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

Официальное название

Prospective Evaluation of Xerava™ (Eravacycline) Prophylaxis in Hematological Malignancy Patients With Prolonged Neutropenia

Обзор

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.

Подробное описание

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) is a synthetic halogenated tetracycline class antibiotic, with 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. Adverse effects with this agent are minimal including infusion site reactions and gastrointestinal disorders. 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.

Вмешательства

• Препарат Eravacycline
  Eravacycline 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)

Первичные конечные точки

• Incidence of Documented Breakthrough Infections [Срок оценки: Up to 21 days]

Вторичные конечные точки (6)

• Adverse Events [Срок оценки: Daily during Eravacycline]
• Infection-related mortality [Срок оценки: Up to 30 days]
• All-cause mortality [Срок оценки: Up to 30 days]
• Acute GVHD [Срок оценки: Up to 100 days]
• Neutropenic fever [Срок оценки: Up to 21 days]
• Time to neutropenic fever [Срок оценки: Up to 21 days]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Aaron Cumpston — Morgantown

Идентификаторы

NCT: NCT05537896 · 2206591296

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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