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Primary outcome: difference in incidence of LIT between patients who received NAC and patients who didn't.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| N-acetylcysteine group | Active Comparator | Generic name: N-acetylcysteine.
|
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| Standard of care | Placebo Comparator | 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| N acetyl cysteine | Drug | Fluimucil 600 mg iv to be taken twice daily as infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From starting linezolid untill 14 days after linezolid discontinuation or ICU discharge whichever comes first. |
| Measure | Description | Time Frame |
|---|---|---|
| Blood products transfusion, bleeding, length of ICU stay, and in-ICU mortality incidence between 2 groups. | From start linezolid until ICU discharge | |
| Difference in time to platelet 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mohamed Abdeltawab, Pharm D | Clinical pharmacy, 15 May hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 15 May hospital | Cairo | Cairo Governorate | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41577060 | Derived | Abdeltawab M, Ebid AH, Ahmed O, Mobarez MA, Ibrahim M. N-acetylcysteine reduces incidence and duration of linezolid-associated thrombocytopenia in critically ill patients: A randomized controlled trial. Environ Toxicol Pharmacol. 2026 Mar;122:104944. doi: 10.1016/j.etap.2026.104944. Epub 2026 Jan 21. |
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| ID | Term |
|---|---|
| D013921 | Thrombocytopenia |
| D016638 | Critical Illness |
| ID | Term |
|---|---|
| D001791 | Blood Platelet Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D000095542 | Cytopenia |
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| ID | Term |
|---|---|
| D000111 | Acetylcysteine |
| ID | Term |
|---|---|
| D003545 | Cysteine |
| D000603 | Amino Acids, Sulfur |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
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| Placebo | Drug | 20 ml normal saline iv every 12 hours |
|
| 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 | From linezolid start date until date of first thrombocytopenia event, assessed up to 14 days after linezolid discontinuation or ICU discharge whichever comes first |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000596 |
| Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |