ObesityNCT01923363

PK/PD of High Dose Pip/Tazo in Obese Patients

A study testing Piperacillin/Tazobactam Standard Dose to High Dose in people with Obesity, run by Loma Linda University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 89 years
Conditions the study is for: Obesity
What is being tested?: Piperacillin/Tazobactam Standard Dose to High Dose
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 29 participants
Where: 1 siteUnited States
Study dates: 25 Feb 2014to 23 Jan 2016
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 89 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

BMI greater than or equal to 30 kg/m2
Weight at least 105 kg
Age 18-89 years of age
Prescribed piperacillin/tazobactam at standard doses for suspected or confirmed infection(s)
English or Spanish speaking
Central line access

Who cannot join

Do not meet specified inclusion criteria
Hepatic impairment classified by Child-Pugh Class B or greater
Documented pre-existing seizure disorder
Documented pre-existing hematologic disorder
Pregnancy
Documented allergy or contraindication to beta-lactams or tazobactam

Trial locations and contacts

1 site in 1 country.

United States1 site

Loma Linda University Medical Center
Loma Linda, California, 92350

Other trials in United States

About this study

Official title: Pharmacokinetics and Pharmacodynamics of High-Dose Piperacillin/Tazobactam in Obese Patients

Worldwide rates of obesity have doubled in the last 30 years, and obesity has been associated as a risk factor for hospital-acquired infections and increased occurrence of death in critically-ill patients. Piperacillin/tazobactam is a commonly prescribed antibiotic for critically ill patients with an infection, however, limited information exists for dosing this drug in obese patients. In these limited reports, standard doses of piperacillin/tazobactam given to the small number of obese patients resulted in lower blood concentrations, which could lead to inadequate killing of bacteria. The purpose of this study is to compare blood concentrations from standard piperacillin/tazobactam dosing compared to higher dosing regimens in obese patients. This study will also include information on the safety and tolerability of the higher dose regimens. The study investigators believe that the higher dosing regimen will produce adequate blood levels in obese patients and will not add any more risk of harm to obese patients receiving this higher dose.

Conditions: Obesity
Being tested: Piperacillin/Tazobactam Standard Dose to High Dose
Keywords: pharmacokinetics, obesity, piperacillin-tazobactam combination product, pharmacodynamics, piperacillin/tazobactam
Medical subject headings: Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Piperacillin/Tazobactam Standard Dose to High DoseDrug
Also called Zosyn
Patients will receive a standard dose of piperacillin/tazobactam, then will have subsequent pharmacokinetic analyses on the blood concentrations drawn while on standard dose. Patients will be switched to higher dose after receiving the standard dose, with subsequent pharmacokinetic analyses performed on those blood concentrations while on higher dose. These pharmacokinetics of each dosing regimen will be compared.

Study groups in NCT01923363
Study group	Role	What they receive
Standard Dose to High Dose Piperacillin/Tazobactam	Experimental	Patients will receive a standard dose of piperacillin/tazobactam, then will have subsequent pharmacokinetic analyses on the blood concentrations drawn while on standard dose. Then, they will be switched to higher dose, with subsequent pharmacokinetic analyses performed on those blood concentrations while on higher dose. These pharmacokinetics of each dosing regimen will be compared. Receives: Drug: Piperacillin/Tazobactam Standard Dose to High Dose

What is being measured

The primary outcome is the main question the study is designed to answer.

Serum Maximum Concentrations for Piperacillin
Pharmacokinetic parameters for piperacillin of maximum serum concentration (Cmax) will be measured in both standard dosing and high dosing.
Measured: 0, 1, 3, and 6 hours post-dose
Serum Minimum Concentrations of Piperacillin
Minimum serum concentrations (Cmin) of piperacillin will be measured in both standard and high doses
Measured: 0, 1, 3, and 6 hours post-dose

Secondary outcomes (2)

