ThrombocytopaeniaLinezRenalNCT06761131
Compare Linezolid-Induced Thrombocytopenia in Patients With Normal Renal Function Versus Impaired Renal Function
An observational study of Thrombocytopaenia and Impaired Renal Function, run by Ain Shams University at 1 site in Egypt.
Trial summary
Linezolid exhibits a broad spectrum of activity against Gram-positive bacteria, including methicillin-resistant staphylococcus aureus (MRSA) and vancomycin-resistant enterococci. The major adverse effect associated with linezolid treatment is reversible myelosuppression, mostly thrombocytopenia. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Thrombocytopaenia, Impaired Renal Function
- What is being tested?
- Linezolid (LZD)
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 20 May 2024to 20 Jun 2025
- How long will I take part?
- 1 Week
- 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 to 60 years
- All sexes
- Adult
Study population: After obtaining approval from the research ethical committee of the Anesthesia, Intensive care and Pain management department, Ain Shams University; this study will be conducted in the ICUs of Ain Shams University Hospitals.
Who may be able to join
- Patients diagnosed with sepsis having 2 or more of the following criteria:
- Septic shock clinically identified by a vasopressor requirement to maintain a mean arterial blood pressure of 65 mm Hg or greater.
- Serum lactate level greater than 2 mmol\L.
- Positive culture confirming bacterial infection.
- Patients highly susceptible to infection by Gram-positive bacteria such as Nosocomial pneumonia, Community-acquired pneumonia, Complicated skin and soft tissue infections.
Who cannot join
- Patient or their legal guardian refuses to include their data in the study.
- Known allergy to linezolid.
- Pregnancy and lactation.
- Severe hepatic failure (Child-Pugh C as INR>2.3, Bilirubin>3mg/dl, Albumin<2.8gm/dl).
- Thrombocytopenia (platelet count < 80,000/mm3).
- Disseminated intravascular coagulation (DIC) as Fibrinogen<1g/L, PT more than 6 seconds increase above normal, high D Dimer level.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Study Between Incidence of Linezolid-Induced Thrombocytopenia in Patients With Normal Renal Function Versus Patients With Impaired Renal Function
Linezolid exhibits a broad spectrum of activity against Gram-positive bacteria, including methicillin-resistant staphylococcus aureus (MRSA) and vancomycin-resistant enterococci. The major adverse effect associated with linezolid treatment is reversible myelosuppression, mostly thrombocytopenia. Recent studies have reported that the incidence of linezolid-induced thrombocytopenia was higher among patients with renal failure than in patients with normal renal function, although the underlying mechanisms explaining this toxicity are still unknown.
Read the detailed description
Linezolid is an oxazolidinone antibiotic with the availability of intravenous and oral formulations. The latter has nearly 100% bioavailability and is expected to facilitate the treatment of infections caused by these organisms (Gram-positive bacteria).
In addition, linezolid has very favorable rates of penetration into tissues. This suggests a potential pharmacokinetic advantage of linezolid over glycopeptides in the treatment of deep-seated infections such as pneumonia and CNS infections.
Prolonged use of linezolid can lead to hematological side effects, particularly thrombocytopenia. Indeed, several studies have reported that the incidence of thrombocytopenia associated with linezolid therapy is much higher (7.5%-64.7%) than the incidence reported in an early clinical study (2.4%) conducted by the manufacturer.
Thrombocytopenia is a common complication in the intensive care unit (ICU), and its incidence ranges from 13 to 60 %.
Thrombocytopenia is defined as a platelet count of less than 100,000/μl or a decrease of at least 50 % from baseline. Thrombocytopenia can be characterized as mild (≥ 50,000/μl), moderate (30,000/μl to 50,000/μl) and severe (< 30,000/μl).
There are different causes of thrombocytopenia in critically ill patients: sepsis, severe malnutrition, neoplastic infiltration of bone marrow, radiation therapy, mechanical intravascular devices, autoimmune disorders, and the administration of heparin (heparin-induced thrombocytopenia, HIT).
Moreover, many drugs can cause thrombocytopenia. The incidence of drug-induced thrombocytopenia (DIT) is not well defined but is estimated to be at least ten cases per million per year.Its mechanisms can be divided into two categories: a decreased production through bone marrow suppression, or an increased destruction through an immune-mediated mechanism. Immune-mediated thrombocytopenia develops generally after 7-14 days of therapy, while non-immune-mediated thrombocytopenia tends to develop more gradually, over a few weeks. Recovery of platelet count occurs several days after disruption of drug administration in immune-mediated thrombocytopenia, while recovery from non immune DIT may take longer.
- Conditions
- Thrombocytopaenia, Impaired Renal Function
- Being tested
- Linezolid (LZD)
- Medical subject headings
- Thrombocytopenia, Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Linezolid (LZD)Drug
compare the incidence and magnitude of Linezolid induced thrombocytopenia
| Study group | Role | What they receive |
|---|---|---|
| Group N (will be with normal renal function) | Not described Receives: Drug: Linezolid (LZD) | |
| Group I (will be with impaired renal function) | Not described Receives: Drug: Linezolid (LZD) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The relationship between kidney function and the development of linezolidinduced thrombocytopenia
Measured: Through study completion, an average of 1 year the occurrence of severe thrombocytopenia < 30.000 that will indicate stop receiving medications that implicates in causing thrombocytopenia or transfer of the patient from ICU.
Secondary outcomes (1)
The duration of hospital stay or ICU stay or The incidence of the need for renal replacement therapy (RRT) during hospital stay.
Measured: Through study completion, an average of 1 year the occurrence of severe thrombocytopenia < 30.000 that will indicate stop receiving medications that implicates in causing thrombocytopenia or transfer of the patient from ICU.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2025
- Study start20 May 2024
- Primary completion20 May 2025
- Study completion20 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ThrombocytopaeniaStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
- Target duration
- 1 Week
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06761131
- Sponsor's protocol ID
- FMASU MD35/2024
- Acronym
- LinezRenal
- Status last verified
- Jul 2025
- First submitted
- 26 Dec 2024
- Last updated
- 25 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study Between Incidence of Linezolid-Induced Thrombocytopenia in Patients With Normal Renal Function Versus Patients With Impaired Renal Function
- ClinicalTrials.gov ID
- NCT06761131
- Acronym / sponsor ID
- LinezRenal / FMASU MD35/2024
- Conditions
- Thrombocytopaenia, Impaired Renal Function
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 20 May 2024 (actual)
- Primary completion
- 20 May 2025 (actual)
- Study completion
- 20 Jun 2025 (actual)
- First posted
- 7 Jan 2025 (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.
Linezolid exhibits a broad spectrum of activity against Gram-positive bacteria, including methicillin-resistant staphylococcus aureus (MRSA) and vancomycin-resistant enterococci. The major adverse effect associated with linezolid treatment is reversible myelosuppression, mostly thrombocytopenia. Recent studies have reported that the incidence of linezolid-induced thrombocytopenia was higher among patients with renal failure than in patients with normal renal function, although the underlying mechanisms explaining this toxicity are still unknown.
Detailed description
Linezolid is an oxazolidinone antibiotic with the availability of intravenous and oral formulations. The latter has nearly 100% bioavailability and is expected to facilitate the treatment of infections caused by these organisms (Gram-positive bacteria).
In addition, linezolid has very favorable rates of penetration into tissues. This suggests a potential pharmacokinetic advantage of linezolid over glycopeptides in the treatment of deep-seated infections such as pneumonia and CNS infections.
Prolonged use of linezolid can lead to hematological side effects, particularly thrombocytopenia. Indeed, several studies have reported that the incidence of thrombocytopenia associated with linezolid therapy is much higher (7.5%-64.7%) than the incidence reported in an early clinical study (2.4%) conducted by the manufacturer.
Thrombocytopenia is a common complication in the intensive care unit (ICU), and its incidence ranges from 13 to 60 %.
Thrombocytopenia is defined as a platelet count of less than 100,000/μl or a decrease of at least 50 % from baseline. Thrombocytopenia can be characterized as mild (≥ 50,000/μl), moderate (30,000/μl to 50,000/μl) and severe (< 30,000/μl).
There are different causes of thrombocytopenia in critically ill patients: sepsis, severe malnutrition, neoplastic infiltration of bone marrow, radiation therapy, mechanical intravascular devices, autoimmune disorders, and the administration of heparin (heparin-induced thrombocytopenia, HIT).
Moreover, many drugs can cause thrombocytopenia. The incidence of drug-induced thrombocytopenia (DIT) is not well defined but is estimated to be at least ten cases per million per year.Its mechanisms can be divided into two categories: a decreased production through bone marrow suppression, or an increased destruction through an immune-mediated mechanism. Immune-mediated thrombocytopenia develops generally after 7-14 days of therapy, while non-immune-mediated thrombocytopenia tends to develop more gradually, over a few weeks. Recovery of platelet count occurs several days after disruption of drug administration in immune-mediated thrombocytopenia, while recovery from non immune DIT may take longer.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Week
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group N (will be with normal renal function) | – | Drug: Linezolid (LZD) |
| Group I (will be with impaired renal function) | – | Drug: Linezolid (LZD) |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Age groups
- Adult
- Study population
- After obtaining approval from the research ethical committee of the Anesthesia, Intensive care and Pain management department, Ain Shams University; this study will be conducted in the ICUs of Ain Shams University Hospitals.
Key inclusion criteria (5 listed)
- Patients diagnosed with sepsis having 2 or more of the following criteria:
- Patients highly susceptible to infection by Gram-positive bacteria such as Nosocomial pneumonia, Community-acquired pneumonia, Complicated skin and soft tissue infections.
Key exclusion criteria (6 listed)
- Patient or their legal guardian refuses to include their data in the study.
- Known allergy to linezolid.
- Pregnancy and lactation.
- Severe hepatic failure (Child-Pugh C as INR>2.3, Bilirubin>3mg/dl, Albumin<2.8gm/dl).
- 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 |
|---|---|---|
| Linezolid (LZD)compare the incidence and magnitude of Linezolid induced thrombocytopenia | Drug | Group I (will be with impaired renal function), Group N (will be with normal renal function) |
Primary outcome
The relationship between kidney function and the development of linezolidinduced thrombocytopenia
Time frame: Through study completion, an average of 1 year the occurrence of severe thrombocytopenia < 30.000 that will indicate stop receiving medications that implicates in causing thrombocytopenia or transfer of the patient from ICU.
1 secondary outcome
The duration of hospital stay or ICU stay or The incidence of the need for renal replacement therapy (RRT) during hospital stay.
Time frame: Through study completion, an average of 1 year the occurrence of severe thrombocytopenia < 30.000 that will indicate stop receiving medications that implicates in causing thrombocytopenia or transfer of the patient from ICU.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Thrombocytopaenia and Impaired Renal Function, 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 5 inclusion and 6 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: finished, as of the sponsor's last update on 25 Jul 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The relationship between kidney function and the development of linezolidinduced thrombocytopenia (time frame: Through study completion, an average of 1 year the occurrence of severe thrombocytopenia < 30.000 that will indicate stop receiving medications that implicates in causing thrombocytopenia or transfer of the patient from ICU.). 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 25 Jul 2025.