Diffusive and Convective ClearancePhase 4PTCRRTNCT00703144
Pharmacokinetics of Piperacillin/Tazobactam in Patients Treated by Continuous Renal Replacement Therapy
A Phase 4 study testing piperacillin/tazobactam and Pharmacokinetic in people with Diffusive and Convective Clearance and Body Clearance, run by University Hospital, Toulouse at 1 site in France.
Trial summary
The pharmacokinetics of piperacillin/tazobactam will be evaluated in twenty septic patients with renal failure undergoing continuous veno-venous hemodiafiltration. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diffusive and Convective Clearance, Body Clearance, Piperacillin Tazocilline Concentrations (Cmin)
- What is being tested?
- piperacillin/tazobactam and Pharmacokinetic
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2008to Aug 2012
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age and older .
- Females of childbearing potential must have a negative pregnancy test at screening.
- Subjects whose life expectancy is estimated over 7 days.
- Anuric patients requiring continuous venovenous hemodiafiltration
- Septic patients,severe sepsis or septic shock
- Written informed consent should be given either by the patient or a member of his family
Who cannot join
- Subjects with a history of true allergy or adverse drug reactions
- Pathogens whose antibiotic susceptibility is not proved.
- Patients having impaired hepatic function
- Contraindication of anticoagulation by heparin
- Residual renal function
- Participation in a clinical trial
- Interruption of treatment by piper/tazo or hemodiafiltration during the study.
- Patients with psychiatric disorder or serious medical condition which in the opinion of the investigator may lead to complexity in patient management.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pharmacokinetics of Piperacillin and Tazobactam in Anuric Septic Patients Treated by Continuous Veno Venous Hemodiafiltration
The pharmacokinetics of piperacillin/tazobactam will be evaluated in twenty septic patients with renal failure undergoing continuous veno-venous hemodiafiltration.
Read the detailed description
The pharmacokinetics of piperacillin/tazobactam will be evaluated in twenty septic patients with renal failure undergoing continuous veno-venous hemodiafiltration. This is a prospective study.
Continuous replacement therapy has a continuous effect on drug elimination which could compromise effective antibiotic treatment.
Patients will receive a standard course of pip/tazo 4g intravenously 8 hourly administrated immediately when CVVHDF will be started.
Blood samples will be collected at 30mn, 2h, 4h, 6h, 8h, 16h, 24h for the first and the second day.
We will measure plasma piperacillin/tazobactam concentration and compare them to MICs for the whole dosing interval.
- Conditions
- Diffusive and Convective Clearance, Body Clearance, Piperacillin Tazocilline Concentrations (Cmin)
- Being tested
- piperacillin/tazobactam, Pharmacokinetic
- Keywords
- Pharmacokinetics, piperacillin/tazobactam., Septic patients, oliguric renal failure, continuous veno-venous hemodiafiltration.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
piperacillin/tazobactamDrug
Also called Tazocilline
piperacillin 4 g and tazobactam 500 mg during 30 min IV infusion every 8h during 2 consecutive days
PharmacokineticProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Pharmacokinetic | Experimental | Not described Receives: Drug: piperacillin/tazobactam; Procedure: Pharmacokinetic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum levels of both piperacillin and tazobactam (Cmin) during 2 daus
Measured: 2 days
Secondary outcomes (1)
Body clearance
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2008 (estimated)
- Study startJun 2008
- Primary completionAug 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diffusive and Convective ClearanceStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- LAVAYSSIERE Laurence, MD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00703144
- Sponsor's protocol ID
- 07 300 02
- Other IDs
- University Hospital Toulouse
- Acronym
- PTCRRT
- Status last verified
- Jan 2013
- First submitted
- 20 Jun 2008
- Last updated
- 24 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics of Piperacillin and Tazobactam in Anuric Septic Patients Treated by Continuous Veno Venous Hemodiafiltration
- ClinicalTrials.gov ID
- NCT00703144
- Acronym / sponsor ID
- PTCRRT / 07 300 02
- Conditions
- Diffusive and Convective Clearance, Body Clearance, Piperacillin Tazocilline Concentrations (Cmin)
- Keywords
- Pharmacokinetics, piperacillin/tazobactam., Septic patients, oliguric renal failure, continuous veno-venous hemodiafiltration.
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- Jun 2008
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 23 Jun 2008 (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 pharmacokinetics of piperacillin/tazobactam will be evaluated in twenty septic patients with renal failure undergoing continuous veno-venous hemodiafiltration.
Detailed description
The pharmacokinetics of piperacillin/tazobactam will be evaluated in twenty septic patients with renal failure undergoing continuous veno-venous hemodiafiltration. This is a prospective study.
Continuous replacement therapy has a continuous effect on drug elimination which could compromise effective antibiotic treatment.
Patients will receive a standard course of pip/tazo 4g intravenously 8 hourly administrated immediately when CVVHDF will be started.
Blood samples will be collected at 30mn, 2h, 4h, 6h, 8h, 16h, 24h for the first and the second day.
We will measure plasma piperacillin/tazobactam concentration and compare them to MICs for the whole dosing interval.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pharmacokinetic | Experimental | Drug: piperacillin/tazobactam, Procedure: Pharmacokinetic |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 18 years of age and older .
- Females of childbearing potential must have a negative pregnancy test at screening.
- Subjects whose life expectancy is estimated over 7 days.
- Anuric patients requiring continuous venovenous hemodiafiltration
- Septic patients,severe sepsis or septic shock
Key exclusion criteria (8 listed)
- Subjects with a history of true allergy or adverse drug reactions
- Pathogens whose antibiotic susceptibility is not proved.
- Patients having impaired hepatic function
- Contraindication of anticoagulation by heparin
- Residual renal function
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/tazobactamAlso: Tazocillinepiperacillin 4 g and tazobactam 500 mg during 30 min IV infusion every 8h during 2 consecutive days | Drug | Pharmacokinetic |
| Pharmacokinetic | Procedure or surgery | Pharmacokinetic |
Primary outcome
Serum levels of both piperacillin and tazobactam (Cmin) during 2 daus
Time frame: 2 days
1 secondary outcome
Body clearance
Time frame: 2 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 24 Jan 2013.
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.
LAVAYSSIERE Laurence, MD principal investigator
University Hospital, Toulouse
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/tazobactam and Pharmacokinetic in people with Diffusive and Convective Clearance and Body Clearance, run by University Hospital, Toulouse at 1 site in France.
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 6 inclusion and 8 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 24 Jan 2013. 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 France. 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?
Serum levels of both piperacillin and tazobactam (Cmin) during 2 daus (time frame: 2 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 24 Jan 2013.