Side-effect of AntibioticNCT05801484
Pharmacokinetics and Pharmacodynamics of Linezolid Continuous and Intermittent Administration
A study testing Linezolid continuous infusion in people with Side-effect of Antibiotic and Efficacy, run by Cluj Municipal Clinical Hospital at 1 site in Romania.
Trial summary
The purpose of this study is to evaluate the therapeutic efficacy expressed in pharmacokinetic/pharmacodynamic (PK/PD) indices, the clinical response and the risk of adverse reactions following the continuous and intermittent administration of linezolid in critical patients in the Intensive Care Unit. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Side-effect of Antibiotic, Efficacy, Pharmacokinetics
- What is being tested?
- Linezolid continuous infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteRomania
- Study dates
- 1 Jul 2022to 30 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients hospitalized in the intensive care unit,
- female or male sex,
- age over 18 years,
- linezolid is prescribed by the attending physician, in empirical treatment or based on the antibiogram.
Who cannot join
- documented severe liver failure (Child-Pugh C).
- no informed consent signed
Trial locations and contacts
1 site in 1 country.
Romania1 site, 1 recruiting
- Recruiting
University Clinical Municipal Hospital
Cluj-Napoca, Cluj, 400139
Ligia A Hui, PharmD, +40740385801, ligiahui@yahoo.com
Constantin Bodolea, MD, +40726133845, cbodolea@gmail.com
About this study
Official title: Continuous Infusion Versus Intermittent Administration of Linezolid - Impact on Clinical Outcome and Adverse Reactions in Critically Ill Patients: a Pharmacokinetic and Pharmacodynamic Prospective Study
The purpose of this study is to evaluate the therapeutic efficacy expressed in pharmacokinetic/pharmacodynamic (PK/PD) indices, the clinical response and the risk of adverse reactions following the continuous and intermittent administration of linezolid in critical patients in the Intensive Care Unit.
Subject inclusion criteria:
Read more
A minimum of 30 subjects in each group will be included in the study, in accordance with the study inclusion criteria:
- patients hospitalized in the intensive care unit,
- female or male sex,
- age over 18 years,
- linezolid is prescribed by the attending physician, in empirical or targeted treatment
Exclusion criteria:
Patients who have documented severe liver failure (Child-Pugh C score). Patients who refuse to sign the informed consent
Read the detailed description
The clinical study will be conducted in accordance with the protocol approved by the Ethics Commission of the "I.Haţieganu" University of Medicine and Pharmacy and the Ethics Commission of the Municipal Clinical Hospital, from Cluj-Napoca, in accordance with the rules of good clinical study practice.
The study will take place on the Intensive Care Unit of University Clinical Municipal Hospital from Cluj-Napoca, Romania. The analysis of blood drug concentration will be carried out at University of Medicine and Pharmacy 'Iuliu Hatieganu', Pharmacokinetics and Biopharmacy Laboratory, from Cluj-Napoca, Romania.
The objectives of the study are:
- Determination and the comparison of the pharmacokinetic and pharmacodynamic parameters of linezolid administration following intermittent infusion or continuous infusion, in critically ill patients.
- Determination of the minimum inhibitory concentrations (MIC) for linezolid for the identified bacteria (Staphylococcus aureus, Coagulase-Negative Staphylococcus, Enterococcus spp., Streptococcus pneumoniae).
The study will be conducted in the ICU Department of the Municipal Clinical Hospital in Cluj-Napoca, Romania, following an open, prospective, randomized design, with two groups of patients (group with intermittent infusion and group with continuous infusion of the same daily dose of linezolid). The patients that will be included in each group will be the patients in need of intensive care who are prescribed linezolid by the attending physician, as empirical or targeted therapy.
Given the low light stability of the linezolid solution, the infusion bag will be protected with an opaque cover provided by the manufacturer throughout the infusion period. The administration will be carried out with the help of an infusomate.
The duration of the therapy will be established, for each patient, by the attending physician depending on the type, location and severity of the infection in accordance with the recommendations of the therapeutic guidelines.
Throughout the duration of the study, the subjects will receive the treatment according to the recommendations of the attending physician, regardless of the group they belong to, the only difference between the groups refers to the type of infusion used to administer linezolid.
Blood samples (10 samples) will be taken from each volunteer, according to the following schedule: immediately before the start of the infusion (T0) and at 1, 2, 4, 8, 12, 18, 24, 36, 48 hours from initiation of drug infusion. Then, a single daily sample will be taken until the end of the treatment. Blood samples will be used to determine plasma concentrations of linezolid.
The efficacy and safety of the treatment will be evaluated using clinical and paraclinical data which will be correlated with the pharmacokinetic parameters determined for each type of treatment (continuous infusion or intermittent infusion). The data will be recorded in a case report form without disclosing the identity of the patients (each patient will receive a code at the beginning of the study).
Each subject will be followed until discharge or a maximum of 30 days after initiation of therapy.
