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Piperacillin-Tazobactam Continuous Versus Intermittent Infusion for Pseudomonas Aeruginosa

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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01577368
Acronym
PiperTazo
Enrollment
76
Registered
2012-04-13
Start date
2011-05-31
Completion date
2014-08-31
Last updated
2014-09-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pseudomonas Aeruginosa Infection

Keywords

Pseudomonas, Piperacillin, Beta-lactams, Continuous infusion, Intermittent infusion, Pharmacokinetics

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.

Interventions

DRUGPiperacillin-Tazobactam continuous infusion

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

DRUGPiperacillin-Tazobactam intermittent infusion

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

Sponsors

Ministerio de Sanidad y Política social
CollaboratorUNKNOWN
Hospitales Universitarios Virgen del Rocío
CollaboratorOTHER
Hospital Universitario Virgen Macarena
CollaboratorOTHER
Hospital Son Espases
CollaboratorOTHER
Hospital Son Llatzer
CollaboratorOTHER
Complejo Hospitalario de Especialidades Juan Ramón Jimenez
CollaboratorOTHER
University Hospital Virgen de las Nieves
CollaboratorOTHER
Hospital General de Cataluña
CollaboratorUNKNOWN
Hospital Infanta Sofia
CollaboratorOTHER
Hospital Universitario Ntra. Sra. de La Candelaria
CollaboratorUNKNOWN
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Proportion of patients with satisfactory clinical response (cure or improvement) at the end of Piperacillin-Tazobactam treatment14 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

MeasureTime frameDescription
Proportion of patients with microbiological response3 days\- Microbiological response: bacteriological eradication of causative organisms
Time to defervescence14 days\- Time to the abatement of fever
Proportion of patients with clinical response (cure or improvement) at 3 days3 days* Clinical cure: complete resolution of all signs and symptoms of infection * Clinical improvement: resolution or improvement of most signs and symptoms of infection
Mortality28 days
Proportion of patients with adverse effects14 days & 60 days
Time to clinical cure14 days

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026