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

Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

Status and phase: Completed; Phase 3

Conditions: Pseudomonas Aeruginosa Infection

Treatments: Drug: Piperacillin-Tazobactam continuous infusion; Drug: Piperacillin-Tazobactam intermittent infusion

Study type: Interventional

Funder types: Other

Identifiers

NCT01577368

2010-024606-34 (EudraCT Number)

PiperTazo

Details and patient eligibility

About

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.

Enrollment: 76 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

76 participants in 2 patient groups

Piperacillin continuous infusion

Experimental group

Description:

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

Treatment:

Drug: Piperacillin-Tazobactam continuous infusion

Piperacillin intermittent infusion

Active Comparator group

Description:

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

Treatment:

Drug: Piperacillin-Tazobactam intermittent infusion