NCT01577368

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
76

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started May 2011

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2011

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

May 16, 2011

Completed
11 months until next milestone

First Posted

Study publicly available on registry

April 13, 2012

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
Last Updated

September 22, 2014

Status Verified

September 1, 2014

Enrollment Period

2.7 years

First QC Date

May 16, 2011

Last Update Submit

September 19, 2014

Conditions

Pseudomonas Aeruginosa Infection

Keywords

PseudomonasPiperacillinBeta-lactamsContinuous infusionIntermittent infusionPharmacokinetics

Outcome Measures

Primary Outcomes (1)

  • 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

    14 days

Secondary Outcomes (6)

  • Proportion of patients with clinical response (cure or improvement) at 3 days

    3 days

  • Proportion of patients with microbiological response

    3 days

  • Time to defervescence

    14 days

  • Time to clinical cure

    14 days

  • Mortality

    28 days

  • +1 more secondary outcomes

Study Arms (2)

Piperacillin continuous infusion

EXPERIMENTAL

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

Drug: Piperacillin-Tazobactam continuous infusion

Piperacillin intermittent infusion

ACTIVE COMPARATOR

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

Drug: Piperacillin-Tazobactam intermittent infusion

Interventions

Piperacillin-Tazobactam continuous infusionDRUG

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

Piperacillin continuous infusion
Piperacillin-Tazobactam intermittent infusionDRUG

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

Piperacillin intermittent infusion

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitario Virgen del Rocío

Seville, Seville, 41013, Spain

Location

MeSH Terms

Conditions

Pseudomonas Infections

Condition Hierarchy (Ancestors)

Gram-Negative Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 16, 2011

First Posted

April 13, 2012

Study Start

May 1, 2011

Primary Completion

January 1, 2014

Study Completion

August 1, 2014

Last Updated

September 22, 2014

Record last verified: 2014-09

Locations

ES(1)