Teicoplanin as Infection Prophylaxis in Pediatric Acute Myeloid Leukemia (Pro-Teico study)An open-label, randomized clinical trial on teicoplanin infection prophylaxis in pediatric patients with acute myeloid leukemia - SP_MH19PRO

Prinses Maxima Centrum voor Kinderoncologie B.V.0 个研究点目标入组 128 人开始时间: 2024年6月24日最近更新: 2024年8月21日

适应症

试验速览

暂无简介。

•Newly diagnosed with AML, Being registered and starting treatment according to the NOPHO-DBH AML 2012 study protocol, or a consecutive protocol, Age 0-19 years, Written informed consent by the patient and/or legal guardians (whatever applicable according to the patients’ age)

•Acute promyelocytic leukemia, Patients that are participating in another clinical study with an IMP, that interferes with the study objectives, Secondary AML, Down Syndrome, Preexisting primary immunodeficiency, Patients who receive regular antibiotic prophylaxis against Gram-positive bacteria for other conditions than leukemia-related, Patients with a history of an anaphylactic reaction (CTCAE1 grade =3) to teicoplanin and/or vancomycin, Patients with an eGFR49 of <30 ml/min/1.73m2 at the start of the study, Patients with a history of severe impaired hearing (CTCAE1 grade =3), Pregnant or breast-feeding patients

发起方

Prinses Maxima Centrum voor Kinderoncologie B.V.