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

Primary Purpose

Pseudomonas Aeruginosa Infection

Status
Completed
Phase
Phase 3
Locations
Spain
Study Type
Interventional
Intervention
Piperacillin-Tazobactam continuous infusion
Piperacillin-Tazobactam intermittent infusion
Sponsored by
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pseudomonas Aeruginosa Infection focused on measuring Pseudomonas, Piperacillin, Beta-lactams, Continuous infusion, Intermittent infusion, Pharmacokinetics

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital Universitario Virgen del Rocío

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Piperacillin continuous infusion

Piperacillin intermittent infusion

Arm Description

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

Piperacillin-Tazobactam 4gr intermittent infusion 4gr every 8 hours

Outcomes

Primary Outcome Measures

Proportion of patients with satisfactory clinical response (cure or improvement) at the end of Piperacillin-Tazobactam treatment
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
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
- Microbiological response: bacteriological eradication of causative organisms
Time to defervescence
- Time to the abatement of fever
Time to clinical cure
Mortality
Proportion of patients with adverse effects

Full Information

First Posted
May 16, 2011
Last Updated
September 19, 2014
Sponsor
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
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
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1. Study Identification

Unique Protocol Identification Number
NCT01577368
Brief Title
Piperacillin-Tazobactam Continuous Versus Intermittent Infusion for Pseudomonas Aeruginosa
Acronym
PiperTazo
Official Title
Efficacy and Safety of Piperacillin-Tazobactam Continuous Infusion vs Intermittent Infusion for Complicated or Nosocomial Pseudomonas Aeruginosa Infection or Suspected Infection
Study Type
Interventional

2. Study Status

Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
May 2011 (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
August 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
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

4. Oversight

Data Monitoring Committee
No

5. Study Description

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 pharmacoeconomic.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pseudomonas Aeruginosa Infection
Keywords
Pseudomonas, Piperacillin, Beta-lactams, Continuous infusion, Intermittent infusion, Pharmacokinetics

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
76 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Piperacillin continuous infusion
Arm Type
Experimental
Arm Description
Piperacillin-Tazobactam 2gr (Loading dose DAY 1) plus Piperacillin-Tazobactam continuous infusion 8gr every 24 hours
Arm Title
Piperacillin intermittent infusion
Arm Type
Active Comparator
Arm Description
Piperacillin-Tazobactam 4gr intermittent infusion 4gr every 8 hours
Intervention Type
Drug
Intervention Name(s)
Piperacillin-Tazobactam continuous infusion
Intervention Description
Piperacillin-Tazobactam 2gr (Loading dose DAY 1) plus Piperacillin-Tazobactam continuous infusion 8gr every 24 hours (DAY 1-14)
Intervention Type
Drug
Intervention Name(s)
Piperacillin-Tazobactam intermittent infusion
Intervention Description
Piperacillin-Tazobactam intermittent infusion 4gr every 8 hours (DAY 1-14)
Primary Outcome Measure Information:
Title
Proportion of patients with satisfactory clinical response (cure or improvement) at the end of Piperacillin-Tazobactam treatment
Description
Clinical cure: complete resolution of all signs and symptoms of infection Clinical improvement: resolution or improvement of most signs and symptoms of infection
Time Frame
14 days
Secondary Outcome Measure Information:
Title
Proportion of patients with clinical response (cure or improvement) at 3 days
Description
Clinical cure: complete resolution of all signs and symptoms of infection Clinical improvement: resolution or improvement of most signs and symptoms of infection
Time Frame
3 days
Title
Proportion of patients with microbiological response
Description
- Microbiological response: bacteriological eradication of causative organisms
Time Frame
3 days
Title
Time to defervescence
Description
- Time to the abatement of fever
Time Frame
14 days
Title
Time to clinical cure
Time Frame
14 days
Title
Mortality
Time Frame
28 days
Title
Proportion of patients with adverse effects
Time Frame
14 days & 60 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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 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
Facility Information:
Facility Name
Hospital Universitario Virgen del Rocío
City
Seville
ZIP/Postal Code
41013
Country
Spain

12. IPD Sharing Statement

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Piperacillin-Tazobactam Continuous Versus Intermittent Infusion for Pseudomonas Aeruginosa

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