Safety and efficacy of teicoplanin as infection prophylaxis in pediatric patients with newly-diagnosed acute myeloid leukemia in order to decrease the occurrence of culture-proven Viridans Group Streptococcal sepsis during initial treatment: a prospective, international, multicenter, open-label, randomized clinical trial, preceded by a safety run-in.

Princess Máxima Center for Pediatric Oncology0 个研究点目标入组 130 人开始时间: 待定最近更新: 2024年2月28日

适应症

试验速览

Peer-reviewed international journals

•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
•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 a severe allergic reaction (CTCAE grade =3) to teicoplanin and/or vancomycin
•Patients with an eGFR of <30 ml/min/1.73m2 at the start of the study
•Patients with a history of severe impaired hearing (CTCAE grade =3)
•Pregnant or breast-feeding patients

发起方

Princess Máxima Center for Pediatric Oncology