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| Name | Class |
|---|---|
| Fondo Nacional de Desarrollo Científico y Tecnológico, Chile | OTHER_GOV |
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The study hypothesis is that the loading dose of intravenous colistin (6 million of international units) is associated with greater clinical and microbiological efficacy, and reduced mortality of critically ill patients infected by multidrug resistant Gram- negative bacilli, compared to a scheme without loading dose.
It is a prospective, multicenter, randomized, controlled study to evaluate a scheme with and without a loading dose of 6 million international units of colistin, followed by a maintenance dose of 3 million international units every 8 hours intravenous. The study should be conducted in 3 hospitals in Chile, in critically patients presenting infection by multidrug Gram-negative bacteria and requiring be treated with colistin for at least 48 hours. The objectives of the study are: to evaluate the clinical and microbiological response, and mortality.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| loading dose of colistin | Experimental | Patients will receive a loading dose of colistin (6 million international units) followed by a maintenance dose of 3 million international units of colistin every 8 hours intravenous |
|
| without loading dose of colistin | Active Comparator | Patients will receive 3 million international units of colistin every 8 hours intravenous |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| colistin | Drug | One arm will receive a loading dose of colistin (6 million international units), and a maintenance dose of 3 million every 8 hours. The other arm will receive a maintenance dose of 3 million international units every 8 hours. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients with clinical response to treatment | remission or reduction of clinical signs of infection | up to 1 week |
| percentage of patients with microbiological response | negative culture at the same site where the positive culture was obtained before | up to 1 week |
| mortality | the mortality during their stay in the intensive care unit, an expected average of 4 weeks | during their stay in the intensive care unit |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Loreto Rojas, MD | Contact | 56-9-68479281 | rojasloreto@gmail.com | |
| Ruth Rosales, PharmD | Contact | 56-9-95093184 | ruth.rosales@vtr.net |
| Name | Affiliation | Role |
|---|---|---|
| Loreto Rojas, MD, PhD | Hospital Barros Luco Trudeau | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Barros Luco Trudeau | Recruiting | Santiago | Santiago Metropolitan | 8900085 | Chile |
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| ID | Term |
|---|---|
| D016905 | Gram-Negative Bacterial Infections |
| ID | Term |
|---|---|
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D003091 | Colistin |
| C004691 | colistinmethanesulfonic acid |
| ID | Term |
|---|---|
| D011113 | Polymyxins |
| D010456 | Peptides, Cyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
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|
| Hospital de Puerto Montt | Recruiting | Port Montt | 5507798 | Chile |
|
| 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 |