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

NCT05944458 | Completed Phase 4 DMC

• 1 other identifier: 11041990
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

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.

Conditions

Linezolid; Antioxidant; Thrombocytopenia; Critical Illness; ICU

Outcome Measures

Primary Outcomes (1)

• difference in incidence of LIT between patients who received NAC and patients who didn't.

  Defined as platelets \< 150000 OR decrease \> or = 50% of baseline platelets.

  From starting linezolid untill 14 days after linezolid discontinuation or ICU discharge whichever comes first.

Secondary Outcomes (3)

• Blood products transfusion, bleeding, length of ICU stay, and in-ICU mortality incidence between 2 groups.

  From start linezolid until ICU discharge

• Difference in time to platelet recovery between the 2 groups

  From thrombocytopenia onset to recovery, assesed up to 14 days after linezolid discontinuation or ICU discharge whichever comes first

• Difference in time to thrombocytopenia onset between the 2 groups

  From linezolid start date until date of first thrombocytopenia event, assessed up to 14 days after linezolid discontinuation or ICU discharge whichever comes first

Study Arms (2)

N-acetylcysteine group

ACTIVE COMPARATOR

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.

Drug: N acetyl cysteine

Standard of care

PLACEBO COMPARATOR

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)

Drug: Placebo

Interventions

N acetyl cysteine DRUG

Fluimucil 600 mg iv to be taken twice daily as infusion

Also known as: Fluimucil, NAC

N-acetylcysteine group

Placebo DRUG

20 ml normal saline iv every 12 hours

Standard of care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Helwan University: lead

Study Sites (1)

15 May hospital

Cairo, Cairo Governorate, Egypt

Location

Related Publications (1)

• Abdeltawab M, Ebid AH, Ahmed O, Mobarez MA, Ibrahim M. N-acetylcysteine reduces incidence and duration of linezolid-associated thrombocytopenia in critically ill patients: A randomized controlled trial. Environ Toxicol Pharmacol. 2026 Jan 21;122:104944. doi: 10.1016/j.etap.2026.104944. Online ahead of print.

  PMID: 41577060 DERIVED

MeSH Terms

Conditions

Thrombocytopenia; Critical Illness

Interventions

Acetylcysteine

Condition Hierarchy (Ancestors)

Blood Platelet Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Cytopenia; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cysteine; Amino Acids, Sulfur; Sulfur Compounds; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Mohamed Abdeltawab, Pharm D

  Clinical pharmacy, 15 May hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical pharmacist

Study Record Dates

• First Submitted: July 6, 2023
• First Posted: July 13, 2023
• Study Start: August 1, 2023
• Primary Completion: June 1, 2025
• Study Completion: June 1, 2025
• Last Updated: July 14, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)