- Conditions
- Side-effect of Antibiotic, Efficacy, Pharmacokinetics, Critical Illness, Intensive Care Unit ICU
- Being tested
- Linezolid continuous infusion
- Keywords
- continuous infusion, intensive care unit, critically ill, linezolid, pharmacokinetics, pharmacodynamics
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Linezolid continuous infusionOther
Continuous infusion of 1200 mg linezolid in 24h, after an initial dose of 600 mg linezolid administered as one hour infusion
| Study group | Role | What they receive |
|---|---|---|
| Linezolid continuous infusion | Experimental | In the intervention arm, Linezolid is administered 600 mg as loading dose as an infusion lasting one hour (flow rate 300 ml/h), followed by continuous infusion of 1200 mg linezolid over 24 hours (flow rate 25 ml/h) which is immediately initiated. The continuous infusion is administered until the end of the treatment. Receives: Other: Linezolid continuous infusion |
| Linezolid Intermittent administration | Active comparator | In the comparator arm, 600 mg dose of Linezolid is administered as one-hour infusion (flow rate 300 ml/h). Two doses at 12-h intervals are infused until the end of the treatment. Receives: Other: Linezolid continuous infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Linezolid plasmatic concentrations
10 plasmatic concentrations in the first 48h of linezolid treatment, then 1 plasmatic concentration per day until the end of the treatment
Measured: first 2-14 days (during treatment)
Secondary outcomes (2)
Linezolid clinical efficacy
Number of patients with negative cultures after linezolid treatment. Number of patients with laboratory improvement of leucocytes, c reactive protein, procalcitonin after linezolid treatment
Measured: from day 1 to day 30 after therapy initiation
Linezolid adverse reactions
side effects that are described in the summary of the product that may be seen
Measured: from day 1 to day 30 after therapy initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2023
- Study start1 Jul 2022
- Primary completion30 Jun 2024 (estimated)
- Study completion30 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Side-effect of AntibioticStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- open, prospective, randomized design, with two groups of patients (group with intermittent administration and group with continuous administration of the same daily dose of linezolid).
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cluj Municipal Clinical Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Iuliu Hatieganu University of Medicine and Pharmacy
- Responsible party
- Principal investigator, Bodolea Constantin, Cluj Municipal Clinical Hospital
- Investigators
- Constantin Bodolea, MD, PhD, Principal investigator, University Of Medicine and Pharmacy Iuliu Hatieganu, Cluj NapocaLigia A Hui, PharmD, Principal investigator, University Of Medicine and Pharmacy Iuliu Hatieganu, Cluj NapocaAdina Popa, Prof PharmD, Study chair, University Of Medicine and Pharmacy Iuliu Hatieganu, Cluj NapocaLaurian Vlase, Prof, PharmD, Study chair, University Of Medicine and Pharmacy Iuliu Hatieganu, Cluj Napoca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05801484
- Sponsor's protocol ID
- 3/2022
- Status last verified
- Apr 2023
- First submitted
- 15 Nov 2022
- Last updated
- 6 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hui LA, Bodolea C, Vlase L, Hiriscau EI, Popa A. Linezolid Administration to Critically Ill Patients: Intermittent or Continuous Infusion? A Systematic Literature Search and Review. Antibiotics (Basel). 2022 Mar 24;11(4):436. doi: 10.3390/antibiotics11040436.
PubMed 35453188
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Infusion Versus Intermittent Administration of Linezolid - Impact on Clinical Outcome and Adverse Reactions in Critically Ill Patients: a Pharmacokinetic and Pharmacodynamic Prospective Study
- ClinicalTrials.gov ID
- NCT05801484
- Acronym / sponsor ID
- 3/2022
- Conditions
- Side-effect of Antibiotic, Efficacy, Pharmacokinetics, Critical Illness, Intensive Care Unit ICU
- Keywords
- continuous infusion, intensive care unit, critically ill, linezolid, pharmacokinetics, pharmacodynamics
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Cluj Municipal Clinical HospitalUniversity, hospital or other
- Collaborators
- Iuliu Hatieganu University of Medicine and Pharmacy
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 30 Jul 2024 (estimated)
- First posted
- 6 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the therapeutic efficacy expressed in pharmacokinetic/pharmacodynamic (PK/PD) indices, the clinical response and the risk of adverse reactions following the continuous and intermittent administration of linezolid in critical patients in the Intensive Care Unit.
Subject inclusion criteria:
A minimum of 30 subjects in each group will be included in the study, in accordance with the study inclusion criteria:
- patients hospitalized in the intensive care unit,
- female or male sex,
- age over 18 years,
- linezolid is prescribed by the attending physician, in empirical or targeted treatment
Exclusion criteria:
Patients who have documented severe liver failure (Child-Pugh C score). Patients who refuse to sign the informed consent
Detailed description
The clinical study will be conducted in accordance with the protocol approved by the Ethics Commission of the "I.Haţieganu" University of Medicine and Pharmacy and the Ethics Commission of the Municipal Clinical Hospital, from Cluj-Napoca, in accordance with the rules of good clinical study practice.
