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Phase II clinical trial, open-labelled, prospective and single-center study directed to obtain blood samples in experimental detailed conditions in order to compare and optimize the dose of colistin in critically ill patients suffering from infections on which the indication of colistin would be accepted according to normal local protocols for severe infections treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Colistin 6 million units + 240mg/8h | Experimental | Loading dose of 6 million units of colistin+ 240mg/8h maintenance |
|
| Colistin 6 million units + 360mg/12h | Experimental | Loading dose of 6 million units of colistin+ 360mg/12h maintenance |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Colistin 6 million units + 240mg/8h | Drug | 240 mg of colistin methanesulfonate (CMS) every 8 hours, 3 million units (MU); 90 mg colistin base activity, (CBA) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic profile; Cmax (maximum reach concentration)/ MIC( Minimum inhibitory concentration) >10 | Plasma concentration will be measured for pharmacokinetic and pharmacodynamic profile the samples were drawn at 60, 120, 180, 240, 360, and 480 min after the end of the loading dose infusion and in patients of the group B, two more samples are taken at 600 and 720 min after the loading dose. Main pharmacokinetic parameters will be Cmax (maximum reach concentration)/ MIC(Minimum inhibitory concentration)>10 | Day 1 and day 3 after treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Number of drug adverse reactions | All study drug related adverse reactions will be gathered and communicated. | 21 days of follow-up |
| Pharmacodynamic profile ("Monte-Carlo simulation" (statistical methodology) with MIC (Minimum inhibitory concentration) 50 y MIC (Minimum inhibitory concentration) 90 from samples isolation) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| M. Eugenia Pachón, BD-PhD | Instituto de Biomedicina de Sevilla (IBIS) | Principal Investigator |
| José Miguel Cisneros, MD-PhD | Hospitales Universitarios Virgen del RocÃo | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario Virgen del RocÃo | Seville | Seville | 41013 | Spain |
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|
| Colistin 6 million units + 360mg/12h | Drug | 360 mg CMS every 12 hours (4.5 MU; 135 mg CBA) |
|
|
"Monte-Carlo simulation" (statistical methodology) with MIC (Minimum inhibitory concentration) 50 y MIC (Minimum inhibitory concentration) 90 from samples isolation |
| Day 1 and day 3 after treatment |
| ID | Term |
|---|---|
| D016638 | Critical Illness |
| D007239 | Infections |
| D002481 | Cellulitis |
| D011014 | Pneumonia |
| D003428 | Cross Infection |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012874 | Skin Diseases, Infectious |
| D013492 | Suppuration |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D007249 | Inflammation |
| D012141 | Respiratory Tract Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D007049 | Iatrogenic Disease |
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| ID | Term |
|---|---|
| C004691 | colistinmethanesulfonic acid |
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