Clinical trial NCT01577368: Piperacillin-Tazobactam Continuous Versus Intermittent Infusion for Pseudomonas Aeruginosa
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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pseudomonas Aeruginosa Infection
Keywords: Pseudomonas
Piperacillin
Beta-lactams
Continuous infusion
Intermittent infusion
Pharmacokinetics
Lead sponsor: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Sponsor class: OTHER
Collaborators: name: Ministerio de Sanidad y Política social
name: Hospitales Universitarios Virgen del Rocío
name: Hospital Universitario Virgen Macarena
name: Hospital Son Espases
name: Hospital Son Llatzer
name: Complejo Hospitalario de Especialidades Juan Ramón Jimenez
name: University Hospital Virgen de las Nieves
name: Hospital General de Cataluña
name: Hospital Infanta Sofia
name: Hospital Universitario Ntra. Sra. de La Candelaria
First posted: 2012-04-13
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Proportion of patients with satisfactory clinical response (cure or improvement) at the end of Piperacillin-Tazobactam treatment
timeFrame: 14 days
Secondary outcomes:
measure: Proportion of patients with clinical response (cure or improvement) at 3 days
timeFrame: 3 days
measure: Proportion of patients with microbiological response
timeFrame: 3 days
measure: Time to defervescence
timeFrame: 14 days
measure: Time to clinical cure
timeFrame: 14 days
measure: Mortality
timeFrame: 28 days
measure: Proportion of patients with adverse effects
timeFrame: 14 days & 60 days
Other outcomes:
Locations:
city: Seville
country: Spain
facility: Hospital Universitario Virgen del Rocío
Study officials:
References: