Treatment EfficacyNCT05813951
Efficacy and Safety of Continuous Versus Intermittent Linezolid Infusion in Critically Ill Patients With Septic Shock
A study testing Linezolid in people with Treatment Efficacy, run by Ain Shams University at 1 site in Egypt.
Trial summary
The aim of study is this to evaluate the efficacy and safety of continuous linezolid infusion versus the standard regimen in treating critically ill patients with septic shock in the ICU Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Treatment Efficacy
- What is being tested?
- Linezolid
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteEgypt
- Study dates
- 2 Dec 2022to 2 Dec 2023
- 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
- adult patients aged > 18 years old
- diagnosis of septic shock (patient with septic shock can be clinically identified by a vasopressor requirement to maintain a mean arterial blood pressure of 65 mm Hg or greater and serum lactate level greater than 2 mmol\L (>18 mg\dL) in the absence of hypovolemia).
- positive culture confirming linezolid susceptibility.
Who cannot join
- Patient refusal.
- Known allergy to linezolid.
- Pregnancy and lactation.
- Severe hepatic failure (Child-Pugh C).
- Thrombocytopenia (platelet count < 80,000/mm3).
- Disseminated intravascular coagulation (DIC).
- Hematologic disease, and concurrent use of other medications that may interact with linezolid (i.e., macrolides, serotonin modulators), or drug-associated thrombocytopenia.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Ain Shams University
Cairo, 0060
ibrahim elsherif, MD, 01092286819 ext. 002, dribrahim.elsayed@med.asu.edu.eg
ahmed albadry, MD, 01119462809 ext. 002, goldbadry@yahoo.com
About this study
The aim of study is this to evaluate the efficacy and safety of continuous linezolid infusion versus the standard regimen in treating critically ill patients with septic shock in the ICU
Read the detailed description
it is Prospective randomized controlled study on One hundred forty patients to evaluate the efficacy and safety of continuous linezolid infusion versus the standard regimen in treating critically ill patients with septic shock in the ICU, Initially, each patient will be evaluated for septic shock based on the clinical criteria. Baseline microbiologic specimens will be obtained for all recruited patients through the day of diagnosis including blood C\&S. Then, empirical treatment with antibiotics according to expected source of sepsis. Patients with Gram-positive cultures sensitive to Linezolid will be randomly allocated to receive Linezolid in the continuous infusion group (Group A) or conventional intermittent infusion group (Group B) in a 1:1 ratio.
Group A: seventy Patients in the continuous infusion group will receive an intravenous loading dose of 600 mg for 60 min, followed by a continuous infusion of 1200 mg/day (50 mg/h).
Group B: seventy patients in the intermittent infusion group will administrate 600 mg of linezolid IV every 12 h for 60 min.
The treatment period will be 8-10 days in both groups but might decrease or increase based on the patients' clinical response. At the beginning of the study, simple randomization will be used to assign patients using the random numbers set offered by the ICU coordinator. Each patient will be assigned a randomized code consisting of two letters that indicate the intensive care unit and two digits indicating the randomization sequence.
The end point of the study is occurrence of thrombocytopenia (decrease in platelet count ≥ 50% from baseline or a decrease in platelet count ≤ 100 × 103/mm3).
- Conditions
- Treatment Efficacy
- Being tested
- Linezolid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LinezolidDrug
Also called zyvox
linezolid either continues infusion or standard intermittent dose
| Study group | Role | What they receive |
|---|---|---|
| continuous infusion | Active comparator | seventy Patients in the continuous infusion group will receive an intravenous loading dose of 600 mg of Linezolid for 60 min, followed by a continuous infusion of 1200 mg/day (50 mg/h) Receives: Drug: Linezolid |
| intermittent infusion | Active comparator | seventy patients in the intermittent infusion group will administrate 600 mg of linezolid IV every 12 h for 60 min Receives: Drug: Linezolid |
What is being measured
The primary outcome is the main question the study is designed to answer.
occurrence of medical cure
primary outcome defined as occurrence of medical cure on day 7 following linezolid initiation. Clinical cure will be indicated as normal body temperature(36.1 C- 37.2C).
Measured: 7 days
Secondary outcomes (1)
secondary outcomes
- ICU stay(days)
- duration of hospital stay (days).
- duration of linezolid treatment until clinical cure(days).
