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

Helwan University

Status and phase: Completed; Phase 4

Conditions: Thrombocytopenia; Linezolid; ICU; Critical Illness; Antioxidant

Treatments: Drug: Placebo; Drug: N acetyl cysteine

Study type: Interventional

Funder types: Other

Identifiers

NCT05944458

11041990

Details and patient eligibility

About

• 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.

Full 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.

Enrollment: 250 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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250 participants in 2 patient groups, including a placebo group

N-acetylcysteine group

Active Comparator group

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: for 14 days post linezolid discontinuation or until ICU discharge, whichever came first.

Treatment:

Drug: N acetyl cysteine

Standard of care

Placebo Comparator group

Description:

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)

Treatment:

Drug: Placebo