Teicoplanin as Infection Prophylaxis in Pediatric Acute Myeloid Leukemia (Pro-Teico study)
- Conditions
- Acute myeloid leukemiaMedDRA version: 21.0Level: LLTClassification code: 10000886Term: Acute myeloid leukemia Class: 10029104Therapeutic area: Diseases [C] - Neoplasms [C04]
- Registration Number
- CTIS2023-506546-23-00
- Lead Sponsor
- Prinses Maxima Centrum voor Kinderoncologie B.V.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 128
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method