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Model-informed precision dosing for linezolid: a randomized clinical trial
EU CTIS ID: 2024-517888-23-00
What this study is testing
To determine whether model-informed precision dosing optimizes linezolid dosing in order to better achieve a therapeutic trough concentration compared to standard dosing.
- 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
- Adult trial participants a) ≥ 18 years of age b) Linezolid treatment is indicated or has been started due to pneumonia, skin or soft tissue infection; the patient has received no more than 2 infusions of 600 mg linezolid each
- Participation a) with written informed consent of the patient or, Alternatively, but only if the patient is temporarily incapable of giving informed consent b) with written informed consent of his/her legally designated representative or c) after using the option of inclusion via spouse according to § 1358 BGB or d) according to article 35 of the CTR and with obtaining the patients informed consent as soon as possible
- Patients with potential childbearing ability: negative pregnancy test
You likely can't join if
- Infection other than pneumonia, skin or soft tissue infection, especially tuberculosis, endocarditis and osteomyelitis
- Concomitant treatment with monoamine oxidase inhibitors (e.g. phenelzine, isocarboxazid, tranylcypromine, moclobemide or selegiline)
- Patients whose life expectancy is less than 7 days
- Pregnancy
- Lactation/breastfeeding
- Previous participation in this study
See the full eligibility criteria
- Adult trial participants a) ≥ 18 years of age b) Linezolid treatment is indicated or has been started due to pneumonia, skin or soft tissue infection; the patient has received no more than 2 infusions of 600 mg linezolid each
- Participation a) with written informed consent of the patient or, Alternatively, but only if the patient is temporarily incapable of giving informed consent b) with written informed consent of his/her legally designated representative or c) after using the option of inclusion via spouse according to § 1358 BGB or d) according to article 35 of the CTR and with obtaining the patients informed consent as soon as possible
- Patients with potential childbearing ability: negative pregnancy test
- Infection other than pneumonia, skin or soft tissue infection, especially tuberculosis, endocarditis and osteomyelitis
- Concomitant treatment with monoamine oxidase inhibitors (e.g. phenelzine, isocarboxazid, tranylcypromine, moclobemide or selegiline)
- Patients whose life expectancy is less than 7 days
- Pregnancy
- Lactation/breastfeeding
- Previous participation in this study
- Simultaneous participation or participation in the past 4 weeks in another clinical trial with other medicinal products
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, 65+ 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.