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Completed

NCT Number: NCT05944458

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

* 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.

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Key information

Conditions

Linezolid Antioxidant Blood Platelet Disorders Critical Illness Cytopenia Disease Attributes Hematologic Diseases Hemic and Lymphatic Diseases ICU Pathologic Processes Pathological Conditions, Signs and Symptoms Thrombocytopenia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

15 May hospital

Cairo, Cairo Governorate, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

n acetyl cysteine

Drug

Fluimucil 600 mg iv to be taken twice daily as infusion

Other names: Fluimucil, NAC

Placebo

Drug

20 ml normal saline iv every 12 hours

Primary outcomes

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

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

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

Secondary outcomes

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

    Time frame: From start linezolid until ICU discharge

  2. Difference in time to platelet recovery between the 2 groups

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

    after having thrombocytopenia, regardless of discontinuation of linezolid, recovery is defined as the restoration and maintenance of platelet counts > 70% of baseline values

  3. Difference in time to thrombocytopenia onset between the 2 groups

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

Sponsors and collaborators

Lead sponsor

Helwan University

Other

Registry information

Official study title

Efficacy of Intravenous N-Acetylcysteine in Preventing Linezolid-Induced Thrombocytopenia in Critically Ill Patients: A Double-Blind Randomized Placebo-Controlled Trial

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jul 13, 2023
Registry last updated
Jul 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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