Piperacillin-Tazobactam Continuous Versus Intermittent Infusion for Pseudomonas Aeruginosa

Pseudomonas Aeruginosa Infection Clinical Trial

— PiperTazo  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01577368
• Other study ID #: PiperTazo
• Secondary ID: 2010-024606-34
• Status: Completed
• Phase: Phase 3
• First received: May 16, 2011
• Last updated: September 19, 2014
• Start date: May 2011
• Est. completion date: August 2014

Study information

• Verified date: September 2014
• Source: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: August 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pseudomonas Aeruginosa Infection
• Pseudomonas Infections

Intervention

Drug:
• Piperacillin-Tazobactam continuous infusion
Piperacillin-Tazobactam 2gr (Loading dose DAY 1) plus Piperacillin-Tazobactam continuous infusion 8gr every 24 hours (DAY 1-14)
• Piperacillin-Tazobactam intermittent infusion
Piperacillin-Tazobactam intermittent infusion 4gr every 8 hours (DAY 1-14)

Locations

Country	Name	City	State
Spain	Hospital Universitario Virgen del Rocío	Seville

Sponsors (11)

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

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Proportion of patients with clinical response (cure or improvement) at 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	3 days	No
Secondary	Proportion of patients with microbiological response	- Microbiological response: bacteriological eradication of causative organisms	3 days	No
Secondary	Time to defervescence	- Time to the abatement of fever	14 days	No
Secondary	Time to clinical cure		14 days	No
Secondary	Mortality		28 days	No
Secondary	Proportion of patients with adverse effects		14 days & 60 days	Yes