Thrombocytopenia; DrugsNCT05944445
The Incidence of Linezolid-induced Thrombocytopenia (LIT) in Critically Ill Patients, the Risk Factors for LIT
An observational study of Thrombocytopenia; Drugs, run by Helwan University at 1 site in Egypt.
Trial summary
To identify the incidence of LIT among critically ill patients, as limited studies have only addressed this population. To evaluate the impact of several factors on the incidence of LIT, the time to onset of LIT, and the time to recovery of platelets. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thrombocytopenia; Drugs
- What is being tested?
- Linezolid 600 mg
- Type of treatment
- Injection or infusion
- How many people
- 310 participants
- Where
- 1 siteEgypt
- Study dates
- 13 Jul 2023to Aug 2024
- Phase
- Observational
- 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
Study population: Adult critically ill patients admitted to ICU for different indications
Who may be able to join
- All adult patients, age > or = 18 years old, admitted to the ICU with different indications.
- candidates for intravenous linezolid therapy for > or =1 day.
Who cannot join
- Taking any myelosuppressive drug.
- Baseline platelets < 50000.
- Patients with hematological malignancy.
- COVID-19 patients.
- Patients with immune thrombocytopenia
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
15 May hospital
Cairo
Amina S Adly, Diploma, 00201559030055, Aminaosamaomar@gmail.com
About this study
Official title: The Incidence of Linezolid-induced Thrombocytopenia (LIT) in Critically Ill Patients, the Risk Factors for LIT and Time to Events (LIT, Recovery)
- To identify the incidence of LIT among critically ill patients, as limited studies have only addressed this population.
- To evaluate the impact of several factors on the incidence of LIT, the time to onset of LIT, and the time to recovery of platelets.
- To study the effect of concurrent medications (enoxaparin, unfractinated heparin, piperacillin, carbapenems, tigecycline, fluconazole or voriconazole, digoxin, amiodarone, acetaminophen, tirofiban, statins, and antiepileptics) frequently used in critically ill patients on the incidence of LIT.
- To investigate the impact of possible medications with an antioxidant effect on the prevention of LIT.
- To assess the impact of LIT on composite end point (mortality, bleeding, and length of stay)
- Conditions
- Thrombocytopenia; Drugs
- Being tested
- Linezolid 600 mg
- Keywords
- Linezolid, Thrombocytopenia
- Medical subject headings
- Thrombocytopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Linezolid 600 mgDrug
Linezolid 600mg injection
| Study group | Role | What they receive |
|---|---|---|
| Single arm group | Adult critically ill patients admitted to ICU for different indications Receives: Drug: Linezolid 600 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Linezolid-induced thrombocytopenia (LIT) thrombocytopenia
Defined as platelets < 150000 OR decrease > 50% of baseline platelets.
Measured: One year
Secondary outcomes (3)
Time to the onset of LIT
Defined as platelets < 150000 OR decrease > or = 50% of baseline platelets.
Measured: One year
time to platelet recovery
after having thrombocytopenia, regardless of discontinuation of linezolid, recovery is defined as the restoration and maintenance of platelet counts > 70% of baseline values
Measured: One year
Incidence of clinical outcomes
Incidence of clinical outcomes (bleeding, mortality, length of stay, need for platelet or blood transfusion).
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2023
- Study start13 Jul 2023
- Primary completionAug 2024 (estimated)
- Study completionAug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thrombocytopenia; DrugsStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 310 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Helwan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Abdeltawab, Helwan University
- Investigators
- Abdelhameed I Ebid, Study director, Helwan University, faculty of pharmacyMahmoud I Mostafa, Study director, Helwan University, faculty of pharmacy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05944445
- Sponsor's protocol ID
- 11041989
- Status last verified
- Jul 2023
- First submitted
- 6 Jul 2023
- Last updated
- 17 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Incidence of Linezolid-induced Thrombocytopenia (LIT) in Critically Ill Patients, the Risk Factors for LIT and Time to Events (LIT, Recovery)
- ClinicalTrials.gov ID
- NCT05944445
- Acronym / sponsor ID
- 11041989
- Conditions
- Thrombocytopenia; Drugs
- Keywords
- Linezolid, Thrombocytopenia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 310 participants (estimated)
- Lead sponsor
- Helwan UniversityUniversity, hospital or other
- Study start
- 13 Jul 2023 (actual)
- Primary completion
- Aug 2024 (estimated)
- Study completion
- Aug 2024 (estimated)
- First posted
- 13 Jul 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.
- To identify the incidence of LIT among critically ill patients, as limited studies have only addressed this population.
- To evaluate the impact of several factors on the incidence of LIT, the time to onset of LIT, and the time to recovery of platelets.
- To study the effect of concurrent medications (enoxaparin, unfractinated heparin, piperacillin, carbapenems, tigecycline, fluconazole or voriconazole, digoxin, amiodarone, acetaminophen, tirofiban, statins, and antiepileptics) frequently used in critically ill patients on the incidence of LIT.
- To investigate the impact of possible medications with an antioxidant effect on the prevention of LIT.
- To assess the impact of LIT on composite end point (mortality, bleeding, and length of stay)
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single arm group | – | Drug: Linezolid 600 mgAdult critically ill patients admitted to ICU for different indications |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult critically ill patients admitted to ICU for different indications
Key inclusion criteria (2 listed)
- All adult patients, age > or = 18 years old, admitted to the ICU with different indications.
- candidates for intravenous linezolid therapy for > or =1 day.
Key exclusion criteria (5 listed)
- Taking any myelosuppressive drug.
- Baseline platelets < 50000.
- Patients with hematological malignancy.
- COVID-19 patients.
- Patients with immune thrombocytopenia
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 600 mgLinezolid 600mg injection | Drug | Single arm group |
Primary outcome
Incidence of Linezolid-induced thrombocytopenia (LIT) thrombocytopenia
Time frame: One year
Defined as platelets < 150000 OR decrease > 50% of baseline platelets.
3 secondary outcomes
Time to the onset of LIT
Time frame: One year
time to platelet recovery
Time frame: One year
Incidence of clinical outcomes
Time frame: One year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2023.
- Individual participant dataSharing planned: Undecided
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.
Abdelhameed I Ebid study director
Helwan University, faculty of pharmacy
Mahmoud I Mostafa study director
Helwan University, faculty of pharmacy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thrombocytopenia; Drugs, run by Helwan 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 2 inclusion and 5 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 17 Jul 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 Amina S Adly, BCPS (00201559030055, Aminaosamaomar@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Linezolid-induced thrombocytopenia (LIT) thrombocytopenia (time frame: One year). 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 17 Jul 2023; AzTrials last refreshed its copy on 8 Nov 2026.