Teicoplanin as Infection Prophylaxis in Pediatric Acute Myeloid Leukemia
- Conditions
- (Pediatric) Acute myeloid leukemia
- Registration Number
- NL-OMON29284
- Lead Sponsor
- Princess Máxima Center for Pediatric Oncology
- Brief Summary
Peer-reviewed international journals
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 130
•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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary endpoint of the safety run-in is the number of DLTs. The primary endpoint of the randomized phase is the (first) occurrence of a culture-proven BSI with VGS during initial AML treatment. <br>
- Secondary Outcome Measures
Name Time Method