Prospective Evaluation of Xerava Prophylaxis in Hematological Malignancy Patients With Prolonged Neutropenia
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorWest Virginia University
About this trial
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 breakthrough infections during eravacycline prophylaxis for hematologic malignancy patients with prolonged neutropenia.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Eravacycline
DrugEravacycline will be continued until one of the following criteria is met: * neutrophil recovery (ANC \>500, post-nadir) * febrile neutropenia * breakthrough infection * any grade 3-4 toxicity related to eravacycline use * 21 days of therapy (maximum duration allowed per study protocol)
Treatment groups
55 Participants
are divided into 1 treatment groupGroup A: EravacyclineExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Incidence of Documented Breakthrough Infections
Number of Incidences documented that subjects had a confirmed breakthrough infection.
Time frame
Up to 21 daysSecondary outcomes
1
Adverse Events
Incidence of Adverse Events: CTCAE criteria. CTCAE stands for Common Terminology Criteria for Adverse Events; these criteria are also called "common toxicity criteria." In CTCAE, an adverse event (AE) is defined as any abnormal clinical finding temporally associated with the use of a therapy for cancer; causality is not required. These criteria are used for the management of chemotherapy administration and dosing, and in clinical trials to provide standardization and consistency in the definition of treatment-related toxicity.
Time frame
Daily during Eravacycline2
Infection-related mortality
Incidence of Infection-related mortality. Infection-related mortality is defined as any death that occurred in the presence of clinical or microbiological documented infection
Time frame
Up to 30 days3
All-cause mortality
Incidence of All-cause mortality defined as any death occurring during the clinical trial period.
Time frame
Up to 30 days4
Acute GVHD
Incidence of Acute Graft vs Host Disease (GVHD). GVHD is a complication of a bone marrow or stem cell transplant in which cells from a donor attack the tissues of the recipient.
Time frame
Up to 100 daysSponsors and contacts
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Source ClinicalTrials.gov