Half-life of Piperacillin
Half-life (t1/2) of piperacillin will be calculated from serum concentrations in both standard and high doses
Measured: 0, 1, 3, and 6 hours post-dose
Volume of Distribution of Piperacillin
Volume of distribution (Vd) of piperacillin will be calculated from serum concentrations in both standard and high doses
Measured: 0, 1, 3, and 6 hours post-dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

25 Feb 201423 Jan 2016

First posted15 Aug 2013 (estimated)
Study start25 Feb 2014
Primary completion23 Jan 2016
Study completion23 Jan 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for ObesityStudies of the same condition, open and under way.
More trials run by Loma Linda UniversityThe 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 N/A
Primary purpose: Basic science
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 29 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01923363
Sponsor's protocol ID: 5130259
Status last verified: Oct 2018
First submitted: 8 Aug 2013
Last updated: 26 Oct 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: No

Publications

Veillette JJ, Winans SA, Maskiewicz VK, Truong J, Jones RN, Forland SC. Pharmacokinetics and Pharmacodynamics of High-Dose Piperacillin-Tazobactam in Obese Patients. Eur J Drug Metab Pharmacokinet. 2021 May;46(3):385-394. doi: 10.1007/s13318-021-00677-1. Epub 2021 Mar 20.
PubMed 33743171

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Obesity trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Pharmacokinetics and Pharmacodynamics of High-Dose Piperacillin/Tazobactam in Obese Patients
ClinicalTrials.gov ID: NCT01923363
Acronym / sponsor ID: 5130259
Conditions: Obesity
Keywords: pharmacokinetics, obesity, piperacillin-tazobactam combination product, pharmacodynamics, piperacillin/tazobactam
Study type: Interventional
Recruitment status: Completed
Enrolment: 29 participants (actual)
Lead sponsor: Loma Linda UniversityUniversity, hospital or other
Study start: 25 Feb 2014 (actual)
Primary completion: 23 Jan 2016 (actual)
Study completion: 23 Jan 2016 (actual)
First posted: 15 Aug 2013 (estimated)
Results: Posted 26 Oct 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Basic science
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Standard Dose to High Dose Piperacillin/Tazobactam	Experimental	Drug: Piperacillin/Tazobactam Standard Dose to High DosePatients will receive a standard dose of piperacillin/tazobactam, then will have subsequent pharmacokinetic analyses on the blood concentrations drawn while on standard dose. Then, they will be switched to higher dose, with subsequent pharmacokinetic analyses performed on those blood concentrations while on higher dose. These pharmacokinetics of each dosing regimen will be compared.

Who may qualify

Ages: 18 to 89 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

BMI greater than or equal to 30 kg/m2
Weight at least 105 kg
Age 18-89 years of age
Prescribed piperacillin/tazobactam at standard doses for suspected or confirmed infection(s)
English or Spanish speaking

Key exclusion criteria (6 listed)

Do not meet specified inclusion criteria
Hepatic impairment classified by Child-Pugh Class B or greater
Documented pre-existing seizure disorder
Documented pre-existing hematologic disorder
Pregnancy

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 Standard Dose to High DoseAlso: ZosynPatients will receive a standard dose of piperacillin/tazobactam, then will have subsequent pharmacokinetic analyses on the blood concentrations drawn while on standard dose. Patients will be switched to higher dose after receiving the standard dose, with subsequent pharmacokinetic analyses performed on those blood concentrations while on higher dose. These pharmacokinetics of each dosing regimen will be compared.	Drug	Standard Dose to High Dose Piperacillin/Tazobactam

Primary outcome

Serum Maximum Concentrations for Piperacillin
Time frame: 0, 1, 3, and 6 hours post-dose
Pharmacokinetic parameters for piperacillin of maximum serum concentration (Cmax) will be measured in both standard dosing and high dosing.
Serum Minimum Concentrations of Piperacillin
Time frame: 0, 1, 3, and 6 hours post-dose
Minimum serum concentrations (Cmin) of piperacillin will be measured in both standard and high doses

2 secondary outcomes

Half-life of Piperacillin
Time frame: 0, 1, 3, and 6 hours post-dose
Volume of Distribution of Piperacillin
Time frame: 0, 1, 3, and 6 hours post-dose

