CTIS2024-515925-27-00进行中（未招募）1 期
Effectiveness of a preventive strategy for cytomegalovirus infection guided differently from a universal prophylactic strategy in kidney transplant patients - CYTOPREV - 2020/0422/HP
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 144
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 65+（—）
- 性别
- All
入选标准
- •18 years = Age = 75 years, Renal transplant patient for 1 to 12 days, CMV seropositivity on the day of transplantation: IgG threshold =6 AU/mL CMIA CMV IgG, Architect i4000 (Abbott)) (Serology performed on D0, before the transplant), Non-depleting inducing immunosuppressive treatment (Basiliximab) (implementation before the transplant), Affiliation to a social security scheme, Patient having read and understood the information letter and signed, For women: - Woman of childbearing potential using effective contraception (Cf. CTFG) (estrogen-progestin or intrauterine device or tubal ligation) for at least 1 month and a negative ß-HCG blood pregnancy test at inclusion, throughout the duration of study treatment and for at least 30 days after stopping study treatment. - Postmenopausal woman: confirmatory diagnosis (non-medically induced amenorrhea for at least 12 months before the inclusion visit) - Surgically sterile woman (absence of ovary and/or uterus), Pour les hommes : - Stérilité chirurgicale, ou - Contraception mécanique (préservatif) pendant toute la durée du traitement à l’étude et pendant au moins 90 jours après la fin du traitement à l’étude, ou - Avec une partenaire en âge de procréer prenant une contraception efficace (Cf. CTFG) (oestro-progestatifs ou dispositif intra-utérin ou ligature de trompes) depuis au moins 1 mois à l’inclusion, pendant toute la durée du traitement à l’étude et pendant au moins 90 jours après l’arrêt du traitement, ou - Avec une partenaire ménopausée : diagnostic de confirmation (aménorrhée non médicalement induite depuis au moins 12 mois avant la visite d’inclusion), ou - Avec une partenaire chirurgicalement stérile (absence d’ovaire et/ou d’utérus).
排除标准
- •Age < 18 or > 75, Active CMV infection (detectable CMV DNAemia - peripheral CMV DNAemia = 305 IU/mL), Patient with hypersensitivity to valganciclovir, ganciclovir, aciclovir or valaciclovir or to any of the excipients, Lympho-depleting inducing immunosuppressive treatment (antithymoglobulins), Neutropenia (neutrophils < 500/mm3) or thrombocytopenia (platelets < 25,000/mm3) or anemia (hemoglobin < 8g/dl) identified on routine care samples taken on the day of inclusion, Pregnant or parturient or breast-feeding woman or absence of proven contraception, Person deprived of liberty by an administrative or judicial decision or person placed under legal safeguard / sub-tutorship or curatorship, History of illness or psychological or sensory abnormality likely to prevent the subject from fully understanding the conditions required for their participation in the protocol or preventing them from giving their informed consent, Person participating in another interventional trial (Medicinal product)
研究者
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