Role of Antibiotic Therapy or Immunoglobulin On iNfections in hAematoLogy: Starting Immunoglobulin (Start Ig)

Официальное название

Role of Antibiotic Therapy or Immunoglobulin On iNfections in hAematoLogy (Start Ig)

Обзор

This study is being conducted to find out how safe and effective different strategies of infection prevention are in comparison to each other, for preventing infection in patients with blood cancers. The best way to find out this information is to directly compare the effect of different treatment strategies in patients with blood cancers. We want to know how these different treatments impact on your health and your use of healthcare services. This research project uses an Adaptive Platform Design. This design allows the researchers to compare multiple infection prevention strategies within the same trial at the same time (rather than running separate trials), to analyse results as the trial occurs and to add new research questions during the course of the trial. The treatments that you may receive as part of the study will be determined by which domain(s) of the platform you participate in. By combining data collected within each domain as part of the platform, the researchers can investigate and compare treatment strategies and infection outcomes across a broader range of participants.

Подробное описание

This is a domain within the RATIONAL Platform Trial to test the effectiveness and safety of prophylactic antibiotics as an alternative Ig replacement in patients who have not yet commenced Ig replacement therapy.

Вмешательства

• Препарат Trimethoprim / Sulfamethoxazole
  Once daily trimethoprim-sulfamethoxazole (co-trimoxazole) 160mg/800mg. NB: Doxycycline 100mg daily as an alternative for patients with hypersensitivity to co-trimoxazole.
• Биопрепарат Immune Globulin Intravenous
  IVIg every 4 weeks ± 1 week at a dose of 0.4g/kg, modified to achieve an IgG trough level of at least lower limit of age-specific serum IgG reference range; or SCIg, weekly, may be used in patients who meet local criteria for home-based self-administration in centres with established SCIg programs. Dosing is usually given at 100mg/kg/week, modified to achieve an IgG steady state level of at least the lower limit of the serum reference range. A loading IVIg dose may be given in the first month if

Первичные конечные точки

• Event-free survival (EFS). [Срок оценки: 12 months following randomisation (or, in domains with a single treatment arm, time from registration).]

Вторичные конечные точки (12)

• Occurrence of at least one Grade 3 or higher infection(s) from randomisation to 12 months. [Срок оценки: 12 months following randomisation (or, in domains with a single treatment arm, time from registration).]
• Occurrence of one or more clinically documented infections (symptoms/signs of infection requiring antimicrobial treatment) from randomisation to 12 months. [Срок оценки: 12 months following randomisation (or, in domains with a single treatment arm, time from registration).]
• Number of clinically documented infections (symptoms/signs of infection requiring antimicrobial treatment) from randomisation to 12 months. [Срок оценки: 12 months following randomisation (or, in domains with a single treatment arm, time from registration).]
• Occurrence of one or more microbiologically documented infections from randomisation to 12 months. [Срок оценки: 12 months following randomisation (or, in domains with a single treatment arm, time from registration).]
• Number of microbiologically documented infections from randomisation to 12 months. [Срок оценки: 12 months following randomisation (or, in domains with a single treatment arm, time from registration).]
• All-cause mortality at 12 months. [Срок оценки: 12 months following randomisation (or, in domains with a single treatment arm, time from registration).]
• Infection-related mortality at 12 months. [Срок оценки: 12 months following randomisation (or, in domains with a single treatment arm, time from registration).]
• Time free from hospitalisation with antimicrobial administration with therapeutic intent from randomisation to 12 months. [Срок оценки: 12 months following randomisation (or, in domains with a single treatment arm, time from registration).]
• Occurrence of one or more treatment-related adverse events. [Срок оценки: 12 months following randomisation (or, in domains with a single treatment arm, time from registration).]
• Number of treatment-related adverse events. [Срок оценки: 12 months following randomisation (or, in domains with a single treatment arm, time from registration).]
• Isolation of fluoroquinolone resistant organisms, co-trimoxazole resistant organisms, extended spectrum beta lactamases or multidrug resistant organisms from randomisation to 12 months. [Срок оценки: 12 months following randomisation (or, in domains with a single treatment arm, time from registration).]
• Number of infections with fluoroquinolone resistant organisms, co-trimoxazole resistant organisms, extended spectrum beta lactamases or multidrug resistant organisms isolated from randomisation to 12 months. [Срок оценки: 12 months following randomisation (or, in domains with a single treatment arm, time from registration).]

Критерии участия

Критерии включения

• None.

Критерии исключения

• Prior or planned allogeneic haematopoietic stem cell transplantation.
• Already receiving systemic antibiotic prophylaxis for the purpose of preventing bacterial infection (NB: patients may receive antiviral, antifungal and PJP prophylaxis).
• Received immunoglobulin replacement in the preceding three months.
• Objection to receiving immunoglobulin products.
• Known history of IgA deficiency with anti-IgA.
• History of severe allergy to immunoglobulin products.
• Current active infection requiring systemic antibiotics.
• Allergy or intolerance of all domain antibiotic options.
• Pregnant or breastfeeding.
• Severe renal impairment (estimated or measured creatinine clearance of < 30 mL/min).
• Previous splenectomy.
• Previous participation in this domain.
• Treating team deems enrolment in the domain is not in the best interest of the patient.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Австралия · 3 центра

• Royal Adelaide Hospital — Adelaide
• Austin Hospital — Melbourne
• Northern Health — Melbourne

Идентификаторы

NCT: NCT07202078 · TRU-RPT-22 Start-Ig

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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