Clinical Trial: Piperacillin-Tazobactam Continuous Versus Intermittent Infusion for Pseudomonas Aeruginosa

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Efficacy and Safety of Piperacillin-Tazobactam Continuous Infusion vs Intermittent Infusion for Complicated or Nosocomial Pseudomonas Aeruginosa Infection or Suspected Inf

Brief 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 pharmac

Detailed Summary:
Sponsor: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

Current Primary Outcome: Proportion of patients with satisfactory clinical response (cure or improvement) at the end of Piperacillin-Tazobactam treatment [ Time Frame: 14 days ]

  • Clinical cure: complete resolution of all signs and symptoms of infection
  • Clinical improvement: resolution or improvement of most signs and symptoms of infection


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Proportion of patients with clinical response (cure or improvement) at 3 days [ Time Frame: 3 days ]
    • Clinical cure: complete resolution of all signs and symptoms of infection
    • Clinical improvement: resolution or improvement of most signs and symptoms of infection
  • Proportion of patients with microbiological response [ Time Frame: 3 days ]
    - Microbiological response: bacteriological eradication of causative organisms
  • Time to defervescence [ Time Frame: 14 days ]
    - Time to the abatement of fever
  • Time to clinical cure [ Time Frame: 14 days ]
  • Mortality [ Time Frame: 28 days ]
  • Proportion of patients with adverse effects [ Time Frame: 14 days & 60 days ]


Original Secondary Outcome: Same as current

Information By: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

Dates:
Date Received: May 16, 2011
Date Started: May 2011
Date Completion:
Last Updated: September 19, 2014
Last Verified: September 2014