The Effect of N-acetylcysteine in Decreasing the Incidence of Linezolid-induced Thrombocytopenia in Critically Ill Patients

• Sponsor: Helwan University (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05944458
• Collaborator: (none)
• Enrollment: 112
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 12
• Patients Per Site Per Month: 9.3

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Linezolid Induced Thrombocytopenia	Drug: N acetyl cysteine	Phase 4

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 112 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: The Effect of N-acetylcysteine in Decreasing the Incidence of Linezolid-induced Thrombocytopenia in Critically Ill Patients
• Anticipated Study Start Date: Aug 1, 2023
• Anticipated Primary Completion Date: Aug 1, 2024
• Anticipated Study Completion Date: Aug 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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: at least one day or more	Drug: N acetyl cysteine; Fluimucil 600 mg iv to be taken twice daily as infusion
Placebo Comparator: Placebo	Drug: N acetyl cysteine; Fluimucil 600 mg iv to be taken twice daily as infusion

Outcome Measures

Primary Outcome Measures

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

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

Secondary Outcome Measures

1. difference in Time to onset of LIT and time to recovery between the 2 groups [One year]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	15 May hospital	Cairo		Egypt

Sponsors and Collaborators

• Helwan University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Mohamed Abdeltawab, Clinical pharmacist, Helwan University
• ClinicalTrials.gov Identifier: NCT05944458
• Other Study ID Numbers: 11041990
• First Posted: Jul 13, 2023
• Last Update Posted: Jul 13, 2023
• Last Verified: Jul 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• 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
• Additional relevant MeSH terms: Thrombocytopenia; Acetylcysteine; N-monoacetylcystine

Study Results

No Results Posted as of Jul 13, 2023