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Objective from this study to compare the clinical outcomes and safety between colistin and tigecycline for multi-drug resistant gram negative bacteria.
Study will be in Beni-Suef university hospital. Group I: 66 patients received intravenous colistin 300 mg colistin base activity (CBA) as loading dose, followed by 2.5-5mg/kg/day of CBA in 2 divided doses as a maintenance dose in intensive care unit to treat their MDR infection and group 2 contains 66 patients received intravenous tigecycline100 mg single dose as loading dose, followed by 25-50 mg every 12 hours maintenance dose in intensive care unit to treat their MDR infection
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Colistin | Active Comparator | Intravenous colistin 300 mg colistin base activity (CBA) as loading dose, followed by 2.5-5mg/kg/day of CBA in 2 divided doses as a maintenance dose. Reconstitute each vial of CBA with 2 ml of sterile water for injection, swirl gently. further dilute in normal saline. |
|
| Tigecycline | Active Comparator | intravenous tigecycline100 mg single dose as loading dose, followed by 25-50 mg every 12 hours maintenance dose. add 5.3 ml normal saline to each 50 ml vial. swirl gently. further dilution to final concentration does not exceed 1mg/ml. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Colistimethate Sodium | Drug | compare the clinical outcomes and safety between colistin and tigecycline for multi-drug-resistant gram-negative bacteria. |
|
| Measure | Description | Time Frame |
|---|---|---|
| comparison clinical success between colistin and tigecycline | the disappearance of clinical signs and symptoms as normalization of leukocyte counts and resolution of fever after receiving colistin and tigecycline | 6 months |
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Inclusion criteria:
Study will include
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shimaa N Abd elfatah, PhD | Beni-Suef University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pharmacy | Cairo | Egypt |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 1, 2024 | Mar 11, 2025 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| C004691 | colistinmethanesulfonic acid |
| D003091 | Colistin |
| D000078304 | Tigecycline |
| ID | Term |
|---|---|
| D011113 | Polymyxins |
| D010456 | Peptides, Cyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
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Group I: 66 patients received intravenous colistin 300 mg colistin base activity (CBA) as loading dose, followed by 2.5-5mg/kg/day of CBA in 2 divided doses as a maintenance dose in intensive care unit to treat their MDR infection.
Group II: 66 patients received intravenous tigecycline100 mg single dose as loading dose, followed by 25-50 mg every 12 hours maintenance dose in intensive care unit to treat their MDR infection.
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| Tigecycline | Drug | compare the clinical outcomes and safety between colistin and tigecycline for multi-drug-resistant gram-negative bacteria. |
|
|
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| 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 |
| D013754 | Tetracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |