Efficacy of Intravenous N-Acetylcysteine in Preventing Linezolid-Induced Thrombocytopenia in Critically Ill Patients

NCT ID: NCT05944458

Last Updated: 2025-07-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 250 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-01
• Study Completion Date: 2025-06-01

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. Blood products transfusion, bleeding, length of stay, and in-hospital mortality incidence between 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.

Conditions

Linezolid; Antioxidant; Thrombocytopenia; Critical Illness; ICU

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

N-acetylcysteine group

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: for 14 days post linezolid discontinuation or until ICU discharge, whichever came first.

Group Type: ACTIVE_COMPARATOR

N acetyl cysteine

Intervention Type: DRUG

Fluimucil 600 mg iv to be taken twice daily as infusion

Standard of care

They will receive standard of care (Platelets monitoring daily, linezolid discontinuation if platelet count less than 50000 or clinically appropriate and platelet transfusion according to the institutional protocol) plus placebo (20 ml normal saline twice daily)

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

20 ml normal saline iv every 12 hours

Interventions

N acetyl cysteine

Fluimucil 600 mg iv to be taken twice daily as infusion

Intervention Type: DRUG

Placebo

20 ml normal saline iv every 12 hours

Intervention Type: DRUG

Other Intervention Names

Fluimucil; NAC

Eligibility Criteria

Inclusion Criteria

• Adult patients (age ≥ 18 years)
• Admitted to the Intensive Care Unit (ICU)
• Candidates for intravenous linezolid therapy for ≥ 48 hours

Exclusion Criteria

• Baseline platelet count < 50 × 10⁹/L
• Diagnosis of malignancy
• Receipt of any chemotherapeutic agent within the past 6 months
• Positive COVID-19 RT-PCR test at admission
• Diagnosis of immune thrombocytopenia
• Presence of splenomegaly
• Presence of liver cirrhosis
• Presence of hepatitis C
• Refusal to provide informed consent

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Helwan University

OTHER

Sponsor Role: lead

Responsible Party

Mohamed Abdeltawab

Clinical pharmacist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mohamed Abdeltawab, Pharm D

Role: PRINCIPAL_INVESTIGATOR

Clinical pharmacy, 15 May hospital

Locations

15 May hospital

Cairo, Cairo Governorate, Egypt

Countries

Egypt

Other Identifiers

11041990

Identifier Type: -

Identifier Source: org_study_id