The Effect of NAC in Decreasing the Incidence of Linezolid-induced Thrombocytopenia in Critically Ill Patients

Phase 4

Recruiting

• Conditions: Linezolid Induced Thrombocytopenia
• Interventions: Drug: N acetyl cysteine

• Registration Number: NCT05944458
• Lead Sponsor: Helwan University

Brief Summary

* Study the effect of acetylcysteine on decreasing the incidence of LIT in critically ill patients.

* Study the impact of acetylcysteine on the time to onset of LIT and the time to recovery of platelets.

Detailed Description

Primary outcome: difference in incidence of LIT between patients who received NAC and patients who didn't.

* Primary outcome definition: Defined as platelets \< 150000 OR decrease \> 50% of baseline platelets.

* Secondary outcome: difference in Time to onset of LIT and time to recovery between the 2 groups.

* Secondary outcome definitions: after having thrombocytopenia, regardless of discontinuation of linezolid, recovery is defined as the restoration and maintenance of platelet counts \> 70% of baseline values.

Study Timeline

• Study First Submitted: 2023-07-06
• Study First Submitted QC: 2023-07-06
• Study First Posted: 2023-07-13
• Study Start: 2023-08-01
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-12
• Last Update Posted: 2024-01-17
• Primary Completion: 2024-08
• Study Completion: 2024-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 112

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	N acetyl cysteine	They will receive placebo drug.
Acetylcysteine group	N acetyl cysteine	Generic name: N-acetylcysteine. * Trade name: Fluimucil. * Company: Zambon. * Dosage form: ampoules for intravenous administration. * Dose: 600mg taken every 12 hours daily with a fixed dose as there is no need for renal or hepatic adjustment, starting with the inception of linezolid therapy. * Duration: at least one day or more

Primary Outcome Measures

Name	Time	Method
difference in incidence of LIT between patients who received NAC and patients who didn't.	One year	Defined as platelets \< 150000 OR decrease \> or = 50% of baseline platelets.

Secondary Outcome Measures

Name	Time	Method
difference in Time to onset of LIT and time to recovery between the 2 groups	One year	after having thrombocytopenia, regardless of discontinuation of linezolid, recovery is defined as the restoration and maintenance of platelet counts \> 70% of baseline values

Trial Locations

Locations (1)

15 May hospital; 🇪🇬 Cairo, Egypt