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| Name | Class |
|---|---|
| Beni-Suef University | OTHER |
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The investigator's goal in this study is to determine the clinical efficacy and safety of continuous infusion in comparison with standard intermittent infusion.
Prospective randomized controlled clinical trial on critically ill Pneumonic patients, included two groups, over one year period. The first group will be administered intravenous (IV) linezolid 600mg twice daily. The second group will be prescribed linezolid (IV) 600 mg loading dose followed by 1200 mg by continuous infusion. Both groups will be co-administered intravenous (IV) Meropenem 1g every 8 hours empirically.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Continuous infusion | Experimental | Patients will be received linezolid 600 mg intravenous Loading dose over 30 to 60 minutes followed by 1200 mg/ day by Continuous infusion (50 mg /hr) |
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| Intermittent dosing | Active Comparator | Patients will be received Linezolid 600 mg intravenous twice daily over 30 to 60 minutes |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Continuous infusion Linezolid | Drug | Linezolid 600 mg intravenous Loading dose followed by 1200 mg/ day by Continuous infusion ( 50 mg /hr ) |
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| Measure | Description | Time Frame |
|---|---|---|
| Proportion of cured patients in the linezolid continuous infusion group versus the proportion of cured patients in the intermittent group | The primary efficacy endpoint will be evaluated as clinical cure on day 7 of Linezolid initiation. Clinical cure defined by normalized body temperature, TLC less than 10,000/mL, absence of purulent secretions, and improvement of radiological findings (x-ray), in addition to Pao2/Fio2 greater than 250 in patients. | through study completion, over one year |
| Percentage of occurrence of anemia and thrombocytopenia | The patients' hematological parameters (hemoglobin (Hb), hematocrit (Hct), and platelets (PLTs) counts) will be compared every 2 days during linezolid treatment between two groups. Anemia is defined as decrease in hemoglobin level <10 g/dl and Thrombocytopenia is defined as decrese in platelets count <100 × 103/mm3 | through study completion, over one year |
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Inclusion Criteria:
Exclusion Criteria:
Adult, Older Adult
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ahmed E Abou warda, BSc | Contact | 00201007647696 | ahmed.essam@o6u.edu.eg | |
| Rania M Sarhan, PhD | Contact | 0021008789509 |
| Name | Affiliation | Role |
|---|---|---|
| Ahmed Essam, BSc | October 6 University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beni-suef University | Recruiting | Banī Suwayf | Egypt |
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| ID | Term |
|---|---|
| D011014 | Pneumonia |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D008722 | Methods |
| ID | Term |
|---|---|
| D008919 | Investigative Techniques |
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| intermittent dosing linezolid | Drug | Linezolid 600 mg intravenous twice daily |
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