The study will take place on the Intensive Care Unit of University Clinical Municipal Hospital from Cluj-Napoca, Romania. The analysis of blood drug concentration will be carried out at University of Medicine and Pharmacy 'Iuliu Hatieganu', Pharmacokinetics and Biopharmacy Laboratory, from Cluj-Napoca, Romania.
The objectives of the study are:
- Determination and the comparison of the pharmacokinetic and pharmacodynamic parameters of linezolid administration following intermittent infusion or continuous infusion, in critically ill patients.
- Determination of the minimum inhibitory concentrations (MIC) for linezolid for the identified bacteria (Staphylococcus aureus, Coagulase-Negative Staphylococcus, Enterococcus spp., Streptococcus pneumoniae).
The study will be conducted in the ICU Department of the Municipal Clinical Hospital in Cluj-Napoca, Romania, following an open, prospective, randomized design, with two groups of patients (group with intermittent infusion and group with continuous infusion of the same daily dose of linezolid). The patients that will be included in each group will be the patients in need of intensive care who are prescribed linezolid by the attending physician, as empirical or targeted therapy.
Given the low light stability of the linezolid solution, the infusion bag will be protected with an opaque cover provided by the manufacturer throughout the infusion period. The administration will be carried out with the help of an infusomate.
The duration of the therapy will be established, for each patient, by the attending physician depending on the type, location and severity of the infection in accordance with the recommendations of the therapeutic guidelines.
Throughout the duration of the study, the subjects will receive the treatment according to the recommendations of the attending physician, regardless of the group they belong to, the only difference between the groups refers to the type of infusion used to administer linezolid.
Blood samples (10 samples) will be taken from each volunteer, according to the following schedule: immediately before the start of the infusion (T0) and at 1, 2, 4, 8, 12, 18, 24, 36, 48 hours from initiation of drug infusion. Then, a single daily sample will be taken until the end of the treatment. Blood samples will be used to determine plasma concentrations of linezolid.
The efficacy and safety of the treatment will be evaluated using clinical and paraclinical data which will be correlated with the pharmacokinetic parameters determined for each type of treatment (continuous infusion or intermittent infusion). The data will be recorded in a case report form without disclosing the identity of the patients (each patient will receive a code at the beginning of the study).
Each subject will be followed until discharge or a maximum of 30 days after initiation of therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- open, prospective, randomized design, with two groups of patients (group with intermittent administration and group with continuous administration of the same daily dose of linezolid).
| Arm | Type | Receives |
|---|---|---|
| Linezolid continuous infusion | Experimental | Other: Linezolid continuous infusionIn the intervention arm, Linezolid is administered 600 mg as loading dose as an infusion lasting one hour (flow rate 300 ml/h), followed by continuous infusion of 1200 mg linezolid over 24 hours (flow rate 25 ml/h) which is immediately initiated. The continuous infusion is administered until the end of the treatment. |
| Linezolid Intermittent administration | Active comparator | Other: Linezolid continuous infusionIn the comparator arm, 600 mg dose of Linezolid is administered as one-hour infusion (flow rate 300 ml/h). Two doses at 12-h intervals are infused until the end of the treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- patients hospitalized in the intensive care unit,
- female or male sex,
- age over 18 years,
- linezolid is prescribed by the attending physician, in empirical treatment or based on the antibiogram.
Key exclusion criteria (2 listed)
- documented severe liver failure (Child-Pugh C).
- no informed consent signed
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Linezolid continuous infusionContinuous infusion of 1200 mg linezolid in 24h, after an initial dose of 600 mg linezolid administered as one hour infusion | Other | Linezolid Intermittent administration, Linezolid continuous infusion |
Primary outcome
Linezolid plasmatic concentrations
Time frame: first 2-14 days (during treatment)
10 plasmatic concentrations in the first 48h of linezolid treatment, then 1 plasmatic concentration per day until the end of the treatment
2 secondary outcomes
Linezolid clinical efficacy
Time frame: from day 1 to day 30 after therapy initiation
Linezolid adverse reactions
Time frame: from day 1 to day 30 after therapy initiation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2023.
- Background: PubMed 35453188Hui LA, Bodolea C, Vlase L, Hiriscau EI, Popa A. Linezolid Administration to Critically Ill Patients: Intermittent or Continuous Infusion? A Systematic Literature Search and Review. Antibiotics (Basel). 2022 Mar 24;11(4):436. doi: 10.3390/antibiotics11040436.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Constantin Bodolea, MD, PhD principal investigator
University Of Medicine and Pharmacy Iuliu Hatieganu, Cluj Napoca
Ligia A Hui, PharmD principal investigator
University Of Medicine and Pharmacy Iuliu Hatieganu, Cluj Napoca
Adina Popa, Prof PharmD study chair
University Of Medicine and Pharmacy Iuliu Hatieganu, Cluj Napoca
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Linezolid continuous infusion in people with Side-effect of Antibiotic and Efficacy, run by Cluj Municipal Clinical Hospital at 1 site in Romania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Romania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Constantin Bodolea, MD, PhD (+40726133845, cbodolea@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Linezolid plasmatic concentrations (time frame: first 2-14 days (during treatment)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05801484, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2023.