NL-OMON29284
Recruiting
Not Applicable
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 sites130 target enrollmentTBD
Conditions(Pediatric) Acute myeloid leukemia
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- (Pediatric) Acute myeloid leukemia
- Sponsor
- Princess Máxima Center for Pediatric Oncology
- Enrollment
- 130
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
Peer-reviewed international journals
Investigators
Eligibility Criteria
Inclusion Criteria
- •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)
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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