- Mortality at the end of treatment, and 30-day mortality.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2023
- Study start2 Dec 2022
- Primary completion2 Dec 2023 (estimated)
- Study completion2 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Treatment EfficacyStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- 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
- Prospective randomized controlled study
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ibrahim Elsayed, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05813951
- Sponsor's protocol ID
- FMASU R235/2022
- Status last verified
- Apr 2023
- First submitted
- 14 Feb 2023
- Last updated
- 14 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Continuous Versus Intermittent Linezolid Infusion in Critically Ill Patients With Septic Shock
- ClinicalTrials.gov ID
- NCT05813951
- Acronym / sponsor ID
- FMASU R235/2022
- Conditions
- Treatment Efficacy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 2 Dec 2022 (actual)
- Primary completion
- 2 Dec 2023 (estimated)
- Study completion
- 2 Dec 2023 (estimated)
- First posted
- 14 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 aim of study is this to evaluate the efficacy and safety of continuous linezolid infusion versus the standard regimen in treating critically ill patients with septic shock in the ICU
Detailed description
it is Prospective randomized controlled study on One hundred forty patients to evaluate the efficacy and safety of continuous linezolid infusion versus the standard regimen in treating critically ill patients with septic shock in the ICU, Initially, each patient will be evaluated for septic shock based on the clinical criteria. Baseline microbiologic specimens will be obtained for all recruited patients through the day of diagnosis including blood C\&S. Then, empirical treatment with antibiotics according to expected source of sepsis. Patients with Gram-positive cultures sensitive to Linezolid will be randomly allocated to receive Linezolid in the continuous infusion group (Group A) or conventional intermittent infusion group (Group B) in a 1:1 ratio.
Group A: seventy Patients in the continuous infusion group will receive an intravenous loading dose of 600 mg for 60 min, followed by a continuous infusion of 1200 mg/day (50 mg/h).
Group B: seventy patients in the intermittent infusion group will administrate 600 mg of linezolid IV every 12 h for 60 min.
The treatment period will be 8-10 days in both groups but might decrease or increase based on the patients' clinical response. At the beginning of the study, simple randomization will be used to assign patients using the random numbers set offered by the ICU coordinator. Each patient will be assigned a randomized code consisting of two letters that indicate the intensive care unit and two digits indicating the randomization sequence.
The end point of the study is occurrence of thrombocytopenia (decrease in platelet count ≥ 50% from baseline or a decrease in platelet count ≤ 100 × 103/mm3).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- Prospective randomized controlled study
| Arm | Type | Receives |
|---|---|---|
| continuous infusion | Active comparator | Drug: Linezolidseventy Patients in the continuous infusion group will receive an intravenous loading dose of 600 mg of Linezolid for 60 min, followed by a continuous infusion of 1200 mg/day (50 mg/h) |
| intermittent infusion | Active comparator | Drug: Linezolidseventy patients in the intermittent infusion group will administrate 600 mg of linezolid IV every 12 h for 60 min |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- adult patients aged > 18 years old
- diagnosis of septic shock (patient with septic shock can be clinically identified by a vasopressor requirement to maintain a mean arterial blood pressure of 65 mm Hg or greater and serum lactate level greater than 2 mmol\L (>18 mg\dL) in the absence of hypovolemia).
- positive culture confirming linezolid susceptibility.
Key exclusion criteria (7 listed)
- Patient refusal.
- Known allergy to linezolid.
- Pregnancy and lactation.
- Severe hepatic failure (Child-Pugh C).
- Thrombocytopenia (platelet count < 80,000/mm3).
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 |
|---|---|---|
| LinezolidAlso: zyvoxlinezolid either continues infusion or standard intermittent dose | Drug | continuous infusion, intermittent infusion |
Primary outcome
occurrence of medical cure
Time frame: 7 days
primary outcome defined as occurrence of medical cure on day 7 following linezolid initiation. Clinical cure will be indicated as normal body temperature(36.1 C- 37.2C).
1 secondary outcome
secondary outcomes
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2023.
- 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.
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 in people with Treatment Efficacy, run by Ain Shams University at 1 site in Egypt.
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 3 inclusion and 7 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 14 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 Egypt. 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 ibrahim elsherif, MD (01092286819 ext. 002, dribrahim.elsayed@med.asu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
occurrence of medical cure (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Apr 2023.