BridgeMD
Teicoplanin as Infection Prophylaxis in Pediatric Acute Myeloid Leukemia (Pro-Teico study)
EU CTIS ID: 2023-506546-23-00
What this study is testing
For safety run in phase: To assess the safety of i.v. teicoplanin prophylaxis three times per week with a two to three days interval in children with newly-diagnosed AML. For randomized control phase: To evaluate whether i.v. teicoplanin prophylaxis in children with newly-diagnosed AML decreases the occurrence of culture-proven BSIs with VGS during treatment.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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)
You likely can't join if
- 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
See the full eligibility 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)
- 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 0-17 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.