Piperacillin-Tazobactam Continuous Versus Intermittent Infusion for Pseudomonas Aeruginosa
Status:
Completed
Trial end date:
2014-08-01
Target enrollment:
Participant gender:
Summary
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:
- Microbiological response at 3 days of starting treatment
- Time to microbiological cure
- Clinical response at 3 days of starting treatment
- Time to achieve defervescence
- To examine the relationship between pharmacokinetic variables and parameters of efficacy
and safety
- To test the hypothesis that continuous infusion maintains adequate plasma drug levels
compared with levels achieved with intermittent administration.
- Cost-effectiveness analysis
- Occurrence of adverse effects
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.
Phase:
Phase 3
Details
Lead Sponsor:
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Collaborators:
Complejo Hospitalario de Especialidades Juan Ramón Jimenez Hospital General de Cataluña Hospital Infanta Sofia Hospital Son Espases Hospital Son Llatzer Hospital Universitario Ntra. Sra. de La Candelaria Hospital Universitario Virgen Macarena Hospitales Universitarios Virgen del Rocío Ministerio de Sanidad y Política social University Hospital Virgen de las Nieves
Treatments:
Penicillanic Acid Piperacillin Piperacillin, Tazobactam Drug Combination Tazobactam