Results and safety

Results posted to the registry on 26 Oct 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Piperacillin/Tazobactam Standard to High Dose	29	28

Primary outcome: Serum Maximum Concentrations for Piperacillin

Time frame: 0, 1, 3, and 6 hours post-dose. Mean (Full Range). Unit: milligrams per liter

Measure	Standard Dose to High Dose Piperacillin/Tazobactam n = 28
Group 1 (CrCl >/= 80 mL/min) on 3.375 grams	136 (107 to 179)
Group 1 (CrCl >/= 80 mL/min) on 4.5 grams	190 (149 to 247)
Group 1 (CrCl > 80 mL/min) on 6.75 grams	237 (96.4 to 368)
Group 1 (CrCl >/= 80 mL/min) on 9 grams	332 (283 to 417)
Group 2 (CrCl >/= 40 to < 80 mL/min) on 3.375 gram	144 (99.1 to 184)
Group 2 (CrCl >/= 40 to < 80 mL/min) on 4.5 grams	214 (211 to 215)
Group 2 (CrCl >/= 40 to < 80 mL/min) on 6.75 grams	244 (172 to 350)
Group 2 (CrCl >/= 40 to < 80 mL/min) on 9 grams	191 (191 to 191)

Population analysed: The # of participants in the rows below will be double the overall participant number because each patient had two different dosing regimens of pip/tazo In Group 3, 4.5g group N = 5 represents low and high dose - 2 patients receiving 4.5g upon enrollment and increased to 6.75g; 3 patients were receiving either 2.25g or 3.375g and increased to 4.5g

Primary outcome: Serum Minimum Concentrations of Piperacillin

Time frame: 0, 1, 3, and 6 hours post-dose. Mean (Full Range). Unit: milligrams per liter

Measure	Standard Dose to High Dose Piperacillin/Tazobactam n = 28
Group 1 (CrCl >/= 80 mL/min) on 3.375 grams	8.9 (0.0 to 44.1)
Group 1 (CrCl >/= 80 mL/min) on 4.5 grams	11.1 (1.4 to 18.2)
Group 1 (CrCl >/= 80 mL/min) on 6.75 grams	27.0 (8.6 to 72.6)
Group 1 (CrCl >/= 80 mL/min) on 9 grams	10.3 (0.57 to 29.4)
Group 2 (CrCl >/= 40 to 80 mL/min) on 3.375 grams	47.4 (24.1 to 75.4)
Group 2 (CrCl >/= 40 to 80 mL/min) on 4.5 grams	52.5 (49.4 to 55.6)
Group 2 (CrCl >/= 40 to 80 mL/min) on 6.75 grams	72.6 (37.5 to 128)
Group 2 (CrCl >/= 40 to 80 mL/min) on 9 grams	54.1 (54.1 to 54.1)

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Each patient was monitored daily for adverse reactions from study enrollment until two weeks after piperacillin-tazobactam was discontinued or until hospital discharge, whichever was sooner. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Standard Dose to High Dose Piperacillin/Tazobactam	1 of 29 (3.4%)	6 of 29 (20.7%)	0 of 29

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 33743171Veillette JJ, Winans SA, Maskiewicz VK, Truong J, Jones RN, Forland SC. Pharmacokinetics and Pharmacodynamics of High-Dose Piperacillin-Tazobactam in Obese Patients. Eur J Drug Metab Pharmacokinet. 2021 May;46(3):385-394. doi: 10.1007/s13318-021-00677-1. Epub 2021 Mar 20.
Individual participant dataSharing planned: No

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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.

Steven C Forland, PharmD principal investigator

Loma Linda University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Piperacillin/Tazobactam Standard Dose to High Dose in people with Obesity, run by Loma Linda University at 1 site in United States.

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 6 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 26 Oct 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 United States. 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.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Oct 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 Maximum Concentrations for Piperacillin (time frame: 0, 1, 3, and 6 hours post-dose). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01923363, which also lists 1 linked publication.

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 26 Oct 2018.