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New treatment option for Hematological Malignancy
Official title Prospective Evaluation of Xerava Prophylaxis in Hematological Malignancy Patients With Prolonged Neutropenia
ClinicalTrials.gov ID: NCT05537896
What this study is testing
What is Eravacycline?
Eravacycline is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for hematological malignancy.
Also referred to as Xerava.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- All patients receiving induction chemotherapy for treatment of acute leukemia or receiving preparative regimen for HSCT
- Patient must provide informed consent.
- Bilirubin ≤ 3 x the ULN and AST/ALT ≤ 5 x ULN
You likely can't join if
- Uncontrolled bacterial, viral or fungal infection at the time of study enrollment.
- Urinary tract infection receiving active treatment
- Acute pancreatitis (not necessary to work-up unless symptomatic)
- History of known hypersensitivity to eravacycline, tetracycline, doxycycline, minocycline, tigecycline, sarecycline, oxytetracycline, or omadacycline
- Pseudomonas infection within 30 days prior to study enrollment
- Receiving strong inhibitors or inducers of cytochrome P450 3A4 will be excluded from the study (see Appendix B for complete list of medications)
See the full eligibility criteria
- All patients receiving induction chemotherapy for treatment of acute leukemia or receiving preparative regimen for HSCT
- Patient must provide informed consent.
- Bilirubin ≤ 3 x the ULN and AST/ALT ≤ 5 x ULN
- Uncontrolled bacterial, viral or fungal infection at the time of study enrollment.
- Urinary tract infection receiving active treatment
- Acute pancreatitis (not necessary to work-up unless symptomatic)
- History of known hypersensitivity to eravacycline, tetracycline, doxycycline, minocycline, tigecycline, sarecycline, oxytetracycline, or omadacycline
- Pseudomonas infection within 30 days prior to study enrollment
- Receiving strong inhibitors or inducers of cytochrome P450 3A4 will be excluded from the study (see Appendix B for complete list of medications)
- Pregnant or lactating women
The study team makes the final eligibility decision.
Where it's taking place
- Morgantown, West Virginia, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Morgantown, West Virginia, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.