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Colistin is a rapidly acting bactericidal antimicrobial agent that possesses a post antibiotic effect against MDRO Gram-negative bacteria, such as as Pseudomonas aeruginosa, Acinetobacterbaumannii, and Klebsiella pneumonia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High Dose Colistin | Experimental | High dose colistin protocol |
|
| Standard Dose Colistin | Active Comparator | Standard dose of colistin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High Dose Colistin | Drug | High Dose Colistin |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate safety of high dose Colistin | Evaluate the safety of high dose Colistin to treat MDRO infection in critically ill patients. The safety of high dose Colistin will be determined by number of participants whom renal function will be deviated from the baseline after administering high dose of Colistin. | 7 to 21 days after giving Colistin |
| Measure | Description | Time Frame |
|---|---|---|
| All cause mortality | 7 days after the end of therapy or at 28 days after enrollment | |
| Ventilation free days | 28 days after enrollment | |
| Length of ICU stay |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ahmed F Mady, PhD | Contact | 00966547060770 | afmady@ksmc.med.sa | |
| Basheer M Abdelrahman, pharmD | Contact | 00966563516815 |
| Name | Affiliation | Role |
|---|---|---|
| Ahmed F Mady, PhD | King Saud Medical City | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| King Saud Medical City | Recruiting | Riyadh | Riyadh Region | 00966 | Saudi Arabia |
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| ID | Term |
|---|---|
| D003141 | Communicable Diseases |
| ID | Term |
|---|---|
| D007239 | Infections |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D003091 | Colistin |
| ID | Term |
|---|---|
| D011113 | Polymyxins |
| D010456 | Peptides, Cyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
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| Standard Dose Colistin | Drug | Standard Dose Colistin |
|
|
| 28 days after enrollment |
| Microbiological response | whole body cultures will be done at day 7 of treatment and at the end of therapy | A day 7 and at the end of therapy |
| D055666 |
| Lipopeptides |
| D008055 | Lipids |
| D023181 | Antimicrobial Cationic Peptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000089882 | Antimicrobial Peptides |
| D052899 | Pore Forming Cytotoxic Proteins |
| D008565 | Membrane Proteins |
| D011506 | Proteins |