Compare Linezolid-Induced Thrombocytopenia in Patients With Normal Renal Function Versus Impaired Renal Function

NCT06761131 | Completed

• 1 other identifier: FMASU MD35/2024
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Linezolid exhibits a broad spectrum of activity against Gram-positive bacteria, including methicillin-resistant staphylococcus aureus (MRSA) and vancomycin-resistant enterococci. The major adverse effect associated with linezolid treatment is reversible myelosuppression, mostly thrombocytopenia. Recent studies have reported that the incidence of linezolid-induced thrombocytopenia was higher among patients with renal failure than in patients with normal renal function, although the underlying mechanisms explaining this toxicity are still unknown.

Conditions

Thrombocytopaenia; Impaired Renal Function

Outcome Measures

Primary Outcomes (1)

• The relationship between kidney function and the development of linezolidinduced thrombocytopenia

  Through study completion, an average of 1 year the occurrence of severe thrombocytopenia < 30.000 that will indicate stop receiving medications that implicates in causing thrombocytopenia or transfer of the patient from ICU.

Secondary Outcomes (1)

• The duration of hospital stay or ICU stay or The incidence of the need for renal replacement therapy (RRT) during hospital stay.

  Through study completion, an average of 1 year the occurrence of severe thrombocytopenia < 30.000 that will indicate stop receiving medications that implicates in causing thrombocytopenia or transfer of the patient from ICU.

Study Arms (2)

Group N (will be with normal renal function)

Drug: Linezolid (LZD)

Group I (will be with impaired renal function)

Drug: Linezolid (LZD)

Interventions

Linezolid (LZD) DRUG

compare the incidence and magnitude of Linezolid induced thrombocytopenia

Group I (will be with impaired renal function); Group N (will be with normal renal function)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

After obtaining approval from the research ethical committee of the Anesthesia, Intensive care and Pain management department, Ain Shams University; this study will be conducted in the ICUs of Ain Shams University Hospitals.

You may qualify if:

• Patients diagnosed with sepsis having 2 or more of the following criteria:
• Septic shock clinically identified by a vasopressor requirement to maintain a mean arterial blood pressure of 65 mm Hg or greater.
• Serum lactate level greater than 2 mmol\\L.
• Positive culture confirming bacterial infection.
• Patients highly susceptible to infection by Gram-positive bacteria such as Nosocomial pneumonia, Community-acquired pneumonia, Complicated skin and soft tissue infections.

You may not qualify if:

• Patient or their legal guardian refuses to include their data in the study.
• Known allergy to linezolid.
• Pregnancy and lactation.
• Severe hepatic failure (Child-Pugh C as INR\>2.3, Bilirubin\>3mg/dl, Albumin\<2.8gm/dl).
• Thrombocytopenia (platelet count \< 80,000/mm3).
• Disseminated intravascular coagulation (DIC) as Fibrinogen\<1g/L, PT more than 6 seconds increase above normal, high D Dimer level.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University Hospitals

Cairo, Egypt

Location

MeSH Terms

Conditions

Thrombocytopenia; Renal Insufficiency

Interventions

Linezolid

Condition Hierarchy (Ancestors)

Blood Platelet Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Cytopenia; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Acetamides; Amides; Organic Chemicals; Acetates; Acids, Acyclic; Carboxylic Acids; Oxazolidinones; Oxazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Week
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 26, 2024
• First Posted: January 7, 2025
• Study Start: May 20, 2024
• Primary Completion: May 20, 2025
• Study Completion: June 20, 2025
• Last Updated: July 25, 2025

Record last verified: 2025-07

Locations

EG (1)