Investigating the risk of thrombocytopenia from linezolid in critically ill patients
The Incidence of Linezolid-induced Thrombocytopenia (LIT) in Critically Ill Patients, the Risk Factors for LIT and Time to Events (LIT, Recovery)
This study is trying to see how often critically ill patients develop low platelet counts from the antibiotic linezolid and what factors might affect this.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 310 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Helwan University Academic / other |
| Locations | 1 site (Cairo) |
| Trial ID | NCT05944445 on ClinicalTrials.gov |
What this trial studies
This observational study aims to determine the incidence of linezolid-induced thrombocytopenia (LIT) among critically ill patients, a population that has been under-researched in this context. It will evaluate various risk factors affecting the incidence, time to onset, and recovery of platelet levels. Additionally, the study will assess the influence of concurrent medications commonly used in ICU settings on the development of LIT and explore the potential preventive effects of medications with antioxidant properties. The impact of LIT on critical outcomes such as mortality, bleeding, and length of hospital stay will also be analyzed.
Who should consider this trial
Good fit: Ideal candidates for this study are adult patients aged 18 and older who are admitted to the ICU and are candidates for intravenous linezolid therapy for at least one day.
Not a fit: Patients who are taking myelosuppressive drugs, have baseline platelet counts below 50,000, have hematological malignancies, are COVID-19 patients, or have immune thrombocytopenia may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management strategies for critically ill patients receiving linezolid, potentially reducing the incidence of thrombocytopenia.
How similar studies have performed: While there is limited research specifically addressing LIT in critically ill patients, similar studies on drug-induced thrombocytopenia have shown varying degrees of success, indicating that this area is still being explored.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * All adult patients, age \> or = 18 years old, admitted to the ICU with different indications. * candidates for intravenous linezolid therapy for \> or =1 day. Exclusion Criteria: * Taking any myelosuppressive drug. * Baseline platelets \< 50000. * Patients with hematological malignancy. * COVID-19 patients. * Patients with immune thrombocytopenia
Where this trial is running
Cairo
- 15 May hospital — Cairo, Egypt (Recruiting)
Study contacts
- Study coordinator: Amina S Adly, BCPS
- Email: Aminaosamaomar@gmail.com
- Phone: 00201559030055
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.