PiperTazo: Piperacillin-Tazobactam Continuous Versus Intermittent Infusion for Pseudomonas Aeruginosa

Sponsor

Fundación Pública Andaluza para la gestión de la Investigación en Sevilla (Other)

Overall Status

Completed

CT.gov ID

NCT01577368

Collaborator

Ministerio de Sanidad y Política social (Other), Hospitales Universitarios Virgen del Rocío (Other), Hospital Universitario Virgen Macarena (Other), Hospital Son Espases (Other), Hospital Son Llatzer (Other), Complejo Hospitalario de Especialidades Juan Ramón Jimenez (Other), University Hospital Virgen de las Nieves (Other), Hospital General de Cataluña (Other), Hospital Infanta Sofia (Other), Hospital Universitario Ntra. Sra. de La Candelaria (Other)

Enrollment

Location

Arms

Duration (Months)

1.9

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Pseudomonas Aeruginosa Infection	Drug: Piperacillin-Tazobactam continuous infusion Drug: Piperacillin-Tazobactam intermittent infusion	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

76 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, 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

Study Start Date :

May 1, 2011

Actual Primary Completion Date :

Jan 1, 2014

Actual Study Completion Date :

Aug 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
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)

Arm

Intervention/Treatment

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)

Outcome Measures

Primary Outcome Measures

Proportion of patients with satisfactory clinical response (cure or improvement) at the end of Piperacillin-Tazobactam treatment [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 Outcome Measures

Proportion of patients with clinical response (cure or improvement) at 3 days [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 [3 days]
- Microbiological response: bacteriological eradication of causative organisms
Time to defervescence [14 days]
- Time to the abatement of fever
Time to clinical cure [14 days]
Mortality [28 days]
Proportion of patients with adverse effects [14 days & 60 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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