2023-506546-23-00RecruitingPhase 3
Teicoplanin as Infection Prophylaxis in Pediatric Acute Myeloid Leukemia (Pro-Teico study)
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
Source: EU CTIS (euclinicaltrials.eu) · Last updated 16 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 128 (estimated)
- First submitted
- 24 Jun 2024
- Start date
- 20 May 2020
- Lead sponsor
- Prinses Maxima Centrum voor Kinderoncologie B.V.
- Diseases
- Acute myeloid leukemia, Childhood cancers
- EU CT number
- 2023-506546-23-00
- EudraCT number
- 2020-000508-13
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 128
- 15 sites in 4 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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)
Other
- 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
Who the study is looking for
- 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)
Age in the registry: - to 64 years · Sex: All · Does not accept healthy volunteers
Sites (15)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Universitair Ziekenhuis Gent | Gent | Belgium | Recruiting |
| UZ Leuven | Leuven | Belgium | Recruiting |
| Aarhus Universitetshospital | Aarhus N | Denmark | Recruiting |
| Rigshospitalet | Copenhagen Oe | Denmark | Recruiting |
| Hospital General Universitario Dr. Balmis | Alicante | Spain | Recruiting |
| Hospital Universitari Vall d'Hebron | Barcelona | Spain | Recruiting |
| Sant Joan De Deu Barcelona Hospital | Esplugues De Llobregat | Spain | Recruiting |
| Hospital Universitario La Paz | Madrid | Spain | Recruiting |
| Hospital Infantil Universitario Nino Jesus | Madrid | Spain | Recruiting |
| Hospital Universitario Regional de Málaga | Málaga | Spain | Recruiting |
| University Hospital Son Espases | Palma | Spain | Recruiting |
| Universidade De Santiago De Compostela | Santiago De Compostela | Spain | Recruiting |
| Hospital Universitario Y Politecnico La Fe | Valencia | Spain | Recruiting |
| Hospital Unviersitario Miguel Servet | Zaragoza | Spain | Recruiting |
| Prinses Maxima Centrum voor Kinderoncologie B.V. | Utrecht | Netherlands | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.