Piperacillin-Tazobactam Continuous Versus Intermittent Infusion for Pseudomonas Aeruginosa (PiperTazo)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2012 by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Ministerio de Sanidad y Política social
Hospitales Universitarios Virgen del Rocío
Hospital Universitario Virgen Macarena
Hospital Son Espases
Hospital Son Llatzer
Complejo Hospitalario de Especialidades Juan Ramón Jimenez
University Hospital Virgen de las Nieves
Hospital General de Cataluña
Hospital Infanta Sofia
Hospital Universitario Ntra. Sra. de La Candelaria
Information provided by (Responsible Party):
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
ClinicalTrials.gov Identifier:
NCT01577368
First received: May 16, 2011
Last updated: April 12, 2012
Last verified: April 2012
  Purpose

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.


Condition Intervention Phase
Pseudomonas Aeruginosa Infection
Drug: Piperacillin-Tazobactam continuous infusion
Drug: Piperacillin-Tazobactam intermittent infusion
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Piperacillin-Tazobactam Continuous Infusion vs Intermittent Infusion for Complicated or Nosocomial Pseudomonas Aeruginosa Infection or Suspected Infection

Resource links provided by NLM:


Further study details as provided by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla:

Primary Outcome Measures:
  • Proportion of patients with satisfactory clinical response (cure or improvement) at the end of Piperacillin-Tazobactam treatment [ Time Frame: 14 days ] [ Designated as safety issue: No ]
    • Clinical cure: complete resolution of all signs and symptoms of infection
    • Clinical improvement: resolution or improvement of most signs and symptoms of infection


Secondary Outcome Measures:
  • Proportion of patients with clinical response (cure or improvement) at 3 days [ Time Frame: 3 days ] [ Designated as safety issue: No ]
    • 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 ] [ Designated as safety issue: No ]
    - Microbiological response: bacteriological eradication of causative organisms

  • Time to defervescence [ Time Frame: 14 days ] [ Designated as safety issue: No ]
    - Time to the abatement of fever

  • Time to clinical cure [ Time Frame: 14 days ] [ Designated as safety issue: No ]
  • Mortality [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • Proportion of patients with adverse effects [ Time Frame: 14 days & 60 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 400
Study Start Date: May 2011
Estimated Study Completion Date: October 2012
Estimated Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Piperacillin continuous infusion
Piperacillin-Tazobactam 2gr (Loading dose DAY 1) plus Piperacillin-Tazobactam continuous infusion 8gr every 24 hours
Drug: Piperacillin-Tazobactam continuous infusion
Piperacillin-Tazobactam 2gr (Loading dose DAY 1) plus Piperacillin-Tazobactam continuous infusion 8gr every 24 hours (DAY 1-14)
Active Comparator: Piperacillin intermittent infusion
Piperacillin-Tazobactam 4gr intermittent infusion 4gr every 8 hours
Drug: Piperacillin-Tazobactam intermittent infusion
Piperacillin-Tazobactam intermittent infusion 4gr every 8 hours (DAY 1-14)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  • CNS infection
  • Ventilator-associated pneumonia
  • Severe Neutropenia (<500 cells/ml)
  • Acinetobacter baummanii or ESBL suspected infection
  • Cystic fibrosis
  • Shock
  • Creatinine clearance < 20 ml/min
  • Dyalisis or hemoperfusion
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01577368

Contacts
Contact: Maria V Gil-Navarro, PhD 955013623 mariav.gil.sspa@juntadeandalucia.es
Contact: Roberto Marín-Gil, PharmD, MSc 955013622 roberto.marin.sspa@juntadeandalucia.es

Locations
Spain
Hospital Universitario Virgen del Rocío Recruiting
Seville, Spain, 41013
Principal Investigator: Maria V Gil-Navarro, PhD         
Sponsors and Collaborators
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Ministerio de Sanidad y Política social
Hospitales Universitarios Virgen del Rocío
Hospital Universitario Virgen Macarena
Hospital Son Espases
Hospital Son Llatzer
Complejo Hospitalario de Especialidades Juan Ramón Jimenez
University Hospital Virgen de las Nieves
Hospital General de Cataluña
Hospital Infanta Sofia
Hospital Universitario Ntra. Sra. de La Candelaria
  More Information

No publications provided

Responsible Party: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
ClinicalTrials.gov Identifier: NCT01577368     History of Changes
Other Study ID Numbers: PiperTazo, 2010-024606-34
Study First Received: May 16, 2011
Last Updated: April 12, 2012
Health Authority: Spain: Spanish Agency of Medicines

Keywords provided by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla:
Pseudomonas
Piperacillin
Beta-lactamics
Continuous infusion
Intermitent infusion
Pharmacokinetics

Additional relevant MeSH terms:
Pseudomonas Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Piperacillin
Penicillanic Acid
Piperacillin-tazobactam combination product
Tazobactam
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 28, 2014