Burden of Cytomegalovirus Reactivation in Pediatric Patients After Allogeneic Hematopoietic Stem Cell Transplantation
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
- Кому может быть актуально
- Состояния в реестре: Cytomegalovirus Infection, Hematopoietic Stem Cells Transplantation. Базовые параметры: 0 лет — 18 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Италия
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
CMV PED Study - A Retrospective Observational Study To Understand The Clinical And Economic Burden Associated With Cytomegalovirus Reactivation and Related Health Outcomes In Pediatric Patients Receiving Allogeneic Hematopoietic Stem Cell Transplantation In Italy
Обзор
This observational retrospective analysis will provide useful information for clinicians and payers, and local guidelines committee members, to improve the understanding of Cytomegalovirus clinical and economic burden and clinical management of pediatric patients undergoing allogeneic Hematopoietic Stem Cells Transplantation in Italy.
Подробное описание
This is an observational retrospective analysis from the main pediatric centers in Italy (approximately 5 sites). The selected sites will be the most representative of Italy because they perform about 2/3 of all allogeneic HSCT per year.
Index date: date of allogeneic HSCT; retrospective data will be captured in consecutive patients undergoing allogeneic HSCT from January 2018 to June 2020 with maximum 12 months of follow-up for each patient. The data of the patients undergoing allogeneic HSCT after June 2020 will not be captured in order to avoid any possible bias due to off-label access to letermovir.
Medical Records (MR) will be used to describe the risk factors, patient characteristics, treatment patterns, and healthcare resource utilization of subjects who had a CMV infection.
Electronic or paper hospital charts (inpatient), clinical charts (inpatient and outpatient), and outpatient records will all be considered as MR for study purposes.
This is a secondary data collection study from electronic or paper medical chart review, no data from registry will be collected.
Patients (or their legally acceptable representatives) must have signed and dated the Informed Consent \& Privacy Form (ICF), if applicable.
Первичные конечные точки
- Summary of demographic and baseline characteristics [Срок оценки: at baseline (day of transplant)]
- CMV Seroprevalence in the under 18 population undergoing allogeneic HSCT [Срок оценки: at baseline (day of transplant)]
- CMV serostatus [Срок оценки: at baseline (day of transplant)]
- Donor type [Срок оценки: at baseline (day of transplant)]
- Stem cell source [Срок оценки: at baseline (day of transplant)]
- Conditioning intensity [Срок оценки: at baseline (day of transplant)]
- Underlying condition [Срок оценки: at baseline (day of transplant)]
- Usage of immunosuppression [Срок оценки: at baseline (day of transplant)]
- Current standard of care in CMV management in terms of PET approach [Срок оценки: during the first-year post-transplant]
- Current standard of care in CMV management in terms of GCV prophylaxis [Срок оценки: during the first-year post-transplant]
Вторичные конечные точки (11)
- Rate of clinically significant CMV infection [Срок оценки: at day +100, day +200 and during the first year post allogeneic HCT]
- Median time to first CS-CMVi [Срок оценки: during the first year after transplantation]
- Rate of viral infections other than CMV [Срок оценки: at day +100, day +200 and during the first year post allogeneic HCT]
- Rate of bacterial infections [Срок оценки: at day +100, day +200 and during the first year post allogeneic HCT]
- Rate of fungal infections [Срок оценки: at day +100, day +200 and during the first year post allogeneic HCT]
- Allogeneic HSCT risk factors [Срок оценки: at baseline (day of transplant)]
- CMV-related complications [Срок оценки: during the first-year post-transplant]
- CMV-related complications [Срок оценки: at day +100, day +200 and during the first year post allogeneic HCT]
- CMV-related complications [Срок оценки: during the first-year post-transplant]
- Number of hospitalizations and length of stay (LOS) after allogeneic HSCT [Срок оценки: at day +100, day +200 and during the first year post allogeneic HCT]
- All-cause mortality rate [Срок оценки: at day +100, day +200 and during the first year post allogeneic HCT]
Критерии участия
Критерии включения
- Patients from birth to less than 18 years of age (at the moment of the allogeneic HSCT);
- Patients who received allogeneic HSCT between January 2018 and June 2020;
- Patients (or their legally acceptable representatives) must have signed and dated the Informed Consent \& Privacy Form (ICF), if applicable.
Критерии исключения
- Letermovir use at any time
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
Италия · 5 центров
- IRCCS Istituto Giannina Gaslini, Trapianto di Cellule Staminali Emopoietiche, Dipartimento — Genova
- Ospedale San Gerardo, Clinica Pediatrica — Monza
- Azienda Ospedale-Università di Padova, Clinica di Oncoematologia Pediatrica — Padova
- IRCCS Ospedale Pediatrico Bambino Gesù, Dipartimento di Pediatria Ematologia e Oncologia — Roma
- Ospedale Infantile Regina Margherita, Dipartimento Patologia e Cura del Bambino — Torino
Идентификаторы
NCT: NCT06916195 · NIS103043