An open-label, randomized clinical trial on teicoplanin infection prophylaxis in pediatric patients with acute myeloid leukemia
- Conditions
- AML10024324blood cancer
- Registration Number
- NL-OMON54113
- Lead Sponsor
- Prinses Máxima Centrum voor Kinderoncologie
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 55
- 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 an anaphylactic 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
- Patients that are participating in another clinical study with an IMP, that
interferes with the study objectives.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Safety run-in:<br /><br>The number of DLTs observed.<br /><br><br /><br>Randomized controlled trial:<br /><br>The (first) occurrence of culture-proven BSIs with VGS during initial AML<br /><br>treatment;<br /><br>Date(s) of BSI(s) with VGS</p><br>
- Secondary Outcome Measures
Name Time Method