Back to resultsThe Effect of N-acetylcysteine in Decreasing the Incidence of Linezolid-induced Thrombocytopenia in Critically Ill Patients
Primary Purpose
Linezolid Induced Thrombocytopenia
Status
Not yet recruiting
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
N acetyl cysteine
Sponsored by
About this trial
This is an interventional prevention trial for Linezolid Induced Thrombocytopenia
Eligibility Criteria
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
Sites / Locations
- 15 May hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Acetylcysteine group
Placebo
Arm Description
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
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
difference in Time to onset of LIT and time to recovery between the 2 groups
after having thrombocytopenia, regardless of discontinuation of linezolid, recovery is defined as the restoration and maintenance of platelet counts > 70% of baseline values
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05944458
Brief Title
The Effect of N-acetylcysteine in Decreasing the Incidence of Linezolid-induced Thrombocytopenia in Critically Ill Patients
Official Title
The Effect of N-acetylcysteine in Decreasing the Incidence of Linezolid-induced Thrombocytopenia in Critically Ill Patients
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 2023 (Anticipated)
Primary Completion Date
August 2024 (Anticipated)
Study Completion Date
August 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Helwan University
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Linezolid Induced Thrombocytopenia
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
112 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Acetylcysteine group
Arm Type
Active Comparator
Arm Description
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
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
N acetyl cysteine
Intervention Description
Fluimucil 600 mg iv to be taken twice daily as infusion
Primary Outcome Measure Information:
Title
difference in incidence of LIT between patients who received NAC and patients who didn't.
Description
Defined as platelets < 150000 OR decrease > or = 50% of baseline platelets.
Time Frame
One year
Secondary Outcome Measure Information:
Title
difference in Time to onset of LIT and time to recovery between the 2 groups
Description
after having thrombocytopenia, regardless of discontinuation of linezolid, recovery is defined as the restoration and maintenance of platelet counts > 70% of baseline values
Time Frame
One year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
15 May hospital
City
Cairo
Country
Egypt
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marwa Soliman
Phone
00201016994685
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
The Effect of N-acetylcysteine in Decreasing the Incidence of Linezolid-induced Thrombocytopenia in Critically Ill Patients
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