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

July 8, 2025 updated by: Mohamed Abdeltawab, Helwan University

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

  • 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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
250

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Egypt
      • Cairo, Egypt
        • 15 May hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: 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.
Drug: N acetyl cysteine
Fluimucil 600 mg iv to be taken twice daily as infusion
Other Names:
  • NAC
  • Fluimucil
Placebo Comparator: 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)
Drug: Placebo
20 ml normal saline iv every 12 hours

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
From starting linezolid untill 14 days after linezolid discontinuation or ICU discharge whichever comes first.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Blood products transfusion, bleeding, length of ICU stay, and in-ICU mortality incidence between 2 groups.
Time Frame: From start linezolid until ICU discharge
From start linezolid until ICU discharge
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
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
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
From linezolid start date until date of first thrombocytopenia event, assessed up to 14 days after linezolid discontinuation or ICU discharge whichever comes first

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Helwan University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Mohamed Abdeltawab, Pharm D, Clinical pharmacy, 15 May hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 6, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 6, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 13, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 14, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 8, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 11041990

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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