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Taking people in DenmarkPhase 3

Teicoplanin to Prevent Infections in Children with Acute Myeloid Leukemia

Tests teicoplanin, an antibiotic given by vein, to prevent bloodstream infections in children with leukemia.

Key facts

Who runs it
Prinses Maxima Centrum voor Kinderoncologie B.V.
Where
Aarhus N and Copenhagen Oe, DenmarkSee the 2 sitesAlso in 3 other countries, 13 sites
Registry title
Teicoplanin as Infection Prophylaxis in Pediatric Acute Myeloid Leukemia (Pro-Teico study)
Status
Recruiting
Phase
Phase 3
People taking part
128 people, planned
Started
20 May 2020
Expected to end
30 Jun 2028
Type of study
Interventional
Record updated
16 October 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for children and young people newly diagnosed with acute myeloid leukemia (AML) who are starting standard AML treatment. It tests teicoplanin given into a vein to prevent bloodstream infections.

Age
0-19 years
Sex
All sexes can join.
Disease stage
Newly diagnosed AML, starting treatment according to the NOPHO-DBH AML 2012 study protocol or a consecutive protocol.
Earlier treatment
People who regularly take antibiotics against Gram-positive bacteria for reasons other than leukemia cannot join.

Main reasons for not taking part

  • Acute promyelocytic leukemia
  • Secondary AML
  • Down Syndrome
  • Preexisting primary immunodeficiency
  • Pregnant or breast-feeding patients

The registry criteria, word for word

Show all 14 criteriaShow less

Who can take part

  • 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)

Who cannot take part

  • 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

Where in Denmark

Also in 3 other countries, 13 sites

  • Aarhus UniversitetshospitalAarhus N, DenmarkTaking people
  • RigshospitaletCopenhagen Oe, DenmarkTaking people

About the trial

What the trial wants to find out

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

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.

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record

Print a page for my doctor

Data and sources

Registry record
Listed on the EU's official list of trials (CTIS).
Official title
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
Plain-language title
Teicoplanin to Prevent Infections in Children with Acute Myeloid LeukemiaGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 9 November 2026.
Record updated
16 October 2026