Using acetylcysteine to reduce thrombocytopenia from linezolid in critically ill patients
The Effect of N-acetylcysteine in Decreasing the Incidence of Linezolid-induced Thrombocytopenia in Critically Ill Patients
This study is testing if giving acetylcysteine can help critically ill patients avoid low platelet counts caused by the antibiotic linezolid.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 112 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Helwan University Academic / other |
| Locations | 1 site (Cairo) |
| Trial ID | NCT05944458 on ClinicalTrials.gov |
What this trial studies
This study investigates the effect of N-acetylcysteine (NAC) on reducing the incidence of linezolid-induced thrombocytopenia (LIT) in critically ill patients. It aims to compare the incidence of LIT between patients receiving NAC and those who do not, as well as assess the time to onset of LIT and the time to recovery of platelet counts. The primary outcome is defined as a platelet count of less than 150,000 or a decrease of more than 50% from baseline. Secondary outcomes include the duration until LIT onset and recovery of platelet levels.
Who should consider this trial
Good fit: Ideal candidates are adult patients aged 18 and older who are admitted to the ICU and require intravenous linezolid therapy for at least one day.
Not a fit: Patients taking myelosuppressive drugs, those with baseline platelet counts below 50,000, or those with hematological malignancies will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the risk of thrombocytopenia in patients receiving linezolid, improving their overall treatment outcomes.
How similar studies have performed: While the specific use of NAC for LIT is novel, similar studies have explored the protective effects of NAC in other contexts, suggesting potential for success.
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. * Patients who refused to sign the informed consent
Where this trial is running
Cairo
- 15 May hospital — Cairo, Egypt (Recruiting)
Study contacts
- Principal investigator: Abdelhameed I Ebid, Phd — Faculty of pharmacy, Helwan university
- Study coordinator: Abdelhameed I Ebid, Phd
- Email: Nouran100@yahoo.co.uk
- Phone: 00201001423032
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.