Piperacillin-Tazobactam Continuous Versus Intermittent Infusion for Pseudomonas Aeruginosa (PiperTazo)
This study is currently recruiting participants.
Verified April 2012 by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Sponsor:
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Collaborators:
Ministerio de Sanidad y Politica Social
Hospital Universitario Virgen del Rocío
Hospital Universitario Virgen Macarena
Hospital Universitario Son Espases
Hospital Universitario Son Llátzer
Hospital Juan Ramón Jiménez
Hospital Universitario Virgen de las Nieves
Hospital General de Cataluña
Hospital Infanta Sofía
Hospital Universitario Ntra. Sra. de La Candelaria
Information provided by (Responsible Party):
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
ClinicalTrials.gov Identifier:
NCT01577368
First received: May 16, 2011
Last updated: April 12, 2012
Last verified: April 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Pseudomonas Aeruginosa Infection |
Drug: Piperacillin-Tazobactam continuous infusion Drug: Piperacillin-Tazobactam intermittent infusion |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Efficacy and Safety of Piperacillin-Tazobactam Continuous Infusion vs Intermittent Infusion for Complicated or Nosocomial Pseudomonas Aeruginosa Infection or Suspected Infection |
Resource links provided by NLM:
Further study details as provided by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla:
Primary Outcome Measures:
- Proportion of patients with satisfactory clinical response (cure or improvement) at the end of Piperacillin-Tazobactam treatment [ Time Frame: 14 days ] [ Designated as safety issue: No ]
- Clinical cure: complete resolution of all signs and symptoms of infection
- Clinical improvement: resolution or improvement of most signs and symptoms of infection
Secondary Outcome Measures:
- Proportion of patients with clinical response (cure or improvement) at 3 days [ Time Frame: 3 days ] [ Designated as safety issue: No ]
- Clinical cure: complete resolution of all signs and symptoms of infection
- Clinical improvement: resolution or improvement of most signs and symptoms of infection
- Proportion of patients with microbiological response [ Time Frame: 3 days ] [ Designated as safety issue: No ]- Microbiological response: bacteriological eradication of causative organisms
- Time to defervescence [ Time Frame: 14 days ] [ Designated as safety issue: No ]- Time to the abatement of fever
- Time to clinical cure [ Time Frame: 14 days ] [ Designated as safety issue: No ]
- Mortality [ Time Frame: 28 days ] [ Designated as safety issue: No ]
- Proportion of patients with adverse effects [ Time Frame: 14 days & 60 days ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 400 |
| Study Start Date: | May 2011 |
| Estimated Study Completion Date: | October 2012 |
| Estimated Primary Completion Date: | October 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Piperacillin continuous infusion
Piperacillin-Tazobactam 2gr (Loading dose DAY 1) plus Piperacillin-Tazobactam continuous infusion 8gr every 24 hours
|
Drug: Piperacillin-Tazobactam continuous infusion
Piperacillin-Tazobactam 2gr (Loading dose DAY 1) plus Piperacillin-Tazobactam continuous infusion 8gr every 24 hours (DAY 1-14)
|
|
Active Comparator: Piperacillin intermittent infusion
Piperacillin-Tazobactam 4gr intermittent infusion 4gr every 8 hours
|
Drug: Piperacillin-Tazobactam intermittent infusion
Piperacillin-Tazobactam intermittent infusion 4gr every 8 hours (DAY 1-14)
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
- CNS infection
- Ventilator-associated pneumonia
- Severe Neutropenia (<500 cells/ml)
- Acinetobacter baummanii or ESBL suspected infection
- Cystic fibrosis
- Shock
- Creatinine clearance < 20 ml/min
- Dyalisis or hemoperfusion
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01577368
Contacts
| Contact: Maria V Gil-Navarro, PhD | 955013623 | mariav.gil.sspa@juntadeandalucia.es |
| Contact: Roberto Marín-Gil, PharmD, MSc | 955013622 | roberto.marin.sspa@juntadeandalucia.es |
Locations
| Spain | |
| Hospital Universitario Virgen del Rocío | Recruiting |
| Seville, Spain, 41013 | |
| Principal Investigator: Maria V Gil-Navarro, PhD | |
Sponsors and Collaborators
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Ministerio de Sanidad y Politica Social
Hospital Universitario Virgen del Rocío
Hospital Universitario Virgen Macarena
Hospital Universitario Son Espases
Hospital Universitario Son Llátzer
Hospital Juan Ramón Jiménez
Hospital Universitario Virgen de las Nieves
Hospital General de Cataluña
Hospital Infanta Sofía
Hospital Universitario Ntra. Sra. de La Candelaria
More Information
No publications provided
| Responsible Party: | Fundación Pública Andaluza para la gestión de la Investigación en Sevilla |
| ClinicalTrials.gov Identifier: | NCT01577368 History of Changes |
| Other Study ID Numbers: | PiperTazo, 2010-024606-34 |
| Study First Received: | May 16, 2011 |
| Last Updated: | April 12, 2012 |
| Health Authority: | Spain: Spanish Agency of Medicines |
Keywords provided by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla:
|
Pseudomonas Piperacillin Beta-lactamics |
Continuous infusion Intermitent infusion Pharmacokinetics |
Additional relevant MeSH terms:
|
Pseudomonas Infections Gram-Negative Bacterial Infections Bacterial Infections Piperacillin Penicillanic Acid Piperacillin-tazobactam combination product Tazobactam |
Anti-Bacterial Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on June 17, 2013