Study on Teicoplanin for Preventing Infections in Children with Acute Myeloid Leukemia

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What is this study about?

This clinical trial is focused on studying the use of teicoplanin as a preventive treatment for infections in children diagnosed with Acute Myeloid Leukemia (AML). Acute Myeloid Leukemia is a type of cancer that affects the blood and bone marrow, which is the spongy tissue inside bones where blood cells are made. The study aims to determine if using teicoplanin, a medication given through an injection into a vein, can help reduce the occurrence of certain infections during the treatment of children with newly diagnosed AML.

The study is divided into two phases. In the first phase, the safety of using teicoplanin three times a week will be assessed. In the second phase, the study will evaluate whether this treatment can decrease the occurrence of specific blood infections during the initial treatment of AML. Participants will receive the medication for a maximum period of four weeks. Some participants may receive a placebo, which is a substance with no active medication, to compare the effects of teicoplanin.

The trial will monitor various aspects, such as the number of infections, any side effects, and the overall health of the participants during the study. The goal is to gather information on how effective and safe teicoplanin is in preventing infections in children undergoing treatment for Acute Myeloid Leukemia.

1 joining the study

Participation begins after a diagnosis of acute myeloid leukemia (AML) and registration according to the NOPHO-DBH AML 2012 study protocol or a similar protocol.

Eligibility requires written informed consent from the patient or legal guardians, depending on the patient’s age.

2 safety run-in phase

The initial phase focuses on assessing the safety of intravenous (i.v.) teicoplanin as a preventive measure against infections.

The medication is administered three times per week with intervals of two to three days.

3 randomized control phase

This phase evaluates the effectiveness of i.v. teicoplanin in reducing the occurrence of specific bloodstream infections during AML treatment.

The primary goal is to monitor the first occurrence of a culture-proven bloodstream infection with viridans group streptococci (VGS).

4 medication details

The medication used is Targocid 400mg, a powder for solution for injection or infusion.

The administration route is intravenous, which involves delivering the medication directly into a vein.

5 monitoring and assessments

Regular monitoring includes checking for any adverse effects, such as changes in kidney function or hearing.

Blood cultures are taken to identify any resistant bacteria and to monitor infection-related outcomes.

6 end of trial

The trial is expected to conclude by November 30, 2025.

The duration of participation may vary depending on individual treatment responses and the occurrence of any adverse events.

Who Can Join the Study?

The patient must have been newly diagnosed with acute myeloid leukemia (AML).
The patient must be registered and starting treatment according to the NOPHO-DBH AML 2012 study protocol, or a similar protocol that follows consecutively.
The patient must be between the ages of 0 and 19 years.
There must be a written informed consent provided by the patient and/or their legal guardians, depending on the patient’s age. This means that the patient and/or their guardians understand the study and agree to participate.

Who Cannot Join the Study?

Patients who do not have a diagnosis of acute myeloid leukemia (a type of blood cancer) cannot participate.
Patients who are not within the specified age range for the study cannot participate.
Patients who are not part of the specified clinical trial group cannot participate.
Patients who are not considered part of the vulnerable population selected for the study cannot participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Hospital Universitario Y Politecnico La Fe	Valencia	Spain
Katholieke Universiteit te Leuven	Leuven	Belgium

Other Sites

Site Name	City	Country
Universitair Ziekenhuis Gent	Gent	Belgium
Hospital Sant Joan De Deu Barcelona	Esplugues De Llobregat	Spain
Universidade De Santiago De Compostela	Santiago De Compostela	Spain
Prinses Maxima Centrum voor Kinderoncologie B.V.	Utrecht	The Netherlands
Rigshospitalet	Copenhagen	Denmark
Servei De Salut De Les Illes Balears	Palma	Spain
Anppho Udxtaqwitu Hvmttust	Aarhus	Denmark
Fzwmarhsy Prov Lv Imjouyzciczpe Bwuchcpgm Dno Heifcnhi Utnpxtfjztlqh Lr Pae	Madrid	Spain
Hnygikgh Vibr dqbnqkej	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Belgium	Recruiting	21.05.2021
Denmark	Recruiting	21.05.2021
Spain	Recruiting	21.05.2021
The Netherlands	Recruiting	21.05.2021

Trial locations

Investigated drugs:

Teicoplanin

Teicoplanin is being studied as a preventive treatment for infections in children with newly diagnosed acute myeloid leukemia (AML). The trial aims to determine if using teicoplanin can reduce the occurrence of certain bloodstream infections during treatment. It is administered intravenously three times a week with intervals of two to three days.

Acute Myeloid Leukemia – Acute Myeloid Leukemia (AML) is a type of cancer that affects the blood and bone marrow, characterized by the rapid growth of abnormal white blood cells. These abnormal cells accumulate in the bone marrow, interfering with the production of normal blood cells. As the disease progresses, it can lead to symptoms such as fatigue, frequent infections, and easy bruising or bleeding due to the lack of healthy blood cells. AML can occur at any age but is more common in adults. The disease is classified into different subtypes based on specific genetic and chromosomal abnormalities. The progression of AML can vary, with some cases advancing quickly while others may develop more slowly.

Trial ID:

2023-506546-23-00

Protocol code:

SP_MH19PRO

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Teicoplanin for Preventing Infections in Children with Acute Myeloid Leukemia

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