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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-024606-34 | EudraCT Number |
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| Name | Class |
|---|---|
| Ministerio de Sanidad y Política social | UNKNOWN |
| Hospitales Universitarios Virgen del Rocío | OTHER |
| Hospital Universitario Virgen Macarena | OTHER |
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The main objective is to verify that the administration of piperacillin / tazobactam administered by continuous infusion to treat complicated infections or with known or suspected nosocomial isolation of Pseudomonas aeruginosa is superior in efficacy to a 30% higher dose administered in conventional short infusion.
The secondary objectives were compared between the following variables:
To this end, we designed a multicenter, randomized, controlled, double blind, comparing both forms of administration in patients with complicated or nosocomial infection with or without isolation of Pseudomonas aeruginosa.
Patients who are candidates for inclusion are classified according to APACHE II and to have or not isolation of Pseudomonas aeruginosa. Subsequently be randomized to receive piperacillin-tazobactam by continuous infusion or short. Primary endpoint was measured as the ultimate effectiveness of treatment and other variables such as high efficiency, safety, pharmacokinetic and pharmacoeconomic.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Piperacillin continuous infusion | Experimental | Piperacillin-Tazobactam 2gr (Loading dose DAY 1) plus Piperacillin-Tazobactam continuous infusion 8gr every 24 hours |
|
| Piperacillin intermittent infusion | Active Comparator | Piperacillin-Tazobactam 4gr intermittent infusion 4gr every 8 hours |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Piperacillin-Tazobactam continuous infusion | Drug | Piperacillin-Tazobactam 2gr (Loading dose DAY 1) plus Piperacillin-Tazobactam continuous infusion 8gr every 24 hours (DAY 1-14) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients with satisfactory clinical response (cure or improvement) at the end of Piperacillin-Tazobactam treatment |
| 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients with clinical response (cure or improvement) at 3 days |
| 3 days |
| Proportion of patients with microbiological response |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario Virgen del Rocío | Seville | Seville | 41013 | Spain |
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| Hospital Son Espases |
| OTHER |
| Hospital Son Llatzer | OTHER |
| Complejo Hospitalario de Especialidades Juan Ramón Jimenez | OTHER |
| University Hospital Virgen de las Nieves | OTHER |
| Hospital General de Cataluña | UNKNOWN |
| Hospital Infanta Sofia | OTHER |
| Hospital Universitario Ntra. Sra. de La Candelaria | UNKNOWN |
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| Piperacillin-Tazobactam intermittent infusion | Drug | Piperacillin-Tazobactam intermittent infusion 4gr every 8 hours (DAY 1-14) |
|
- Microbiological response: bacteriological eradication of causative organisms |
| 3 days |
| Time to defervescence | - Time to the abatement of fever | 14 days |
| Time to clinical cure | 14 days |
| Mortality | 28 days |
| Proportion of patients with adverse effects | 14 days & 60 days |
| ID | Term |
|---|---|
| D011552 | Pseudomonas Infections |
| ID | Term |
|---|---|
| D016905 | Gram-Negative Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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