Pseudomonas Aeruginosa InfectionPhase 3PiperTazoNCT01577368
Piperacillin-Tazobactam Continuous Versus Intermittent Infusion for Pseudomonas Aeruginosa
A Phase 3 study testing Piperacillin-Tazobactam continuous infusion and Piperacillin-Tazobactam intermittent infusion in people with Pseudomonas Aeruginosa Infection, run by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pseudomonas Aeruginosa Infection
- What is being tested?
- Piperacillin-Tazobactam continuous infusion and Piperacillin-Tazobactam intermittent infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteSpain
- Study dates
- May 2011to Aug 2014
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Shock
- Creatinine clearance < 20 ml/min
- Dialysis or hemoperfusion
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Safety of Piperacillin-Tazobactam Continuous Infusion vs Intermittent Infusion for Complicated or Nosocomial Pseudomonas Aeruginosa Infection or Suspected Infection
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:
Read more
- 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.
- Conditions
- Pseudomonas Aeruginosa Infection
- Being tested
- Piperacillin-Tazobactam continuous infusion, Piperacillin-Tazobactam intermittent infusion
- Keywords
- Pseudomonas, Piperacillin, Beta-lactams, Continuous infusion, Intermittent infusion, Pharmacokinetics
- Medical subject headings
- Pseudomonas Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Piperacillin-Tazobactam continuous infusionDrug
Piperacillin-Tazobactam 2gr (Loading dose DAY 1) plus Piperacillin-Tazobactam continuous infusion 8gr every 24 hours (DAY 1-14)
Piperacillin-Tazobactam intermittent infusionDrug
Piperacillin-Tazobactam intermittent infusion 4gr every 8 hours (DAY 1-14)
| Study group | Role | What they receive |
|---|---|---|
| Piperacillin continuous infusion | Experimental | Piperacillin-Tazobactam 2gr (Loading dose DAY 1) plus Piperacillin-Tazobactam continuous infusion 8gr every 24 hours Receives: Drug: Piperacillin-Tazobactam continuous infusion |
| Piperacillin intermittent infusion | Active comparator | Piperacillin-Tazobactam 4gr intermittent infusion 4gr every 8 hours Receives: Drug: Piperacillin-Tazobactam intermittent infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 14 days
Secondary outcomes (6)
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
Measured: 3 days
Proportion of patients with microbiological response
- Microbiological response: bacteriological eradication of causative organisms
Measured: 3 days
Time to defervescence
- Time to the abatement of fever
Measured: 14 days
Time to clinical cure
Measured: 14 days
Mortality
Measured: 28 days
Proportion of patients with adverse effects
Measured: 14 days & 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2012 (estimated)
- Study startMay 2011
- Primary completionJan 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pseudomonas Aeruginosa InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
- Sponsor type
- University, hospital or other
- Collaborators
- Ministerio de Sanidad y Política social, Hospitales Universitarios Virgen del Rocío, Hospital Universitario Virgen Macarena, Hospital Son Espases, Hospital Son Llatzer, Complejo Hospitalario de Especialidades Juan Ramón Jimenez, University Hospital Virgen de las Nieves, Hospital General de Cataluña, Hospital Infanta Sofia, Hospital Universitario Ntra. Sra. de La Candelaria
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01577368
- Sponsor's protocol ID
- PiperTazo
- Other IDs
- 2010-024606-34
- Acronym
- PiperTazo
- Status last verified
- Sep 2014
- First submitted
- 16 May 2011
- Last updated
- 22 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Piperacillin-Tazobactam Continuous Infusion vs Intermittent Infusion for Complicated or Nosocomial Pseudomonas Aeruginosa Infection or Suspected Infection
- ClinicalTrials.gov ID
- NCT01577368
- Acronym / sponsor ID
- PiperTazo / PiperTazo
- Conditions
- Pseudomonas Aeruginosa Infection
- Keywords
- Pseudomonas, Piperacillin, Beta-lactams, Continuous infusion, Intermittent infusion, Pharmacokinetics
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Fundación Pública Andaluza para la gestión de la Investigación en SevillaUniversity, hospital or other
- Collaborators
- Ministerio de Sanidad y Política social, Hospitales Universitarios Virgen del Rocío, Hospital Universitario Virgen Macarena, Hospital Son Espases, Hospital Son Llatzer, Complejo Hospitalario de Especialidades Juan Ramón Jimenez, University Hospital Virgen de las Nieves, Hospital General de Cataluña, Hospital Infanta Sofia, Hospital Universitario Ntra. Sra. de La Candelaria
- Study start
- May 2011
- Primary completion
- Jan 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 13 Apr 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Piperacillin continuous infusion | Experimental | Drug: Piperacillin-Tazobactam continuous infusionPiperacillin-Tazobactam 2gr (Loading dose DAY 1) plus Piperacillin-Tazobactam continuous infusion 8gr every 24 hours |
| Piperacillin intermittent infusion | Active comparator | Drug: Piperacillin-Tazobactam intermittent infusionPiperacillin-Tazobactam 4gr intermittent infusion 4gr every 8 hours |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Piperacillin-Tazobactam continuous infusionPiperacillin-Tazobactam 2gr (Loading dose DAY 1) plus Piperacillin-Tazobactam continuous infusion 8gr every 24 hours (DAY 1-14) | Drug | Piperacillin continuous infusion |
| Piperacillin-Tazobactam intermittent infusionPiperacillin-Tazobactam intermittent infusion 4gr every 8 hours (DAY 1-14) | Drug | Piperacillin intermittent infusion |
Primary outcome
Proportion of patients with satisfactory clinical response (cure or improvement) at the end of Piperacillin-Tazobactam treatment
Time frame: 14 days
* Clinical cure: complete resolution of all signs and symptoms of infection * Clinical improvement: resolution or improvement of most signs and symptoms of infection
6 secondary outcomes
Proportion of patients with clinical response (cure or improvement) at 3 days
Time frame: 3 days
Proportion of patients with microbiological response
Time frame: 3 days
Time to defervescence
Time frame: 14 days
Time to clinical cure
Time frame: 14 days
Mortality
Time frame: 28 days
Proportion of patients with adverse effects
Time frame: 14 days & 60 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Piperacillin-Tazobactam continuous infusion and Piperacillin-Tazobactam intermittent infusion in people with Pseudomonas Aeruginosa Infection, run by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients with satisfactory clinical response (cure or improvement) at the end of Piperacillin-Tazobactam treatment (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2014.