PneumoniaNCT04531332
Continuous Infusion of Linezolid Versus Intermittent Dosing in the Treatment of Nosocomial Pneumonia
A study testing Continuous infusion Linezolid and intermittent dosing linezolid in people with Pneumonia, run by October 6 University at 1 site in Egypt.
Trial summary
The investigator's goal in this study is to determine the clinical efficacy and safety of continuous infusion in comparison with standard intermittent infusion. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pneumonia
- What is being tested?
- Continuous infusion Linezolid and intermittent dosing linezolid
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 169 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Nov 2019to 15 Sep 2021
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients admitted to ICUs diagnosed as HAP or VAP
- Chest X-ray/ computed tomography showing new or progressive infiltrate.
- New onset of purulent sputum or change in sputum character.
- Body temperature greater than 38 ℃ or less than 35.5℃.
- White blood cell counts greater than 10000 /mm3 or less than 4000 /mm3.
- Significant quantitative pathogen cultures from respiratory secretions.
Who cannot join
- Age <18 years, Pregnancy, Lactation
- Previous known allergic reaction to linezolid
- Creatinine Clearance (CrCl) <10 mL/min, calculated according to the Cockcroft-Gault formula
- Thrombocytopenia (platelet count less than 80,000/mm3)
- Severe hepatic failure (Child-Pugh C)
- Concomitant treatment with other drugs that can potentially interfere with Linezolid (i.e., macrolides, serotonin modulators, omeprazole)
- Acute DIC score > 4 points or hematological disorder
- Concurrent drug-associated Thrombocytopenia
Trial locations and contacts
1 site in 1 country.
Rania M Sarhan, PhD contact
Egypt1 site, 1 recruiting
- Recruiting
Beni-suef University
Banī Suwayf
Ahmed E Abou Warda, BSc, 00201007647696, ahmed.essam@o6u.edu.eg
Rania M Soliman, Ph.D
About this study
Official title: Efficacy and Safety of Continuous Infusion of Linezolid Compared With Intermittent Dosing in Critically Ill Pneumonic Patients
The investigator's goal in this study is to determine the clinical efficacy and safety of continuous infusion in comparison with standard intermittent infusion.
Read the detailed description
Prospective randomized controlled clinical trial on critically ill Pneumonic patients, included two groups, over one year period. The first group will be administered intravenous (IV) linezolid 600mg twice daily. The second group will be prescribed linezolid (IV) 600 mg loading dose followed by 1200 mg by continuous infusion. Both groups will be co-administered intravenous (IV) Meropenem 1g every 8 hours empirically.
- Conditions
- Pneumonia
- Being tested
- Continuous infusion Linezolid, intermittent dosing linezolid
- Keywords
- linezolid continuous infusion, pneumonia, critically ill patients
- Medical subject headings
- Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous infusion LinezolidDrug
Also called intervention
Linezolid 600 mg intravenous Loading dose followed by 1200 mg/ day by Continuous infusion ( 50 mg /hr )
intermittent dosing linezolidDrug
Also called control
Linezolid 600 mg intravenous twice daily
| Study group | Role | What they receive |
|---|---|---|
| Continuous infusion | Experimental | Patients will be received linezolid 600 mg intravenous Loading dose over 30 to 60 minutes followed by 1200 mg/ day by Continuous infusion (50 mg /hr) Receives: Drug: Continuous infusion Linezolid |
| Intermittent dosing | Active comparator | Patients will be received Linezolid 600 mg intravenous twice daily over 30 to 60 minutes Receives: Drug: intermittent dosing linezolid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of cured patients in the linezolid continuous infusion group versus the proportion of cured patients in the intermittent group
The primary efficacy endpoint will be evaluated as clinical cure on day 7 of Linezolid initiation.
Clinical cure defined by normalized body temperature, TLC less than 10,000/mL, absence of purulent secretions, and improvement of radiological findings (x-ray), in addition to Pao2/Fio2 greater than 250 in patients.
Measured: through study completion, over one year
Percentage of occurrence of anemia and thrombocytopenia
The patients' hematological parameters (hemoglobin (Hb), hematocrit (Hct), and platelets (PLTs) counts) will be compared every 2 days during linezolid treatment between two groups.
