Infectious DiseasePhase 4NCT01198925
Assessment of the Optimal Dosing of Piperacillin-tazobactam in Intensive Care Unit Patients: Extended Versus Continuous Infusion
A Phase 4 study testing piperacillin continuous infusion and piperacillin extended infusion in people with Infectious Disease, run by University Hospital, Ghent at 1 site in Belgium.
Trial summary
Piperacillin-tazobactam is an acylureido-penicillin-beta-lactamase inhibitor combination and is frequently used in the empirical treatment of hospital-acquired infections because of its antipseudomonal activity. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Infectious Disease
- What is being tested?
- piperacillin continuous infusion and piperacillin extended infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteBelgium
- Study dates
- 23 Sep 2010to 3 May 2018
- Phase
- Phase 4
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients (> 18 years) admitted on the intensive care unit (surgical and medical surgery).
- Starting a treatment with piperacillin/tazobactam
- Signed informed consent
- Hematocrit >= 21%
- Available arterial line
Who cannot join
- age <18 or >75 years
- patient's weight <50 or >100 kg
- renal insufficiency (estimated clearance < 50 ML /MIN)
- haemodialysis
- WBC < 1000 103 µl
- estimated survival <5 days
Show all 12Show fewer
- meningitis or other proven infections of the CNS
- IgE-mediated allergy to penicillins
- pregnancy
- patients having participated in another study <30 days before inclusion in the present study
- retrospectively, marked deterioration of the renal function during the study period
- retrospectively, treatment < 96 h
Trial locations and contacts
1 site in 1 country.
About this study
Piperacillin-tazobactam is an acylureido-penicillin-beta-lactamase inhibitor combination and is frequently used in the empirical treatment of hospital-acquired infections because of its antipseudomonal activity. Similar to other beta-lactam antibiotics, piperacillin-tazobactam exhibits time-dependent killing and the T > MIC appears to be the best outcome predictor. Because a majority of infections are treated empirically, it is necessary to achieve a T > MIC equal to 50% of the dosing interval (50% T > MIC) against the most likely pathogens, including those with only moderate susceptibility The aim of this study is to compare the same dose of piperacillin/tazobactam administered by an extended infusion versus a continuous infusion. A pharmacokinetic study will be performed in patients treated by extended (loading dose 4 G/30 min followed by 4 X 4 G /3h) and continuous infusion (loading dose 4 G/30 min followed by 16G /24h).
A population pharmacokinetic analysis with Monte Carlo simulations will be used to determine 95% probability of target attainment (PTA95) versus MIC
- Conditions
- Infectious Disease
- Being tested
- piperacillin continuous infusion, piperacillin extended infusion
- Keywords
- Infectious disease, piperacillin, continuous infusion, extended infusion
- Medical subject headings
- Communicable Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
piperacillin continuous infusionDrug
piperacillin continuous infusion
piperacillin extended infusionDrug
piperacillin extended infusion
| Study group | Role | What they receive |
|---|---|---|
| extended infusion | Active comparator | Not described Receives: Drug: piperacillin extended infusion |
| continuous infusion | Experimental | Not described Receives: Drug: piperacillin continuous infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
pharmacokinetics of piperacillin continuous infusion compared to piperacillin extended infusion
Determination of serum concentrations of piperacillin.
Measured: 6 hours
Secondary outcomes (1)
95% probability of target attainment (PTA95) versus MIC of different organisms.
Determination of the probability of target attainment versus MIC of different organisms.
Measured: 96 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2010 (estimated)
- Study start23 Sep 2010
- Primary completion16 Nov 2012
- Study completion3 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infectious DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Johan Decruyenaere, MD, PhD, Principal investigator, University Hospital Ghent, Belgium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01198925
- Sponsor's protocol ID
- 2010/414
- Status last verified
- May 2018
- First submitted
- 8 Sep 2010
- Last updated
- 11 May 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Optimal Dosing of Piperacillin-tazobactam in Intensive Care Unit Patients: Extended Versus Continuous Infusion
- ClinicalTrials.gov ID
- NCT01198925
- Acronym / sponsor ID
- 2010/414
- Conditions
- Infectious Disease
- Keywords
- Infectious disease, piperacillin, continuous infusion, extended infusion
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- 23 Sep 2010 (actual)
- Primary completion
- 16 Nov 2012 (actual)
- Study completion
- 3 May 2018 (actual)
- First posted
- 10 Sep 2010 (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.
Piperacillin-tazobactam is an acylureido-penicillin-beta-lactamase inhibitor combination and is frequently used in the empirical treatment of hospital-acquired infections because of its antipseudomonal activity. Similar to other beta-lactam antibiotics, piperacillin-tazobactam exhibits time-dependent killing and the T > MIC appears to be the best outcome predictor. Because a majority of infections are treated empirically, it is necessary to achieve a T > MIC equal to 50% of the dosing interval (50% T > MIC) against the most likely pathogens, including those with only moderate susceptibility The aim of this study is to compare the same dose of piperacillin/tazobactam administered by an extended infusion versus a continuous infusion. A pharmacokinetic study will be performed in patients treated by extended (loading dose 4 G/30 min followed by 4 X 4 G /3h) and continuous infusion (loading dose 4 G/30 min followed by 16G /24h).
A population pharmacokinetic analysis with Monte Carlo simulations will be used to determine 95% probability of target attainment (PTA95) versus MIC
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| extended infusion | Active comparator | Drug: piperacillin extended infusion |
| continuous infusion | Experimental | Drug: piperacillin continuous infusion |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult patients (> 18 years) admitted on the intensive care unit (surgical and medical surgery).
- Starting a treatment with piperacillin/tazobactam
- Signed informed consent
- Hematocrit >= 21%
- Available arterial line
Key exclusion criteria (12 listed)
- age <18 or >75 years
- patient's weight <50 or >100 kg
- renal insufficiency (estimated clearance < 50 ML /MIN)
- haemodialysis
- WBC < 1000 103 µl
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 continuous infusionpiperacillin continuous infusion | Drug | continuous infusion |
| piperacillin extended infusionpiperacillin extended infusion | Drug | extended infusion |
Primary outcome
pharmacokinetics of piperacillin continuous infusion compared to piperacillin extended infusion
Time frame: 6 hours
Determination of serum concentrations of piperacillin.
1 secondary outcome
95% probability of target attainment (PTA95) versus MIC of different organisms.
Time frame: 96 hours
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 11 May 2018.
- website University Hospital Ghent, BelgiumLink provided by the sponsor.
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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.
Johan Decruyenaere, MD, PhD principal investigator
University Hospital Ghent, Belgium
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing piperacillin continuous infusion and piperacillin extended infusion in people with Infectious Disease, run by University Hospital, Ghent at 1 site in Belgium.
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 5 inclusion and 12 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 11 May 2018. 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 Belgium. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
pharmacokinetics of piperacillin continuous infusion compared to piperacillin extended infusion (time frame: 6 hours). 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 11 May 2018.