which is a common catheter-related infection in leukemia and HSCT patients. The primary objective will be report the incidence of antibiotic prophylaxis failure with eravacycline prophylaxis for hematologic malignancy patients with prolonged neutropenia.

Eligible Conditions

  • Neutropenia
  • Haematological Malignancies

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Neutropenia

Study Objectives

2 Primary · 4 Secondary · Reporting Duration: Daily during Eravacycline

Daily during Eravacycline
Adverse Events
Up to 114 days
Acute GVHD
All-cause mortality
Antibiotic Prophylaxis Failure- Time
Antibiotic Prophylaxis Failure-Incidence
Infection-related mortality

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Other trials for Neutropenia

Side Effects for

Eravacycline, 1.0 mg/kg q12h
8%Nausea
4%Vomiting
3%Anaemia
3%Phlebitis
2%Pyrexia
1%Wound dehiscence
1%Pneumonia
0%Pulmonary artery thrombosis
0%Multi-organ failure
0%Biliary drainage
0%Abdominal abscess
0%Cardiopulmonary failure
0%Atrial fibrillation
0%Abdominal wound dehiscence
0%Wound evisceration
0%Respiratory disorder
0%Pancreatitis necrotising
0%Duodenal ulcer haemorrhage
0%Abdominal compartment syndrome
0%Sepsis
0%Pulmonary embolism
0%Haematoma infection
0%Empyema
0%Acute respiratory failure
0%Gastrointestinal stoma complication
0%Pulseless electrical activity
0%Supraventricular tachycardia
0%Diverticular perforation
0%Ileus
0%Oesophageal fistula
0%Splenic rupture
0%Acute respiratory distress syndrome
0%Liver abscess
0%Cerebrovascular accident
0%Septic shock
0%Deep vein thrombosis
0%Peritonitis
0%Colonic fistula
0%Respiratory failure
0%Pleural effusion
0%Intestinal fistula
0%Peritoneal abscess
This histogram enumerates side effects from a completed 2014 Phase 3 trial (NCT01844856) in the Eravacycline, 1.0 mg/kg q12h ARM group. Side effects include: Nausea with 8%, Vomiting with 4%, Anaemia with 3%, Phlebitis with 3%, Pyrexia with 2%.

Trial Design

1 Treatment Group

Xerava
1 of 1
Experimental Treatment

55 Total Participants · 1 Treatment Group

Primary Treatment: Xerava · No Placebo Group · Phase 2

Xerava
Drug
Experimental Group · 1 Intervention: Eravacycline · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Eravacycline
2014
Completed Phase 3
~3160

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: daily during eravacycline

Trial Background

Aaron Cumpston PharmD, BCOP, Pharmacy Clinical Specialist
Principal Investigator
West Virginia University
Closest Location: Aaron Cumpston · Morgantown, WV
N/AFirst Recorded Clinical Trial
1 TrialsResearching Neutropenia
0 CompletedClinical Trials

Eligibility Criteria

Age 18+ · All Participants · 3 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have provided informed consent.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.