Anemia is defined as decrease in hemoglobin level <10 g/dl and Thrombocytopenia is defined as decrese in platelets count <100 × 103/mm3
Measured: through study completion, over one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2020
- Study start15 Nov 2019
- Primary completion15 Sep 2021 (estimated)
- Study completion15 Sep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PneumoniaStudies 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
- Masking
- None (open label)
- Enrolment
- 169 participants (estimated)
Sponsor and investigators
- Lead sponsor
- October 6 University
- Sponsor type
- University, hospital or other
- Collaborators
- Beni-Suef University
- Responsible party
- Principal investigator, Ahmed Essam, October 6 University
- Investigators
- Ahmed Essam, BSc, Principal investigator, October 6 University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04531332
- Sponsor's protocol ID
- REC-H-PhBSU-20004
- Status last verified
- Sep 2021
- First submitted
- 30 Jul 2020
- Last updated
- 16 Sep 2021
- 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 16 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Continuous Infusion of Linezolid Compared With Intermittent Dosing in Critically Ill Pneumonic Patients
- ClinicalTrials.gov ID
- NCT04531332
- Acronym / sponsor ID
- REC-H-PhBSU-20004
- Conditions
- Pneumonia
- Keywords
- linezolid continuous infusion, pneumonia, critically ill patients
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 169 participants (estimated)
- Lead sponsor
- October 6 UniversityUniversity, hospital or other
- Collaborators
- Beni-Suef University
- Study start
- 15 Nov 2019 (actual)
- Primary completion
- 15 Sep 2021 (estimated)
- Study completion
- 15 Sep 2021 (estimated)
- First posted
- 28 Aug 2020 (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 investigator's goal in this study is to determine the clinical efficacy and safety of continuous infusion in comparison with standard intermittent infusion.
Detailed description
Prospective randomized controlled clinical trial on critically ill Pneumonic patients, included two groups, over one year period. The first group will be administered intravenous (IV) linezolid 600mg twice daily. The second group will be prescribed linezolid (IV) 600 mg loading dose followed by 1200 mg by continuous infusion. Both groups will be co-administered intravenous (IV) Meropenem 1g every 8 hours empirically.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Continuous infusion | Experimental | Drug: Continuous infusion LinezolidPatients will be received linezolid 600 mg intravenous Loading dose over 30 to 60 minutes followed by 1200 mg/ day by Continuous infusion (50 mg /hr) |
| Intermittent dosing | Active comparator | Drug: intermittent dosing linezolidPatients will be received Linezolid 600 mg intravenous twice daily over 30 to 60 minutes |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients admitted to ICUs diagnosed as HAP or VAP
- Chest X-ray/ computed tomography showing new or progressive infiltrate.
- New onset of purulent sputum or change in sputum character.
- Body temperature greater than 38 ℃ or less than 35.5℃.
- White blood cell counts greater than 10000 /mm3 or less than 4000 /mm3.
Key exclusion criteria (8 listed)
- Age <18 years, Pregnancy, Lactation
- Previous known allergic reaction to linezolid
- Creatinine Clearance (CrCl) <10 mL/min, calculated according to the Cockcroft-Gault formula
- Thrombocytopenia (platelet count less than 80,000/mm3)
- Severe hepatic failure (Child-Pugh C)
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 |
|---|---|---|
| Continuous infusion LinezolidAlso: interventionLinezolid 600 mg intravenous Loading dose followed by 1200 mg/ day by Continuous infusion ( 50 mg /hr ) | Drug | Continuous infusion |
| intermittent dosing linezolidAlso: controlLinezolid 600 mg intravenous twice daily | Drug | Intermittent dosing |
Primary outcome
Proportion of cured patients in the linezolid continuous infusion group versus the proportion of cured patients in the intermittent group
Time frame: through study completion, over one year
The primary efficacy endpoint will be evaluated as clinical cure on day 7 of Linezolid initiation. Clinical cure defined by normalized body temperature, TLC less than 10,000/mL, absence of purulent secretions, and improvement of radiological findings (x-ray), in addition to Pao2/Fio2 greater than 250 in patients.
Percentage of occurrence of anemia and thrombocytopenia
Time frame: through study completion, over one year
The patients' hematological parameters (hemoglobin (Hb), hematocrit (Hct), and platelets (PLTs) counts) will be compared every 2 days during linezolid treatment between two groups. Anemia is defined as decrease in hemoglobin level <10 g/dl and Thrombocytopenia is defined as decrese in platelets count <100 × 103/mm3
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2021.
- 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.
Rania M Sarhan, PhD contact
Ahmed Essam, BSc principal investigator
October 6 University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Continuous infusion Linezolid and intermittent dosing linezolid in people with Pneumonia, run by October 6 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 6 inclusion and 8 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 16 Sep 2021. 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 Ahmed E Abou warda, BSc (00201007647696, ahmed.essam@o6u.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of cured patients in the linezolid continuous infusion group versus the proportion of cured patients in the intermittent group (time frame: through study completion, over one year). The study lists 2 primary outcomes in all. 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 16 Sep 2021.