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Completed

NCT Number: NCT01577368

Piperacillin-Tazobactam Continuous Versus Intermittent Infusion for Pseudomonas Aeruginosa

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hospital Universitario Virgen del Rocío

Seville, 41013, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Complicated or Nosocomial Pseudomonas Aeruginosa Infection or Suspected Infection
  • > 18 years and > 40 kg
  • Negative pregnancy test for women within fertile period
  • Informed consent signature

Exclusion criteria

  • Life expectancy < 72 hr
  • Central Nervous System (CNS) infection
  • Ventilator-associated pneumonia
  • Severe Neutropenia (<500 cells/ml)
  • Acinetobacter baumannii or extended spectrum beta lactamase (ESBL) suspected infection
  • Cystic fibrosis
  • Shock
  • Creatinine clearance < 20 ml/min
  • Dialysis or hemoperfusion

Treatment and study plan

Piperacillin-Tazobactam continuous infusion

Drug

Piperacillin-Tazobactam 2gr (Loading dose DAY 1) plus Piperacillin-Tazobactam continuous infusion 8gr every 24 hours (DAY 1-14)

Piperacillin-Tazobactam intermittent infusion

Drug

Piperacillin-Tazobactam intermittent infusion 4gr every 8 hours (DAY 1-14)

Primary outcomes

  1. 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

Secondary outcomes

  1. 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
  2. Proportion of patients with microbiological response

    Time frame: 3 days

    • Microbiological response: bacteriological eradication of causative organisms
  3. Time to defervescence

    Time frame: 14 days

    • Time to the abatement of fever
  4. Time to clinical cure

    Time frame: 14 days

  5. Mortality

    Time frame: 28 days

  6. Proportion of patients with adverse effects

    Time frame: 14 days & 60 days

Sponsors and collaborators

Lead sponsor

Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

Other

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

Registry information

Official study title

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

Acronym: PiperTazo

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Apr 13, 2012
Registry last updated
Sep 22, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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