Teicoplanin as Infection Prophylaxis in Pediatric Acute Myeloid Leukemia (Pro-Teico study)
Key facts
- Where
- Alicante, Barcelona, Esplugues De Llobregat, Madrid, Málaga, Palma, Santiago De Compostela, Valencia és Zaragoza, SpanyolországSee the 10 sites
- Phase
- 3. fázis
Where in Spanyolország
- Hospital General Universitario Dr. BalmisAlicante, SpanyolországTaking people
- Hospital Universitari Vall d'HebronBarcelona, SpanyolországTaking people
- Sant Joan De Deu Barcelona HospitalEsplugues De Llobregat, SpanyolországTaking people
- Hospital Infantil Universitario Nino JesusMadrid, SpanyolországTaking people
- Hospital Universitario La PazMadrid, SpanyolországTaking people
- Hospital Universitario Regional de MálagaMálaga, SpanyolországTaking people
- University Hospital Son EspasesPalma, SpanyolországTaking people
- Universidade De Santiago De CompostelaSantiago De Compostela, SpanyolországTaking people
- Hospital Universitario Y Politecnico La FeValencia, SpanyolországTaking people
- Hospital Unviersitario Miguel ServetZaragoza, SpanyolországTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Prinses Maxima Centrum voor Kinderoncologie B.V.
- Trial code
- EU 2023-506546-23-00
- Record updated
- 2026. október 16.
- Original description
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.Read full original descriptionShow less
Teicoplanin as Infection Prophylaxis in Pediatric Acute Myeloid Leukemia (Pro-Teico study) An open-label, randomized clinical trial on teicoplanin infection prophylaxis in pediatric patients with acute myeloid leukemia
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.
Inclusion: 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: Down Syndrome; 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 a history of severe impaired hearing (CTCAE1 grade ≥3); Acute promyelocytic leukemia; Patients that are participating in another clinical study with an IMP, that interferes with the study objectives; Secondary AML; Preexisting primary immunodeficiency; Patients with an eGFR49 of <30 ml/min/1.73m2 at the start of the study; Pregnant or breast-feeding patients.