Model‑informed precision dosing of linezolid in ICU patients with bacterial pneumonia, skin or soft‑tissue infection: a randomized clinical trial

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What is this study about?

The study looks at adults in the ICU who have a serious bacterial infection such as pneumonia or a skin or soft‑tissue infection that needs treatment with linezolid. The medication is given by intravenous infusion, which means it is delivered directly into a vein.

The purpose is to find out whether a model‑informed precision dosing approach can better achieve the desired blood level of the drug compared with the usual dosing schedule. Participants will be randomly assigned to receive either the standard dose or a dose that is adjusted using a computer model based on blood tests. Blood samples will be taken on Day 7 and later to see if the drug level is within the target range of 2‑8 mg/L, and safety signs such as low platelet counts or high lactate levels will be monitored.

The trial will continue for the period the patient receives the medication, with follow‑up until the end of the intensive care stay and hospital discharge. Information about the length of ICU stay, overall hospital stay, and any serious adverse events will be collected.

1 enrollment and consent

after joining the study you will sign a consent form that explains the purpose of the trial and what is expected of you.

your eligibility for the trial will be confirmed by the study team.

2 baseline assessments

initial medical history, physical examination, and routine laboratory tests will be performed.

samples from blood, respiratory tract, skin or other infected sites will be taken to identify the bacterial cause of infection.

3 randomization

you will be randomly assigned to either the standard dosing group or the model-informed precision dosing group.

the assignment will determine how your linezolid dose is managed during the trial.

4 start of linezolid treatment

you will receive linezolid by intravenous infusion at a total dose of 4800 mg per day.

the infusion is given once daily and will continue for the duration of the infection treatment as decided by your physician.

5 daily monitoring and safety checks

each day blood will be drawn to check for safety parameters such as platelet count and lactate level.

these tests help detect possible side effects like low platelets or elevated lactate, which can indicate toxicity.

6 trough concentration sampling on day 7

on day 7 a blood sample will be taken just before the next linezolid dose.

the laboratory will measure the trough concentration, which should be between 2 and 8 mg/L.

if the level is outside this range, the dose may be adjusted according to the model-informed dosing algorithm.

7 dose adjustment based on model-informed dosing

for participants in the precision dosing group, the measured trough level will be used by a computer model to calculate a personalized dose.

the new dose will be administered from the next infusion onward.

8 second trough concentration sampling on day 13

a second trough sample will be collected on day 13 to see if the target concentration is maintained.

the result may lead to another dose adjustment if needed.

9 ongoing microbiological monitoring

additional cultures may be taken during treatment and at the end of therapy to determine whether the infection has been cleared.

the presence or absence of gram‑positive bacteria resistant to linezolid will be recorded.

10 completion of linezolid therapy

treatment will continue until the physician decides that the infection is resolved or until a predefined maximum duration is reached.

you will be observed for any late side effects before the trial ends.

11 final assessment and study exit

at the end of therapy a final set of safety labs and microbiological tests will be performed.

you will be thanked for your participation and no further study procedures will be required.

Who Can Join the Study?

Be an adult (age ≥ 18 years).
Have a bacterial infection such as pneumonia (lung infection) or a skin/soft‑tissue infection that requires treatment with the antibiotic linezolid, and have received no more than two intravenous doses (each 600 mg) of the drug (an infusion means a dose given through a vein).
Provide written informed consent. If the patient cannot give consent at the time, written consent may be obtained from a legally authorized representative, a spouse under specific legal provisions, or the patient’s consent can be obtained later as required by the regulations.
If the patient could become pregnant, a recent negative pregnancy test must be documented.

Who Cannot Join the Study?

Having an infection that is not pneumonia or a skin or soft‑tissue infection; this includes infections such as tuberculosis (a bacterial disease that mainly affects the lungs), endocarditis (infection of the heart lining), or osteomyelitis (infection of the bone).
Taking any monoamine oxidase inhibitors (MAO‑I drugs such as phenelzine, isocarboxazid, tranylcypromine, moclobemide, or selegiline) at the same time, because these medicines can cause dangerous reactions when combined with linezolid.
Being expected to live less than 7 days (a life expectancy shorter than one week).
Being pregnant (carrying a developing baby).
Being in lactation or breastfeeding (providing milk to a baby).
Having already taken part in this same study before.
Being enrolled in another clinical trial right now or having taken part in another trial with different medicines within the past 4 weeks.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Uwupahgkys Mbunbvh Clfuyi Hcjouyddktqubsnpe	Hamburg	Germany

Trial status

Country	Status	Recruitment Start
Germany	Not yet recruiting	01.08.2026

Trial locations

Investigated Drugs:

Linezolid

LINEZOLID is an antibiotic that is given through a vein (intravenous infusion) to treat serious bacterial infections. In this trial, the drug is being studied to see if using a computer model to adjust the dose for each patient (model‑informed precision dosing) can help keep the medication level in the blood within the target range more reliably than the usual fixed dosing method. The goal is to improve the effectiveness of the treatment while reducing the risk of side effects.

Investigated Diseases:

Bacterial infection

Bacterial pneumonia – A bacterial pneumonia is an infection of the lung tissue caused by bacteria. It usually begins with a cough, fever, and difficulty breathing as the bacteria multiply in the air sacs. Over time the infection can cause the air sacs to fill with fluid, making breathing harder. The condition may spread to other parts of the lung if the bacteria are not cleared. Symptoms often increase in intensity before they start to improve as the body fights the infection.
Skin and soft tissue bacterial infection – This infection involves bacteria entering the skin or underlying tissues, often after a cut or wound. It typically starts with redness, swelling, warmth, and pain at the site. As the bacteria multiply, the area may become larger and may develop pus or an ulcer. If the infection spreads deeper, it can affect surrounding muscles and fascia, leading to increased discomfort. The affected area usually enlarges before the immune response begins to limit the spread.

Trial ID:

2024-517888-23-00

Protocol code:

ZKSJ0160_LineMAP

NCT ID:

NCT06444802

Trial Phase:

Therapeutic confirmatory (Phase III)

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Model‑informed precision dosing of linezolid in ICU patients with bacterial pneumonia, skin or soft‑tissue infection: a randomized clinical trial

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?